| Fundamentals of Clinical Research & GCP - (Short Course) |
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| This 1-day course is a plain language guide to product development, clinical trial methodology and terminology and essentials of GCP. No prior knowledge or experience is required. This course is ideal for new personnel, those in non-technical roles requiring basic knowledge of clinical trials and GCP responsibilities, administrators, members of non-clinical departments in commercial companies and members of ethics committees. The course is the first day of our Foundation in Clinical Research course. | | Future dates | 16 November 2010 | | Funding/Fees | £450 (ex VAT) | | Date(s) | 14/09/2010 |
| Introduction to Clinical Trials & Clinical Trials Practice - (Short Course) |
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This course is designed to educate delegates in the role of clinical research in drug development and in clinical trials methodology and instruct them in the principles of Good Clinical Practice.
An introduction to:
• Drug development
• Statistics for CRAs
• Protocol design
• Clinical trial design and theory workshop
• Case report form design
• Pre-trial organisation
• Ethics committees and informed consent
• Introduction to GCP and investigator selection and motivation
• Source data verification and clinical trial monitoring
• Quality assurance
• Phase I studies
• Adverse effects and adverse drug reactions
• Regulatory affairs | | Funding/fees | Member £1100
Non-member £1320
Member Health Service / Academic £899 | | Date(s) | 27/09/2010 to 29/09/2010 |
| Market Research - An Introduction - (Short Course) |
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On completion of the course registrants should have an understanding of:
1 The basics of market research
* Research objectives
* Research design
* Content
* An introduction to research methodologies
2 Designing a research project: the tools of market research
* Introduction to qualitative research
* Introduction to quantitative research
* Introduction to sampling and interviewing
* An introduction to questionnaire design
3 Completing a research project
* Turning data into findings
* Reporting and communicating findings
* Professional development and the market research industry. | | Requirements | The course will provide a basic introduction and may be particularly suited to support staff, those commissioning research for the first time, those wishing to carry out small-scale research to support their businesses, field workers and those seeking an understanding of the market research industry.
| | Funding/fees | Prics £175 + VAT |
| How To Be An Effective CRA - (Short Course) |
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Understand the role and responsibilities of the CRA and learn how to be really successful.
This two-day course is ideal for CRAs with less than two years of experience, and recent graduates who are interested in becoming a CRA. By the end of this course, delegates will be able to:
* Understand the importance of your role in the clinical trial process
* Understand how your role is impacted by industry standards and guidelines
* Communicate effectively and assertively in all situations
* Manage your time more effectively
* Prepare for an Audit or Inspection and be confident in identifying and dealing with fraud. | | Funding/fees | £1290 + VAT | | Date(s) | 06/12/2010 to 07/12/2010 |
| Introduction To Data Management - (Short Course) |
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This course is suitable for everyone who is new to the industry or is working in a support role within or alongside a Data Management team.
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| Introduction to Drug Development - (Short Course) |
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An overview of the drug development process including drug discovery, clinical research and the workings of the drug development industry.
This course is perfect for anyone who is new to the industry or works in a support function and needs to understand the
jargon and terminology that surrounds them.
This course will help you:
* Understand the complexity of drug development and the time, money and resources required
* Learn how new drugs are identified, researched and developed
* Gain an insight into the marketing and sales of drugs and the importance of what will be bought
* Understand how drugs already on the market are a driver for new drugs under development.
Programme:
* Introduction & Objectives
* The Pharmaceutical Industry
* Drug Development
- The drug development process
- Investigating products
- Toxicology
- ADME (Absorption, Distribution, Metabolism, Excretion)
* Pharmacology & Therapeutics
- Assessment of the effects of drugs in patients
* Clinical Trials
- Overview of the clinical trial process
- Protocol design
- Ethics Committees
- Data Management
* Regulatory Affairs
- Introduction to Regulatory Affairs
- Regulatory Control of Clinical Trials
- The Regulatory Process
* International Conference on Harmonisation (ICH)
* Marketing & Sales
- Legal Categories
- Marketing & Selling Pharmaceuticals
- Pharmaceutical Markets
* Review. | | Funding/Fees | £599 +vat. If you book on the course more than 9 weeks in advance, a 10% discount will be applied. | | Date(s) | 28/10/2010 |
| What Every Pharmaceutical Administrator Needs to Know - (Short Course) |
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An overview of all of the main areas of the drug development industry, specifically for administrators and CTAs too.
This course is of interest to anyone who is an administrator (including CTAs, PAs, secretaries and receptionists) and needs a better understanding of the clinical trials process and how they can support it. It will demystify the jargon and explore the different departments and how they interact with one another.
By the end of this course, you will be able to:
* Understand the clinical trials process and its key stages.
* Understand clinical trial terminology.
* Understand how different organisations interact and the roles of the different departments.
* Have a good enough understanding of the process to generate your own ideas on how best to use your new knowledge.
* Work more effectively which will benefit you in terms of motivation and career advancement. | | Funding/Fees | The full fee for this course is £590 + vat and includes full course materials, lunch and refreshments. | | Date(s) | 09/11/2010 |
| Foundation Course in Clinical Research (BASIC COURSE) - (Short Course) |
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A 2-day certification course covering the basics of clinical research & GCP. Ideal for the new or inexperienced and essential for those wishing to attain certification. This course incorporates the Fundamentals of Clinical Research & GCP course (Day 1)
Faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the United Kingdom) has awarded 13 CPD credits to this course
We use visual, auditory and kinaesthetic learning methods to make the course fun and enjoyable.
Objectives and Course Content
Participants of courses learn in different ways. Our foundation course has been designed to ensure that all the visual, auditory and kinaesthetic methods of learning are incorporated. We have drastically reduced the use of PowerPoint presentations and included non-threatening activities. These both enhance learning and make the course far more enjoyable for the participants.
No prior experience is required but participants will gain most benefit if they have worked in the field of clinical research for at least six months prior to attendance.
At the end of the course participants should have a thorough basic knowledge of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities.
Our last course in Copenhagen attracted a vast number of enthusiastic comments about our new teaching style, including ....
"Finally a course where you don't just sit down and listen for hours all the time. Excellent with interactive sessions — it certainly kept my attention".
"Thank you very much — I never thought learning GCP could be so interesting"
"A fantastic course with extremely competent teachers who know how to explain the topics in an easy to understand way"
This course covers and participants will be made aware of:
* the process of the development of a new medicinal product through the various phases of clinical research (Phases I to IV and PMS)
* the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use)
* plain language explanations of abbreviations, methodology and terminology including study designs (parallel group/crossover), blinding methods, use of placebo
* introduction of GCP and its implementation by standard operating procedures. | | Funding/fees | New two-day course, price reduced to £950 (ex VAT)
Clinical Research Club: £875 (ex VAT) | | Date(s) | 14/09/2010 to 15/09/2010 |
| Advanced Course in Clinical Research (& Cert CRGCP Part 2) - (Short Course) |
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| This 1-day course covers advanced and practical topics not covered in Part 1. It gives participants the chance to develop their project management and problem solving skills. General awareness information is provided about the new European requirements for interventional trials in humans. Participants who have passed the basic course examination and have attended this course are eligible to sit the optional examination for the “Certificate in Clinical Research & GCP”. The course is also open to participants who do not wish to take the examinations or attain certification. | | Future dates | 18 November 2010 ** | | Requirements | This is an advanced course ideal for those who have already attended the Fundamentals course or have experience in the clinical trial process | | Funding/Fees | Next 1-day course, £450 (ex VAT) - Pay online
| | Date(s) | 16/09/2010 |
| Practical Introduction to Running Randomised Clinical Trials - (Short Course) |
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This 3 day course will improve your knowledge and skills in the design, practical conduct, management and analysis of randomised clinical trials (RCTs). Combining talks and workshop activities, you will be guided through the principles, methodology and practical implementation of RCTs.
