| 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 |
| 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 |
| Introducing GMP Training - (Workshop/Seminar) |
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| To provide a basic knowledge of the importance of following current Good Manufacturing Practice. | | Future dates | * 26th October 2010, Dublin, Ireland, £420+VAT per learner (£483 inc. VAT).
* 23rd November 2010, London, £420+VAT per learner (£483 inc. VAT). | | Funding/fees | £399+VAT per learner (£458.85 inc. VAT).
| | Date(s) | 28/09/2010 |
| How to write SOPs Training - (Workshop/Seminar) |
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To provide the learners with the fundamental skills and knowledge to create effective SOPs.
| | Future dates | * 23rd November 2010, Glasgow, £399+VAT per learner (£458.85 inc. VAT). | | Funding/Fees | £430+VAT per learner (£505.25 inc. VAT). | | Date(s) | 14/09/2010 |
| Good Manufacturing Practice (GMP) Fast Track Freshers Training Programme - (Workshop/Seminar) |
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| To provide a basic knowledge of the importance of following current Good Manufacturing Practice. | | Future dates | * 26th - 28th October 2010, Dublin, Ireland
* 23rd - 25th November 2010, London
* 25th - 27th January 2011, Glasgow
* 22nd - 24th February 2011, Manchester
* 26th - 28th April 2011, London
* 24th - 26th May 2011, Cork, Ireland
* 21st - 23rd June 2011, Manchester
* 26th - 28th July 2011, London
* 27th - 29th September 2011, Edinburgh
* 25th - 27th October 2011, Dublin, Ireland
* 22nd - 24th November 2011, London. | | Funding/Fees | £1195+VAT per learner (£1404.13 inc. VAT). | | Date(s) | 05/10/2010 to 07/10/2010 |
| 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 |
| 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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| 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. | | Additional Information | CPD Points: 10 | | Date(s) | 09/11/2010 |
| Process Mapping as a Management and Auditing Tool - (Workshop/Seminar) |
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| This course has been designed to make you a confident process mapper. You will be able to apply this new skill to describe and communicate processes and use mapping as a process improvement tool. If you are involved in writing standard operating procedures or protocols, managing their implementation, planning or conducting process audits, generating or utilising process performance metrics, solving problems and continual process improvement, this is the course for you. The course is designed for all those with responsibility for managing, documenting, implementing or auditing projects, processes and procedures. | | Future dates | 7th - 8th December 2010 | | Funding/fees | Association Members £750 inc VAT
Non Members £910 inc VAT | | Date(s) | 07/12/2010 to 08/12/2010 |
| Effective Monitoring Visits - (Workshop/Seminar) |
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| What every monitor should know to be able to comply with the regulatory requirements for carrying out effective monitoring visits. | | Funding/fees | £1,290.00 | | Date(s) | 15/11/2010 to 16/11/2010 |
| Valid Informed Consent - (Workshop/Seminar) |
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• To introduce researchers to the concept of Valid Informed Consent
• To outline the valid informed consent process
• To understand responsibilities in the consent process
• To understand GCP requirement in the consent process
• To understand the EU Directive requirement for a prior interview
Content Outline:
This seminar is designed to give researchers an understanding of the valid informed consent process.
To examine current practice against GCP EU Directive requirements.
Its aim is to outline the process and identify roles and responsibilities within that process.
To examine the need for Standard Operating Procedures for consent to ensure uniformity of practice.
The seminar comprises of power point presentations and group work activities.
It is recommended for anyone new to research or anyone wishing to consolidate existing knowledge would benefit from attending this module | | Requirements | This course would be suitable for:
Any new member of the multi-disciplinary team involved with Patients who are involved in a Research, Study or Clinical Trial. | | Date(s) | 24/11/2010 |
| Essential Guide To Pharmacovigilance - (Short Course) |
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Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for Companies to perform various duties regarding the safety of their products to satisfy regulatory demands. Regulatory Authorities are visiting all licence holders to perform inspections on a Companies compliance to Pharmacovigilance and the visits can also include visiting marketing partners as well (even outside the EU) and the sanctions that exist for those Companies who do not look after the safety of their products are severe and could result in licence withdrawal.
This course has been designed to simply explain what Companies need to be aware of in terms of their responsibilities and what they need to do to avoid regulatory action. Can you afford not to know?
Topics to be covered will include:
* An Introduction to EU Pharmacovigilance
* Documentation to be Supplied to Regulatory Authorities
* Department Links in the Company to Pharmacovigilance
* Licensing Partners and Pharmacovigilance
* The Role of the Qualified Person for Pharmacovigilance
* Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
* Pharmacovigilance Inspections. | | Requirements | This course will be relevant for anyone requiring a concise overview of the Pharmacovigiliance function. It may also be of particular interest to those who are new to Pharmacovigilance or who work with pharmacovigilance, eg Regulatory Affairs, Sales & Marketing, Legal, Commercial and Quality. | | Date(s) | 04/10/2010 |
| How To Write SOP's - (Short Course) |
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SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to use by the end-users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non compliance issues which could lead to delays in bringing a drug/device to market.
This SOP course has been specifically designed to help you develop the skills to write, produce the content of SOPs, review and implement SOPs and in particular to be able to comply in a regulated environment. It is essential therefore to have a number of SOPs, and for existing SOPs to be reviewed and updated regularly. Otherwise this is likely to result in major findings by regulatory inspectors. Participants will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users. | | Date(s) | 31/01/2011 |
| Writing SOPS - a Workshop - (Workshop/Seminar) |
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The workshop is organised to enable participants to understand the information a SOP should contain.
At end of the workshop participants will be able to:-
• Write a SOPs action list
• Appreciate the need for review and document control
• Write a SOP
Content Outline:
The workshop involves group activity around the writing/approval/circulation and implementation of Standard Operating Procedures.
A short power point presentation outlining content requirements, followed by workshops involving
SOPs action list
SOP design
Peer review
Document tracking
Circulation and implementation. | | Requirements | This course would be suitable for: Any one involved in writing Standard Operating Procedures. | | Date(s) | 14/12/2010 |
| Clinical Research Associate (CRA) Training Practical - (Short Course) |
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| This module will provide you with the knowledge and skills to be able to critically appraise the practical aspects of the Clinical Research Assistant (CRA) role and to apply this knowledge to enhance your ability to improve your practice as a CRA within a large Clinical Research Organisation. |
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