Critical Compliance and Major Changes for the EU Clinical Trials Directive

Why Should You Attend:

This presentation will discuss the key requirements of the European Clinical Trials Directive 2001/20/EC and the important proposed changes.

This presentation will explain the framework of documents, provided in the Clinical Trials Directive, which sets out how clinical trials must be conducted. We will discuss how the Directive was further expanded by Commission Directive 2005/28/EC of laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice - " the GCP Directive").

This presentation will also discuss in what ways the Clinical Trials Directive is currently undergoing a major consultation process to try to overcome some of the key challenges of working to the Directive.

Areas Covered in the Seminar:

• What are the requirements of the Clinical Trial Directive for setting up and running clinical trials?
• Understanding the framework of key guidelines and documents which cover the detail of the Clinical Trials Directive requirements.
• What are the challenges and issues of working to the Directive and what are the options being considered to overcome these issues?
• What is the likely response to the 2011 consultation process to manage the problem areas of the Directive?
• What are the options being considered for improving clinical trial application authorization?
• What are the implications for inspection?

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials for pharmaceutical, and biopharmaceuticals

• Clinical Development managers and personnel
• Clinical research associates
• Clinical Research archiving and document management personnel
• Quality assurance managers and auditors
• Clinical Development managers and personnel
• Consultants
• Regulatory Affairs Specialists
• Pharmacovigilance /drug safety

Instructor Profile:

Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 17 years experience of running clinical trials and clinical quality assurance in the pharmaceutical industry. She has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Laura is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is author of SCRIP's latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GCP issues.

Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP , the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.

Topic Background:

The European Clinical Trials Directive 2001/20/EC was introduced to establish standardization of research activity in clinical trials throughout the European Community. The Directive was transposed into laws throughout the EU from 1st May 2004 and is going through possible major changes currently.

Clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive. Also, if the clinical trials are conducted outside the EU, but submitted in an application for marketing authorization in the EU, they should have to follow the principles which are equivalent to the provisions of the Clinical Trials Directive (cf. Annex I, point 8 of the " Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use" - " the Community Code for medicinal products ").

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