Course content -
•Day 1 Key principles and critical appraisal of randomised clinical trials
•Day 2 Managing randomised clinical trials: Key issues from protocol to implementation
•Day 3 Data issues in the implementation and analysis of randomised clinical trials. | | Requirements | • Individuals who are new to clinical trials, those embarking on clinical trial research and those with some experience of designing and running trials.
• Individuals from the full range of clinical researchers, including allied healthcare professionals, and non clinical researchers, including trial managers and R&D managers.
• Individuals interested in clinical trials in the primary care setting, at the primary / secondary care interface and in secondary care. | | Funding/fees | £375.00 |
| Understanding the Regulation 21 CFR Part 11 Training - (Workshop/Seminar) |
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| This course seeks to provide an understanding of the regulation and an update on the latest published guidance. | | Future dates | * 14th October 2010 Belfast
* 11th November 2010 Northamptonshire
* 2nd December 2010 London | | Funding/fees | Please check website for details of fees. | | Date(s) | 16/09/2010 |
| EU Clinical Trials Directive - (Workshop/Seminar) |
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| The practical effects of the Clinical Trial Directive 2001/20/EC regulations are widespread and on-going. What impact is the Directive having on your clinical trials? Are you losing valuable time seeking clarification? This intensive 2-day interactive training course has been designed to help you meet the challenges of the EU Clinical Trials Directive head-on. Practical sessions, step-by-step guidance and group discussions will help you to perform your responsibilities in line with Directive and reach your targets with a timely and compliant strategy. | | Requirements | Who should attend? Clinical Trials Manager' Regulatory Affairs Manager, GMP Inspector, Clinical Development Manager, Clinical Process Manager Medical Advisor, International/Global Regulatory Affairs Manager, Quality Control/Assurance Manager, Clinical Research Manager, Scientific Affairs Manager, GCP manager, QC Associate Drug Safety Manager, Clinical Operations Manager Clinical Project Leader, Pharmacovigilance Statistician, Biostatistician, Data Manager Clinical Pharmacologist, Clinical Pharmacology, Drug Evaluation Manager, Medical Director.
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| Writing and Managing SOPs for Clinical Quality Assurance - (Workshop/Seminar) |
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SOPs play a crucial role in clinical quality assurance and it is therefore essential that they are understood and followed by all end-users in a clinical trial. If SOPs are not followed correctly, the validity of data generated is compromised, leading to warning letters being issued and delays in the trial process. Auditors and inspectors see SOPs as essential and following them is crucial.
In this highly interactive course you will develop the skills and practical experience required to write and review SOPs for GCP compliance. Participants will review GCP fundamentals and also relevant regulations. This knowledge will then be used to examine considerations of style, length and content. | | Requirements | This course is beneficial to all involved in writing or managing SOPs for clinical trials, particularly those working in the following departments:
* Quality Assurance
* Clinical Trials
* Clinical Development
* Clinical Operations
* Clinical Research
* Clinical R&D
* Clinical Project Management | | Date(s) | 29/11/2010 to 30/11/2010 |
| Adverse Event Reporting and Pharmacovigilance - (Workshop/Seminar) |
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Product recall is a real disaster, especially when it could have been avoided through accurate drug safety reports and quick reaction to postmarket safety issues. Industry cannot afford to waste the investments made in the clinical and marketing activities of new products through poor ADR reporting practices.
This course will review the regulatory environment in which you operate and will guide you through the vast number of Directives, regulations and guidelines. You will be given the chance to work on case study exercises to produce practical advice and develop adequate strategies to handle reporting requirements.
If you need to gain in-depth knowledge on the best way to prepare for, collect and report adverse events, then this is the course for you. Its unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.
Performance & Knowledge Objectives of this Course:
* Effectively monitor your drug reactions and avoid being blamed for negligence
* Minimise post-marketing issues that can adversely affect your drug sales revenue
* Perform accurate causality assessment to identify the exact origin of your ADRs
* Identify and follow up the key signals over time to take preventive actions
* EU requirements: what are the Directives, regulations and guidelines and when do they apply?
* Compile and present key information in your adverse event reports in a clear format and reduce errors of interpretation
* Examine the practical impact of global harmonisation: ICH and CIOMS
* Prepare periodic safety update reports (PSUR) within the required timeframe. | | Future dates | 6 Dec 2010 - 7 Dec 2010 - Regus St James's Park, London | | Date(s) | 21/09/2010 to 22/09/2010 |
| A Practical Guide to Pharmacovigilance and Drug Safety - (Short Course) |
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This 10-week self-study course has been specifically designed to give you a thorough understanding of pharmacovigilance and drug safety. Led by leading industry consultant Graeme Ladds, this course will teach you how to:
*Ensure your drug safety standards are being performed on a regular basis to avoid punitive measures being taken against you.
*Keep abreast of all the new safety reporting requirements so that you can run an efficient compliant safety department.
*Plan an effective surveillance system to monitor potential new signals and readjust risk/benefit for your products.
*Understand safety requirements and prepare for the increasing number of pharmacovigilance inspections conducted by regulatory agencies.
*Write standard operation procedures (SOPs) to cover the various aspects of drug safety and advise your staff on the requirements of safety reporting.
*Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments.
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| Introduction to Regulatory Affairs for Biotechnology - (Workshop/Seminar) |
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This 2-day introductory course, the second in our Regulatory Affairs for Biotech curriculum, has been specifically designed for Regulatory Affairs professionals who are new to the Biotech industry. The training will provide a solid foundation on which to move forward in this ever-changing environment.
Gain a thorough overview of the Biotech industry - clarifying the latest requirements for regulatory compliance, how to achieve approval and how to predict the effects of changing technologies. Be confident in your dealings with global agencies with our interactive discussion groups and varied case studies.
What Will You Learn?
* Clarify and comply with regulatory requirements for biotech vs. synthetic-based drugs
* Meet validation requirements during the different stages of biotech drug development
* Identify the differences in EU and US submission regulations.
Performance & Knowledge Objectives
* Examine the biotech industry and its impact on drug development
* Clarify the criteria for submitting biotech applications vs. synthetic-based products
* Build validation programmes to support different stages of development
* Compare EU and US drug submission procedures
* Identify the latest regulatory requirements and compliance strategies available. | | Date(s) | 21/10/2010 to 22/10/2010 |
| Regulatory Affairs Strategies - (Workshop/Seminar) |
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This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.
This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.
What Will You Learn?
