When: 31 Jan -2 Feb 2018
Where: De Vere Latimer Estate, Chesham, UK
What is it?
Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements for carrying out clinical research, including the latest requirements for IMPD preparation and good distribution practice, ethical and regulatory approval, clinical trials with medical devices and ISO14155, good clinical practice standards, preparation of clinical trial reports, the more demanding requirements of pharmacovigilance and also the legal aspects relevant to clinical trials such as data protection, insurance and codes of practice.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.
- Students will understand the practical aspects of Good Clinical Practice and how it supports clinical research.
- Students will be able to identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and the requirements and practicalities of preparing the required clinical trial applications and associated documentation.
- Students will gain an insight into the complexities and requirements of pharmacovigilance in clinical research.
- Students will be able to understand the management of clinical trial supplies.
- Students will be able to understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products.
- Students will be able to understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections.
- Students will gain an appreciation of the legal and ethical aspects of clinical research, including insurance, indemnity and the role of the ethics committees and safety boards.
Outline of module topics:
- Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) and other clinical dossier requirements including the progression of clinical trials in relation to the toxicity programme.
- Ethics Committees and Safety Boards.
- Clinical trial labelling, supplies management and Good Manufacturing Practice requirements
- Pharmacovigilance of clinical trials.
- Clinical trial reports.
- Data management.
- Good Clinical Practice – Inspections, data auditing and compliance with the Declaration of Helsinki.
- Compassionate use/extended access.
- The legal aspects of clinical trials.
Who is it for?
This module is designed for professionals in regulatory affairs to develop and deepen their understanding of all aspects of the regulation of clinical operations. It will allow them to examine the regulatory requirements imposed on clinical research, the processes of preparing documentation for clinical trial authorisation and the ethical and legal considerations. In particular the module will impart the ability to critically appraise actions and report recommendations on the appropriateness of strategies in clinical research.
How do I apply?
A limited number of discounted places are available for those working in regulatory agencies, government bodies, charities or patient groups . Please email us for a discount code before making your booking.
Travel and accommodation is not included. You will receive information on how to book accommodation and special rates once you have booked onto the course. The special bed and breakfast rate is £99.00 plus VAT per night.
The discounted rate is limited to six weeks prior to the start of the module and may change subject to availability, so please ensure you book as soon as possible.