Political meeting

The Clinical trials facilitation group (CTFG)

Other meetings
Venue
Radisson Blu "Latvija" Hotel
Elizabetes iela 55, Rīga LV-1010, Latvia
Event dates
June 16 - June 17

Last updated on 16 June 2015, 12.46

The Heads of Medicines Agencies (HMA) agreed to establish a Clinical Trials Facilitation Group (CTFG) in 2004. The initial aim of the CTFG was to coordinate the implementation of the Clinical Trials Directive (Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001) across the Member States. The further CTFG activities are related to the development of common principles and procedures for clinical trials evaluation and authorisation in Europe.

The agenda of the Meeting of the CTFG includes issues related to the implementation of the Regulation (EU) 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use in EU Member States: development of a common European clinical trials web portal, establishment of the criteria for selection of the Reference State during the clinical trials evaluation process, development of the final clinical trials evaluation report form, safety information harmonised assessment, improvement of the Voluntary Harmonisation Procedure and operation of the National Ethics Committees.

The Meeting of the CTFG brings together the clinical trials experts of the European medicines agencies, as well as the representatives of the European Medicines Agency.

More information about the CTFG: http://www.hma.eu/ctfg.html.

 

Contacts
Egita Diure
State Agency of Medicines of the Republic of Latvia
Public Relations Specialist
+371 25400181
+371 67078422