* Formulate regulatory strategies that achieve first class regulatory performance and compliance
* Speed up drug registration through skilled utilisation of registration procedures
* Reconcile R&D, clinical and marketing demands within the regulatory framework
* Manage the practical hurdles of submitting MAA/CTD within the deadlines
* Negotiate and respond to regulators’ questions successfully
* Understand the impact for your RA strategy of your product’s therapeutic area, proposed indications and other technical and development features
* Collect and present key information for the submission dossier to achieve a winning strategy
* Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from regulators. | | Date(s) | 29/09/2010 to 30/09/2010 |
| Clinical Trial Administration; an Introduction - (Short Course) |
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| This course aims to provide an introductory training for the CTA to help make sense of the background to clinical research and trial management. | | Future dates | 9th November 2010 | | Additional Information | CPD Points: 10 | | Date(s) | 07/09/2010 |
| Effective Clinical Trial Project Management - (Short Course) |
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The aim of this course is to provide delegates with basic project management techniques that can be applied to clinical trials.
Course outline
• Definition of project management terms
• What does a project manager manage?
• The life cycle of a project
• Defining a project – developing a project objective
• Project constraints
• Feasibility studies & assessing risk
• The major steps in planning a project
• Developing a work breakdown structure
• Producing estimates
• Agreeing responsibilities
• Managing the project team
• Creating a task network and schedule
• Task dependencies
• Critical path analysis
• Analysis of resource requirements
• Analysing the plan for risk
• Tracking the project and dealing with variance
• Tracking and managing change
• Project close-out | | Requirements | The course is designed for delegates new to the role of clinical trial project management. | | Funding/Fees | Member £1200
Non-Member £1440
Member Health Service / Academic £950
| | Date(s) | 26/10/2010 to 28/10/2010 |
| Introduction to Clinical Research - (Workshop/Seminar) |
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The drug development process is complex, expensive, high risk and on average can take 12 years to complete. Clinical research has a pivotal role in the process and through the first three phases the efficacy and safety profile will be determined. However, both need to be explored in more detail after approval for marketing and during this phase a more complete picture of safety and efficacy emerges. This course will cover the full range of clinical research activities, bringing together the important features of this process and including how the complementary activities conducted in various departments result in a successful clinical project.
• The evolution of the pharmaceutical industry
• The phases of drug development
• Some common abbreviations
• History of GCP
• EU GCP Directive
• EU Clinical Trials Directive
• Roles and responsibilities in clinical research
• Life cycle of a clinical trial
• The protocol and case report form
• Informed consent
• Safety reporting
• Data flow
• Marketing Authority Applications
• The marketing and selling of medicinal products | | Funding/Fees | Member £425
Non-Member £510
Member Health Service / Academic £335 | | Date(s) | 01/12/2010 |
| Certificate in Good Clinical Practice - (Short Course) |
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Almost every aspect of pharmaceutical medicine is subject to regulation and for many years it has been a requirement of regulatory authorities that clinical trials performed to support licensing of new medicines be conducted in compliance with a set of standards known as Good Clinical Practice (GCP). Therefore pharmaceutical physicians, clinical research scientists, research nurses and others employed within the industry are required to have a good working knowledge of GCP. Most pharmaceutical companies provide training courses for their personnel either in-house or externally. However, for the most part training has not extended to clinicians, research nurses, technicians and other personnel serving as investigators and support staff involved in the conduct of clinical trials. Furthermore, there has been no qualification in GCP widely recognised as evidence of attaining a satisfactory standard of knowledge. The importance of attaining adequate knowledge of GCP extends beyond the investigation of potential new pharmaceuticals since an EU Clinical Trial Directive stipulates that from 2004 all clinical trials on human subjects involving medicinal products in the European Union, irrespective of their purpose, must be conducted in compliance with GCP. In the UK the EU Clinical Trial Directive was implemented from 1st May 2004.
The examination will be held in the UK but candidates may be from any country. Successful candidates will be awarded the Certificate of GCP. To gain the required standard in the examination, candidates will need to prepare themselves. The next examination will be held on 15th June 2009 at the Royal College of Physicians, London. | | Requirements | There are no specific eligibility criteria to register for the Certificate examination. It is open to all personnel involved in the conduct of clinical trials including research nurses, clinical research scientists and technicians as well as physicians. The examination will be held in the UK but candidates may be from any country. |
| Annual Conference 2010 - Counterfeits, Clinical Trials and Aseptic Processing - (Conference) |
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One Day Conference with Exhibition
Programme includes:
* Registration and Coffee
* Conference Introduction and AGM summary
* MHRA – Leading MHRA GMP inspector will present on topical issues.
* Counterfeiting – Title to be confirmed
* Workshop 1 – Virus manufacture in a GMP Aseptic process for Clinical trials
* Workshop 2 – Freeze Drying
* Workshop 3 – Pharmaceutical Due Diligence
* Workshop 4 – Clinical Trials
* George Sykes Memorial Award
* Counterfeiting Risk Assessment – Another QP Role
* Aseptic Manufacturing. | | Funding/fees | Member £ 350.00+ VAT, Non Member £ 450.00 + VAT. | | Date(s) | 14/10/2010 |
| Introduction to Clinical Research - (Short Course) |
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This course is suitable for anyone who is new to Clinical Trials, and needs an understanding of the industry, clinical research and clinical trials. The course can be tailored to a variety of audiences including new recruits and adminstrative staff.
Basic Outline:
Background to the Industry
* The Industry Today
* New Product Development
* Patent Protection
* Race for Approval
Product Discovery
* Target Identification
* Target Validation/Prioritisation
* Lead Identification
* Lead Optimisation
Preclinical Development & Chemistry
* Preclinical Testing
* Chemistry & Manufacturing Considerations
Clinical Development/Clinical Research
* Stages of Clinical Research
* Phase I & Early Stage Clinical Research
* Phase II
* Phase III
* Late Phase
* Phase IIIb
* Phase IV
* Post Marketing Surveillance (PMS)
* Generic Products
Overview of Process for a Clinical Trial
* Protocol
* Obtain Relevant Approvals
* Design Case Report Form (CRF)
* Product Supply
* Recruit, Manage & Monitor Subjects/Patients
* Data Management
* Analyse & Report Data
Organisations involved in clinical research
* Organisations primarily interested in the outcome of research
* Organisations taking part in conducting the clinical research
* Organisations providing clinical research services
| | Requirements | Information on fees can be found at: http://www.pharmaschool.co.uk/rfq.htm |
| Adverse Drug Reactions, Drug Interactions, and Pharmacovigilance - (Short Course) |
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| This course is aimed at qualified doctors, especially specialist registrars in clinical pharmacology or in training for other medical sub-specialities; clinical research fellows in other specialities; pharmacists; nurses; graduates working in the pharmaceutical industry. |
| Annual Partnerships in Clinical Trials |
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PARTNERSHIPS IN CLINICAL TRIALS 2010 WILL DELIVER:
* Strategic and practical case studies of the industry's most successful clinical partnerships
* Expert analysis on the global economy (and the implications for Pharma)
* Comprehensive update of the changing service provider market
* Thorough industry analysis from large, medium and small Pharma/biotech companies
* Inspiring out-of-industry.
| | Date(s) | 17/11/2010 to 18/11/2010 |
| HSRPP 2011 - Research in Partnership - (Conference) |
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| This conference aims to bring together existing researchers and practitioners interested in health services research to achieve the conference aims of disseminating the latest research and encouraging research ideas. This year additional sessions will support partnership working with industry, patients and the public. There will also be educational sessions in qualitative and quantitative research skills, getting published and securing grant income. | | Date(s) | 05/05/2011 to 06/05/2011 |
| Successful Medical Writing |
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Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.
| | Funding/fees | €1800 | | Date(s) | 22/09/2010 to 24/09/2010 |
| Essential Documents - (Short Course) |
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Conducting clinical trials requires a vast amount of documentation. Knowing what the required documentation is at each stage of a trial is essential knowledge for anyone working in trials. Many people start their careers in industry by being a Clinical Trial Assistant (CTA). The CTA role requires an extensive knowledge of documentation and this module is ideal as an introduction or equally as a revision method to help progress to the next level which is often a CRA role. This module details the guidelines and regulations governing the documents, explains what they are and why they are needed as well as providing information about where these should be filed.
