European legislation is often far away from daily routine in clinical trials, yet during this course you receive all necessary information in a very practical way. You get the ins and outs of several legislations, such as the clinical trial directives, showing the consequences for you. After this course, European legislation will hold no more secrets for you!
This one-day course is designed to provide a clear understanding of the current regulatory requirements for Clinical Trials with investigational medicinal products in Europe.
Essentials of the current European Directives
2001/20/EC, 2005/28/EC and the Voluntary Harmonisation Procedure (VHP) are
explained. Current requirements for submission and approval procedures of
clinical trial applications, safety reporting, substantial amendments, and the
publication of trial results are explained. You will learn about non-commercial
and post-authorisation safety trials. The state-of-the-art regarding
implementation and implications will be presented. Much attention of the course
goes to the implementation of legislative requirements and guidance documents in practice.
In addition, the European Clinical Trial Regulation 536/2014 which will be the future legislative obligatory requirements is outlined. And finally, an overview updates you on other legislations with topics related to clinical research.
Course time09:00 - 17:00
Who should attend
Everyone involved in clinical
research including: pharmaceutical companies, Contract Research Organisations
(CROs), investigators, site personnel and ethics committee members.
People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
- Review of key areas of the directives and implementing European legislative texts
- Clinical trial authorisation from ethics committees and authorities
- Substantial Amendments and Safety reporting
- Post-Authorisation Safety studies
- Voluntary Harmonisation Procedure
- Outline of the Clinical Trial Regulation 536/2014