Course Contents:
* Introduction
* Section 1: Why Do We Have To Have Them?
* Section 2: Where Do I Start?
* Section 3: Before The Trial 1 - Protocol And Approvals
* Section 4: Before the Trial 2 - Subject Documents
* Section 5: Before the Trial 3 - IMP Documents
* Section 6: Before the Trial 4 - Administration
* Section 7: During the Trial
* Section 8: After the Trial | | Requirements | The module is designed for anyone involved in Clinical Trials at either the sponsor side, a CRO or at a trial site. The module is ideal for those wishing to enter the industry to help them at interview to demonstrate an understanding of the role of a CTA, CRA or SSC. |
| Introduction to Regulatory Affairs for Medical Devices - (Short Course) |
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Practical solutions for compliant medical device submissions.
This practical 2-day introductory-level training course will examine the complex processes involved in meeting the EU regulatory requirements associated with medical Devices.
From early decisions regarding the most appropriate conformance route of a product, through to post marketing adverse event reporting, delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety. | | Future dates | 18 Oct 2010 - 19 Oct 2010 - | | Date(s) | 18/10/2010 to 19/10/2010 |
| Clinical Research Project Management - (Short Course) |
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Would you like to find out how you could make a difference and have an impact on the bottom line?
-If your answer is YES! . . . then read on and find out how this course can provide you with the additional training you need to perform better in your role.
Setting up and running clinical trials is a complex process. More and more people are looking for ways to improve the results of their clinical projects.
Successfully implementing project management techniques is imperative within the increasingly cost and time conscious pharmaceutical environment | | Requirements | All clinical research professionals who are or will be involved in clinical research projects will benefit from this course, including:
- Clinical Research
- Clinical Projects
- Clinical Development
- R&D Projects | | Date(s) | 08/11/2010 to 10/11/2010 |
| World Drug Safety Congress Europe |
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The 2nd annual World Drug Safety Congress Americas 2010 is the premier event for drug safety and pharmacovigilance professionals in the industry calendar.
The congress hits the perfect balance between high quality scientific content, strategy-led presentations and solution based discussions on the most pertinent issues impacting drug safety. | | Funding/fees | https://secure.terrapinn.com/V5/rCalc.aspx?E=3264 | | Date(s) | 14/09/2010 to 17/09/2010 |
| Pharmacokinetics In Drug Discovery and Development - (Conference) |
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| Pharmacokinetics and metabolism are now accepted as key disciplines in drug development providing an insight into differences in drug action within and between species. Unfortunately for many people it is also one of the more complex to understand and to put into practice, particularly with the new approaches such as in-vivo metabolism, genetic polymorphism, interaction studies, kinetic-dynamic modelling, bioavailability, population kinetics, biotechnology etc. The lecturers, who come from academia, industry and the regulatory agency, have many years’ experience in this area. They will provide information on the use and benefits of pharmacokinetics in drug development and how it affects drug discovery. Allowances have beenmade within the programme for discussion so that particular problems can be considered in detail. | | Requirements | Directors and staff of pharmaceutical companies, particularly those in Clinical and Preclinical Research Departments, Regulatory Affairs, Registration, Licensing, including Product Managers and all those interested in the use of pharmacokinetics in drug development.
This seminar is NOT aimed at the expert pharmacokineticist, although a knowledge of basic kinetic principles would be useful. | | Date(s) | 21/09/2010 to 22/09/2010 |
| Interpretation Of Cardiac Investigations For Industry Clinical Trialists - (Short Course) |
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This two-day course is designed to introduce pharmaceutical researchers in the field of cardiovascular trials to be familiarised with different cardiac investigations which are commonly used in conducting cardiology trials. The course covers patho-physiological background of different cardiovascular diseases and conditions and interpretation of the changes which is relevant for cardiac researchers.
Programme includes:
* Introduction & Objectives
* ECG interpretations in common cardiovascular conditions
* Echocardiography, modalities and changes in common cardiac conditions
* Exercise ECG implications in cardiovascular diagnosis and assessments
* Different cardiac monitors and cardiac event recorders
* Cardiac catheterisation with haemodynamic changes and measurements, including coronary angiography
* Basis of nuclear scanning and its implications and use in cardiology. | | Funding/fees | £1,095 + vat. If you book on the course more than 9 weeks in advance, a 10% discount will be applied. | | Date(s) | 04/11/2010 |
| Interpreting Trial Results in Medical Literature - (Short Course) |
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The reading or development of medical literature is a major part of many roles in the pharmaceutical industry. In order to be able to fully effective in such a role it is essential to be able to understand how to interpret the results, how to identify limitations of the results caused by trial design and conduct as well as being able to summarise and use the seemingly complex statistical results in the papers and reports.
The course is designed for groups of delegates who regular have to create, read or summarise medical literature. The course has previously been tailored to include a review of and examples from medical literature provided by the customer. This has previously included:
* Medical Advisors
* Investigators
* Medical Information Personnel
* Medical Communication and Medical Writers
* Sales and Marketing Teams | | Funding/fees | The price for each course is £250 +VAT. If you are a freelancer, work for charity, academic institution or in the NHS then you qualify for the non-commercial rate of just £125 + VAT. |
| Health Technology Assessment World Europe 2010 - (Conference) |
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The 3rd annual Health Technology Assessment World Europe 2010 is the most influential meeting on HTA for pharmaceutical products in your 2010 events calendar. Over the course of the 4 days HTA thought leaders from the world’s leading pharmaceutical and biotechnology product manufacturers plus government agencies, academic institutions, contract service organisations and consultancies will convene to discuss pioneering HTA strategy.
This is the 3rd annual policy forum for the industry where all the major HTA agencies across the world and leading pharmaceutical pharmaceutical companies gather to discuss the challenges in obtaining market access. | | Funding/fees | Basic packages Currency: GBP (£ Pounds)
Gold pass - all 4 days - £2,385
2 day conference plus x1 workshop - £1,800
2 day conference only £1,215 | | Date(s) | 07/12/2010 to 10/12/2010 |
| Introduction To Pharmacokinetics - (Short Course) |
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This course is designed for non-specialists working in the pharmaceutical industry who need an introduction to the principles involved in clinical pharmacokinetics and the associated practicalities. The course assumes no previous knowledge and works logically through the processes by which the body deals with drugs and parameters by which these processes are measured. The emphasis throughout is on these implications of these processes and measurements for real-life drug development.
This course covers:
* The theory of ADME
* Key PK parameters
* It’s application
* The practicalities. | | Funding/fees | £599 + vat. If you book on the course more than 9 weeks in advance, a 10% discount will be applied. | | Date(s) | 10/11/2010 |
| Regulatory Affairs for Clinical Trials - (Short Course) |
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To ensure clinical trials meet the requirements of the regulatory authorities, it is essential that trials are carried out to the latest regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in regulations for running clinical trials, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. This course will also highlight the most important of these key changes, including:
- Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
- Develop effective processes for obtaining Clinical Trials Authorisation:
- Regulatory Approval and Ethical Approval
- Understand the requirements for running clinical trials in Children
- Understand the most important legal aspects of clinical trials
- Ensure compliance in regulatory requirements for investigational medicinal product, pharmacovigilance, Clinical Trial Data Management including EDC and e-source
- Explore recent developments in clinical trial regulations including FDA requirements
- Achieve successful regulatory inspection | | Requirements | The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.
The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials. | | Date(s) | 27/09/2010 to 28/09/2010 |
| Antibody Display, Selection and Engineering - (Workshop/Seminar) |
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Optimising your recombinant antibody selection and display techniques
Recombinant antibodies and the range of techniques that can be applied to them have significant advantages compared with conventional antibodies. Studies show that manufacturing times are significantly shorter and product quality is greatly improved through using recombinant methods.
This practical 2-day training course will provide delegates with the latest information on recombinant antibodies methodologies and technologies and explore the full potential of this exciting field. It will also provide a forum to enables delegates to identify common problems and share solutions through open discussion. | | Date(s) | 05/10/2010 to 06/10/2010 |
| Technology Transfer for the Pharmaceutical Industry - (Workshop/Seminar) |
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This 2-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring technology and to highlight some proven techniques for overcoming those challenges.
Some of the benefits to be derived from this workshop include:
An appreciation of where TT fits in the life cycle of a pharmaceutical product
An appreciation of the importance of planning and product transfer
An overview of the potential complexity of technology and product transfer
An outline of proven best practice in technology transfer
An opportunity to discuss current issues and challenges in technology transfer with peers and with an expert faculty | | Funding/fees | £1160 + VAT £174.00 (Total £1334.00) (10% discount if booked and paid by Friday 4 September)
| | Date(s) | 10/11/2010 to 11/11/2010 |
| Analytical Chemistry in the Pharmaceutical Industry - (Workshop/Seminar) |
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Analytical chemistry underpins pharmaceutical drug development by providing assurance of the quality, safety and efficacy of new medicines. This course is an overview of the areas in which analytical chemistry plays a vital role in developing a new drug. There is a focus on HPLC as being the most important analytical procedure in today’s pharmaceutical industry, but other techniques are also covered, for instance those used to investigate polymorphism in new drugs. The applicability of regulatory guidance, particularly that from ICH, to analytical chemistry is also covered in this course.
This course will benefit managers with a responsibility for analytical chemists. It is also recommended for project team members working alongside analytical chemists, as well as analysts requiring a broad overview of their role in the pharmaceutical industry. While covering a range of techniques, emphasis is also placed on the
responsibilities of the analytical chemist to deliver reliable data in compliance with appropriate regulatory guidance. | | Funding/Fees | £1160 + VAT |
| Annual Investing in Healthcare Conference - (Conference) |
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The healthcare sector in the UK is still a viable proposition for investors despite the economic downturn. Healthcare, by its very nature remains a necessity, rather than a discretionary purchase and remains a strong recession investment. The industry has proved resilient, stable and remarkably active despite recent financial volatility.
This conference, an annual fixture in the health and care calendar, will reflect the difficult market conditions and take in opinions from some of the country's leading healthcare analysts, providers and investors as to whether there are grounds for a more optimistic outlook. | | Date(s) | 13/10/2010 |
| Do I want to do Industry Research? - (Short Course) |
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| This presentation will identify the process of getting industry research adopted and the benefits of researchers taking part in industry research - capacity building, developing research skills and networks. It will also discuss the NHS National Costing Commercial Costing Template. | | Requirements | This course would be suitable for: Local research community. | | Date(s) | 04/11/2010 |
| DigiPharm - (Conference) |
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| Following on from the success of the 2007, 2008 and 2009 events held in London the 4th annual World Generic Medicines Congress Europe is the industries “must attend” event of the year with a packed four day meeting with expert industry speakers, high quality content, interactive networking opportunities and open discussion sessions that will bring fresh opportunities for your generic pharmaceutical strategy. | | Funding/fees | https://secure.terrapinn.com/V5/rCalc.aspx?E=3151 | | Date(s) | 28/09/2010 to 01/10/2010 |
| Analytical challenges in the qualification and validation of pharmacodynamic biomarkers - (Workshop/Seminar) |
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To discuss the current concepts in the qualification and validation of biomarker assays for the measurement of pharmacodynamic responses to drugs and vaccines. In addition to standard ELISA formats the meeting will discuss the application of other platform technologies such as Flow Cytometry, ELISpot, QPCR, Gyros, LC/MS and multiplex platforms including Luminex and Meso Scale Discovery (MSD).
The meeting will discuss the concept of a “fit-for-purpose” method qualification and validation, selection of reference material, QCs, and relevant acceptance criteria. The symposium will also address the various biomarker approaches including; clinical diagnostics, immunogenicity, companion diagnostics and the use of commercial human kits for pre-clinical applications
This symposium will be of interest to scientists engaged in preclinical and clinical development of drugs and vaccines. It will be of particular relevance to those engaged in bioanalytical or biomarker method development and validation. | | Funding/fees | * Bona fide students, retired or unemployed members of RSC or RPSGB: £36.00
* JPAG members: £151.00
* Not members of JPAG, or RSC or RPSGB: £251.00
* Other members of RSC or RPSGB ** or APSGB: £201.00. | | Date(s) | 14/10/2010 |
| Applying Nanotechnology to Improve Dentistry - (Short Course) |
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| Learn how the application of knowledge at the nanoscale and the ability to manipulate materials using nanotechnology will revolutionise medicine and the dental industry | | Requirements | The course is aimed particularly at trainee and practicing dental professionals, researchers and academics interested in novel and advanced dental materials, dental industry researchers and professionals, those involved in technology transfer and development, regulators and NHS professionals | | Funding/fees | Clinician/Academics - £250 + VAT
Industry - £400 + VAT
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| Health Economics for Pharmaceutical Personnel - (Conference) |
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| This course is aimed at those working in the pharmaceutical industry who need to be introduced to the language of economics and economic evaluation. The course will provide an understanding of the specific characteristics of health as an economic good, its measurement, the indirect nature of the demand for health and the imperfections of the market for health care. It explains how economists evaluate the costs and benefits of health interventions, and how decision makers in the health services and in the pharmaceutical and medical technology industries use health economics. NICE will be discussed and although based in the UK this will have relevance to markets across Europe. | | Funding/fees | UK£ 1975 plus VAT/taxes | | Date(s) | 30/11/2010 to 01/12/2010 |
| AT Technology Transfer - (Workshop/Seminar) |
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This is the advance notice of the above free workshop to be held in Sheffield, UK. The workshop is hosted by the Rehabilitation and Assistive Technology team at the University of Sheffield and KT-EQUAL.
The overarching theme of the meeting is 'The social model for Assistive Technology technology transfer (ATtt)'. The ATtt scope and therefore the likely sessions are expected to cover: 'Contrasting the commercial and social models of ATtt', ‘Open development’, 'Technological development and issues', 'Taking account of service delivery issues', 'Evidence gathering', 'Commercialisation approaches and issues', 'Reaching the AT customer', 'The role of Patient and Public Involvement', and ‘How AT information helps technology transfer’. A likely cross cutting theme will be the financing of the processes to meet the social and ethical aspirations of the social model.
Currently the workshop duration is expected to be 2 full days. | | Date(s) | 04/10/2010 to 05/10/2010 |
| Internal Auditor: ISO 13485 Medical Devices - (Workshop/Seminar) |
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| BSI’s “Internal Auditor: ISO 13485” course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485:2003 and evaluate the effectiveness of the quality management system in their organization. This intensive two-day course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011:2002. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops. | | Future dates | Hayley - Eastwood Hall, Nottingham - 22 November 2010 to 23 November 2010
Hayley - Alexandra House, Swindon - 10 February 2011 to 11 February 2011
Hayley - Cranage Hall, South Manchester 20 June 2011 to 21 June 2011. | | Requirements | Who Should Attend?
- Medical Device Quality professionals with knowledge of quality management systems and ISO 13485
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Managers
- Consultants
Prerequisites: This course does not detail the requirements of ISO 13485:2003.
Prior knowledge of the ISO 13485 standard, such as the overview provided in BSI’s ‘Introduction to ISO 13485 or previous work with ISO 13485 in an organization, is strongly recommended as a prerequisite for this course. | | Funding/fees | £1,070.00+VAT. | | Date(s) | 09/09/2010 to 10/09/2010 |
| Lead Auditor ISO 13485 - (Workshop/Seminar) |
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| BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit program to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions. | | Future dates | Hayley - Eastwood Hall, Nottingham - 6 December 2010 to 10 December 2010
Hayley - Connaught Rooms - London - 14 February 2011 to 18 February 2011 | | Requirements | Who Should Attend?
- Medical Device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Managers
- Engineers
- Consultants
Prerequisites: A prior review of the ISO 13485:2003 standard and internal audit experience are strongly recommended for this course.
| | Funding/Fees | £2345.00+VAT Inc. Accommodation
£1925.00+VAT Excl. Accommodation | | Date(s) | 13/09/2010 to 17/09/2010 |
| Implementing: ISO 13485 - (Workshop/Seminar) |
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BSI’s “Implementing ISO 13485:2003” two day course has been designed to provide participants with the knowledge and process steps to enable them to effectively Implement a quality management system in line with the requirements for ISO 13485:2003 certification.
The course introduces the concepts needed to understand, develop, and implement a quality management system. | | Future dates | Hayley - Eastwood Hall, Nottingham - 18 November 2010 to 19 November 2010
Hayley - Alexandra House, Swindon - 8 February 2011 to 9 February 2011 | | Requirements | Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
Prerequisites: Designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001:2008, or ISO 13485:2003 would be beneficial. | | Funding/Fees | £825.00 + VAT | | Date(s) | 07/09/2010 to 08/09/2010 |
| Medical Devices Risk Management: ISO 14971 - (Workshop/Seminar) |
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This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485:2003.
The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations. Particular focus is on the changes to the 2007 version and how the changes impact the risk management process. | | Future dates | Hayley - Eastwood Hall, Nottingham - 3 December 2010
Hayley - Alexandra House, Swindon - 22 February 2011 | | Requirements | Who Should Attend?
The intended audience for this course includes:
- Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
- Decision makers on management system strategy
- Internal auditors
Prerequisites: Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485:2003. | | Funding/Fees | £530.00 + VAT | | Date(s) | 21/09/2010 |
| Medical Devices CE Marking - (Workshop/Seminar) |
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| BSI’s “Medical Devices CE Marking” three day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course. Participants will gain knowledge of the requirements of the Medical Device Directive and the CE Marking approach. Participants will be able to provide leadership for their organizations when placing medical devices on the market in the European Union | | Future dates | Hayley - Eastwood Hall, Nottingham - 29 November 2010 to 1 December 2010
Hayley - Alexandra House, Swindon - 23 February 2011 to 25 February 2011
Hayley - Cranage Hall, South Manchester 16 May 2011 to 18 May 2011 | | Requirements | Who should attend?
- Regulatory, quality, design, development, manufacturing, marketing managers and personnel
- Organizations preparing ‘own branding’ or ‘private labelling’ of devices
- Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives.
Prerequisites: Participants should have experience with or basic knowledge of quality management systems for the medical device industry or experience of the manufacture, design, marketing or use of medical devices. | | Funding/Fees | £1685.00+VAT. | | Date(s) | 22/09/2010 to 24/09/2010 |
| Introduction to CE Marking - (Workshop/Seminar) |
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| Attend BSI’s “Introduction to CE Marking” one day course and start making informed decisions with regard to meeting the requirements of the EU Medical Devices Directives. On completion of training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly. | | Future dates | Hayley - Alexandra House, Swindon 4 February 2011
Hayley - Cranage Hall, South Manchester 10 May 2011 | | Requirements | Who should attend?
- Senior management
- Regulatory, quality, design, development, manufacturing, marketing managers and personnel.
- Organizations preparing ‘own branding’ or ‘private labelling’ of devices.
Prerequisites: There is no prerequisite from this course but participants will benefit from a basic knowledge of medical device use or manufacture..
| | Funding/Fees | £615.00 + VAT | | Date(s) | 26/11/2010 |
| Introduction to: ISO 13485 - (Workshop/Seminar) |
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| BSI’s “Introduction to: ISO 13485” one day course has been designed to provide an insight in to the use of ISO 13485:2003 as the basis for a quality management system implemented by medical device manufacturers. Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001:2008 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971:2007, “Application of Risk Management to Medical Devices”. | | Future dates | Hayley - Eastwood Hall, Nottingham 17 November 2010
Hayley - Alexandra House, Swindon 7 February 2011 | | Requirements | Who Should Attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the standard
Prerequisites: There is no prerequisite from this course but participants will benefit from a basic knowledge of the quality management systems, ISO 9001:2008 or ISO 13485:2003.
| | Funding/Fees | £385.00 + VAT | | Date(s) | 06/09/2010 |
| Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programmes - (Short Course) |
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This webinar will be highlighting the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercialising products. The course covers a summary review of relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of the methods for effective implementation. Key topics to be discussed include:
* The current regulatory situation in relation to Medical Devices in the EU.
* The purpose and structure of the Medical Device Directives: Standard, Active-Implantables and IVDs.
* Recent Directive updates.
* Meeting the New Requirements for Conformity Assessment by Product Type.
* Understanding the impact the Directive will have on developing and marketing new Medical Device products.
* An overview of key areas of the Directive.
- Scope of application and definition
- EU Classification Rules
- Essential Requirements
- Medical Device Type & Process Path
- Medical Device Technical File
- Clinical Investigations
- Notified Bodies involvement
* Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
Areas Covered in the seminar:
* Definition: Medical Device or Personal Protective Equipment.
* Overview of Global Medical Device Industry / Medical Device Types
- Standard
- Active Implanted
I- n Vitro Diagnostic
- Combined Medicinal / Device- Interface with Other Directives
* An Overview of the Medical Device Directives.
- Development, aims, implementation and update of the Medical Device Directives
- Implication of an EU Directive vs. an EU Regulation
- Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD),
- Combined Medicinal / Medical Device Products
- Update on the additional guidance documents relating to the directives
- Review of Device Essential Requirements
- Classification of MD's and Process Implications / Path by Device Type
- Conformity Assessment Procedure Options
- Technical File / Design History File
- Relationship to EU Clinical Trial Directive
* Guidance Documents.
* Medical Device Directive Annexes.
- Compliance Requirements by Type
- Full Quality Assurance System
- Declaration of Conformity
* Safety.
- Medical Device Vigilance System
- Manufacturer's Requirements
o GMP
o GCP
o CE Marking
o ISO Certification
o Clinical Trials
o Labelling
* ISO Standard Certification.
- Overall process; Management Commitment & Involvement
- Role of Notified Bodies
- Relationship to CE Marking
* ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
* ISO-14155 Medical Device Clinical Investigations.
- Part I- Clinical Studies
- Part II- Clinical Investigations
- Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
* Compare & Contrast EU & FDA Procedures and Requirements.
- Process Similarities & Differences
* Regulatory Approval and Liaison with Regulators.
- Committees, Working Parties Relevant for Medical Devices
- When and How to Influence Regulators
- Do's and Don'ts of Regulatory Involvement
- Individual Company Involvement vs. Trade Association. | | Requirements | This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. | | Funding/fees | £349.00 Access Recorded Version Only - One Person - Unlimited viewing for 6 Months
£600.00 Get Training CD Only - One CD is for usage in one location only. |
| Conducting Medical Device Trials in the EU - (Workshop/Seminar) |
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The EU now includes 25 countries and almost half a billion citizens so there has never been a better time to maximise your product development processes against the competition. This course will help you understand the European clinical trial process for medical devices.
Clinical trials of medical devices are costly, time-consuming and can make or break the fortunes of a company. What's more, European law is a maze of regulations that needs to be navigated with skill and knowledge.
Over 10 weeks, the course provides a comprehensive understanding of EU clinical trials. It explains recently updated regulations, shows you how to choose the best approval route and solves the problem of trial management. You will learn why, when and how to conduct a clinical trial with this guide that takes you through all the stages - from preparation to capitalising on the results. |
| Patent Law and Practice in Medical Devices - (Workshop/Seminar) |
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A practical course for anyone involved in the medical devices industry.
This course will help you know where patent protection fits into your business and how it can arm your company against the competition.
Over 10 weeks, the course provides a comprehensive understanding of the principles of patent law and practice. It shows you how to protect innovative and established medical devices, gives you a thorough grounding in patent filing strategy and solves the problem of intellectual property management.
Created by patent attorney Noël Akers, Patent Law and Practice in Medical Devices gives you unbeatable, convenient training and forms a 10 part reference guide that will serve your company long after you’ve finished. | | Requirements | For medical device specialists
This course will give you a solid understanding of how patent strategies can benefit your business. Learn when the patent filing process should really begin before it’s too late, what is patentable in the medical device field, and how to defend or challenge existing patents. |
| US-FDA Drug Submission Procedures - (Workshop/Seminar) |
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How can you be sure to avoid receiving a FDA non-approvable letter? Do you want to be responsible for delaying your drug submission in the USA because you failed to supply the right registration dossier?
Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA . . . can you afford to waste your R&D investment by delaying your product launch? In the challenging environment of US drug registrations procedures, you and your colleagues need to understand all the current procedures. To help you do this, PTI has developed this course that will clarify the US regulatory process. By attending this extensive two day course, you will be able to gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines. | | Requirements | This course has been specifically designed to address the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers.
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Marketing Managers
- Clinical Research Personnel
- Key contributors to the submission package for the US market | | Date(s) | 09/09/2010 to 10/09/2010 |
| Advanced Toxicology - (Workshop/Seminar) |
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| This practical 3-day training course has been designed to improve the knowledge and understanding of those new to Toxicology and enhance the practices of those still early in their careers. Through interactive sessions and case studies, delegates will gain a greater insight into setting up and running toxicology studies and interpret results. Delegates will also be able to increase their understanding of the vital role of Toxicology in the drug development process. | | Date(s) | 09/11/2010 to 11/11/2010 |
| Photostability Testing: How to perform efficient and compliant photostability programmes for drug substances - (Workshop/Seminar) |
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Methods for determining photostability vary widely and current ICH guidelines can be confusing.
This 2-day interactive workshop will provide a complete insight into photostability and will include interpreting the different terminology, assessing practical aspects of testing, characterising light sources and measuring output.
The programme will demonstrate how to carry out accurate assessments of the tools and techniques required and will highlight the basic rules you need to consider to transfer new methods back to your work place.
| | Requirements | Who Should Attend?
This course is highly recommended for anyone working in pharmaceutical, medical device, biotechnology or biologics companies in the following departments:
• Analytical Development
• Stability
• QA/QC
• Manufacturing/Production
• Validation
• Regulatory Affairs
• GLP/GMP Compliance
• Chemical Engineering
• Research and Development/Chemistry | | Date(s) | 15/09/2010 to 16/09/2010 |
| EU Biosimilar Registration and Marketing Requirements - (Short Course) |
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It has been estimated that by 2010, approximately one-third of all newly approved drugs will be biologics. In-line with this extraordinary expansion, the market for generic versions of biologics – biosimilars – has also become a huge growth area with patent expiration offering companies fresh opportunities to enter a new and highly profitable market.
With the FDA and EMEA approval of the first biosimilar drug in 2007, biosimilars is now a reality. PTI’s interactive 2-day training course will provide delegates with practical solutions on how to gain regulatory approval through fast, compliant registration applications.
| | Date(s) | 08/09/2010 to 09/09/2010 |
| CRO Contracts - (Workshop/Seminar) |
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The perfect outsourcing agreement is based on a long-term commitment where risks and rewards are shared by both sponsor and contract service provider. But how can you reach this equilibrium?
Contract decisions and negotiations are the first vital steps to establishing an effective partnership. Initial agreements will have long term and far reaching consequences for everyone involved in the project.
This practical two-day training course will examine every aspect of the contract process – from choosing the right pricing scheme, through to improving your negotiating skills. Their experienced trainer will encourage flexibility in adopting the best-fit scheme depending on the type of study, and will invite interactivity and discussion. | | Requirements | Directors, Heads, Managers and Team Leaders of:
• Clinical Operations
• Clinical Development
• Clinical Outsourcing
• Contracts
• Project Management
• Finance
• Legal
• Medical Affairs
• Procurement / Purchasing
• Strategic Sourcing / Strategic Planning
• Business Development / Proposal Development / Client Relations | | Date(s) | 06/10/2010 to 07/10/2010 |
| Compliant PIL User Testing - (Workshop/Seminar) |
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Practical solutions on how to file a successful user-tested Patient Information Leaflet in the EU.
Are your Patient Information Leaflets compliant with the latest EU legislation? If not, you face losing valuable time and money having to resubmit your application.
It is crucial that the information presented in your leaflets are accessible and easily understood by the patient so that medicines can be used safely and appropriately.
The pharmaceutical industry must do all they can to enable the users to make safe and accurate decisions about their medicines. Join us for our 2-day practical training course dedicated to the User Testing of the Patient Information Leaflet (PIL) to ensure your User Testing strategy is the best it can possibly be. | | Date(s) | 25/10/2010 to 26/10/2010 |
| CMC Analytical, Comparability and Stability Studies for Biotechnology Products - (Workshop/Seminar) |
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| Providing a step-by-step foundation for biotechnology product stability testing, this comprehensive training course outlines the issues and guidelines surrounding the key elements required for practical and compliant stability programmes. Improve your performance by incorporating new technology and quality control methods for proteins, antibodies, peptides, vaccines, blood products and viral vectors. In-depth details of how to analyse and validate stability indicating methods and their test results will be discussed. | | Requirements | This training course is intended for the professional who is involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:
- Stability Directors/ Supervisors/Managers/Analysts/Coordinators
- Laboratory Supervisors/ Managers
- Project Managers/Coordinators
- Quality Control Analytical Chemists
- Research and Development Chemists
- Biostatisticians
- LIMS Administrators
- QA/QC Reviewers
- Validation Scientists
- Calibration/Metrology Groups
- Internal or Independent Auditors
- Manufacturing/Production Managers | | Date(s) | 14/10/2010 to 15/10/2010 |
| Analytical Data at the Service of QA, Regulatory and Formulation Staff - (Workshop/Seminar) |
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This is a unique 2-day training course designed for all pharmaceutical staff that handle analytical results but have not been trained in analytical chemistry.
The course will explore the fundamental concepts of pharmaceutical analysis allowing regulatory, auditing and quality assurance staff to understand the significance of reported results and identify where errors and inaccuracy may occur.
The course is presented in an easy to understand and practical format without extensive statistical and mathematical treatment. | | Requirements | - Staff who use analytical data but are not trained as analytical chemists
Formulators
- Quality Assurance and Q.P. staff who have not come through the QC route
- Regulatory Staff who handle analytical data in making submissions
| | Date(s) | 03/11/2010 to 04/11/2010 |
| Regulatory Affairs for Biotech - (Workshop/Seminar) |
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The process of drug development is changing rapidly as biotech techniques are becoming more mainstream, and more and more biotech based drugs are coming to market. Regulation of biotech products is fundamentally different from that of NCEs.
Are you fully aware of the extent of these differences and are you confident you have the knowledge you need to work in this field?
This course addresses the issues of real and perceived risks associated with biotech products, and the way the regulatory agencies are dealing with this based on the trainers’ own experiences. This course assumes some knowledge of the science behind biotech.
| | Requirements | Regulatory Affairs
Registration
Compliance
QA/QC
Manufacturing/Production
Product Validation
Process Validation | | Date(s) | 18/11/2010 to 19/11/2010 |
| Practical advice for working with Biocide registrations - (Workshop/Seminar) |
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The course is designed to provide an insight into the BPD and to help individuals gain a better understanding on how this Directive will regulate these types of product in the future. It will provide guidance through a combination of taught sessions and practical exercises on developing data packages, undertaking risk assessments and producing biocides dossiers.
The course will include a number of practical examples and will involve delegates working in teams to navigate the regulatory hurdles presented by the BPD.
| | Requirements | This workshop will be vital for you if you are involved with biocides either as:
Active substance manufacturers, with obligations to submit dossiers or manage dossiers through the evaluation process
Biocidal product formulators who will need to apply for product authorisations
Regulators who want to gain a greater understanding of the use of biocides
Academics with interests in the field of biocides, risk assessments and product approvals.
The workshop will be of interest to:
Project managers
Development managers
Specialists in product and active substance approvals under the BPD
Individuals wishing to branch out from other regulatory areas into biocide approvals
Business managers seeking an overview of product registration issues | | Date(s) | 04/11/2010 to 05/11/2010 |
| Managing Medical Device Software Projects - (Workshop/Seminar) |
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This course forms part of the new Medical Device Training Academy series: Medical Device Training days.
Further information will follow shortly. | | Funding/fees | £450 + VAT
| | Date(s) | 14/10/2010 |
| An Introduction to the Medical Device Directives - (Workshop/Seminar) |
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This seminar provides a detailed introduction to the European medical device legislation. It will explain the directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do, plus the documentation necessary to apply for the CE Mark. This is an excellent introduction from leading experts in the field and delegates should expect two comprehensive days of training.
BENEFITS IN ATTENDING:
Understand the Medical Device Directives
Learn the Role of a Notified Body
Know What a Competent Authority Expects
Hear More on Classification
Better Understand Conformity Assessment Procedures
Comply with Manufacturing Responsibilities
Gain an Insight into Labelling of Devices
Discover Medical Device Vigilance
Consider the Requirements for Quality Systems
Discuss Drug/Device Combinations
Plan Your Clinical Evaluations
Take Away Information on Devices Incorporating Material of Animal Origin
Gain an Overview of the Revision of the Medical Device Directives
| | Requirements | Past delegates include personnel from the following departments: Regulatory Affairs, Pharmacovigilance, Quality Assurance and Technical Support. This seminar will be of interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
| | Funding/Fees | £1200 + VAT | | Date(s) | 16/11/2010 to 17/11/2010 |
| PIPA Forum - Data Protection - (Workshop/Seminar) |
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There will be no charge for attendance for a delegate volunteering to write a report on this forum for PIPELINE. (Limited to one delegate per forum).
Ellis Parry, a qualified solicitor and the Global Privacy Counsel for AstraZeneca, will use this forum to look at the following topics:
An overview of the historical background to the European Union, its aims, ideals and legislative bodies, including in particular an historical assessment of the origins of the Data Protection Directive and the European Convention on Human Rights;
The basics of English data protection law, including a look at what the defined terms mean, how they interrelate, what the eight principles of data protection are and a summary of data subjects' rights.
Building on this theory, Ellis will share an in-depth analysis of the data protection considerations for Medical Information and Pharmacovigilance activities, including topics such as notification, choice, consent, recordings, data retention, data mining and commercial exploitation of the information gathered.
The remainder of the forum will be dedicated to a "Q&A" session where you can pose & discuss particular questions that are pertinent to your working lives. | | Funding/fees | Member Price (inc. VAT): £141.00 | | Date(s) | 07/12/2010 |
| PIPA Forum - Copyright - (Workshop/Seminar) |
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Anyone involved in medical information or pharmacovigilance needs to be aware of copyright and understand how to comply with it. This interactive meeting will clarify the legal requirements, provide practical guidance on compliance and provide a forum for participants to discuss issues of interest to them.
Topics to be covered include:
What copyright means for you
Overview of UK legal requirements and international copyright agreements
Electronic journals
The CLA Digital Pharmaceutical Licence
Open forum: your questions
This forum will be led by Andrew Robson, Consultant | | Funding/Fees | Member Price (inc. VAT): £141.00
| | Date(s) | 22/09/2010 |
| Improving quality and productivity in the NHS: collaboration – research – innovation - (Workshop/Seminar) |
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This important strategy meeting will bring together senior personnel from across the NHS, government, academia, industry and the third sector to debate the key issues and explore solutions to establish UK plc as world class leaders in life sciences.
This event will give all participants the platform to develop new relationships and cement existing ones, ensuring the necessary partnerships are in place to embrace innovation and deliver improved quality and productivity outcomes. | | Date(s) | 11/11/2010 |
| 5th Annual Temperature Controlled Pharmaceutical Distribution - (Conference) |
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The INDUSTRY LED event for all professionals involved with the supply chain of ambient and temperature sensitive pharmaceuticals
Informa LifeSciences’ 5th Annual Temperature Controlled Pharmaceutical Distribution conference will help you uncover the best practices for temperature controlled pharmaceutical distribution to ensure that your products arrive in pristine condition. | | Date(s) | 20/10/2010 to 21/10/2010 |
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