Clinical Trials Facilitation Group
Introduction
EU Heads of Medicines Agency (HMA) agreed in 2004 to establish a clinical trials facilitation group (CTFG) to co ordinate implementation of the EU clinical trials directive 2001/20 EC across the member states.
In relation to clincial trials the CTFG acts as forum for discussion to agree on common principles and processes to be applied throughout the European medicines regulatory network (EMRN).
It also promotes harmonisation of clinical trial assessment decisions and administrative processes across the national competent authorities (NCA).
CTFG members and representatives
The CTFG is attended by representatives from the NCA’s, European Commission and the European Medicines Agency.
CTFG is currently chaired by Dr Harmut Krafft (PEI), the co chair is Dr Chantal Belorgey (AFSSAPS) and the secretariat for the group is Anna Lenaers (fagg-afmps).
CTFG Mandate
CTFG received a new mandate and terms of reference from HMA this was adopted on the 4/1/08.
The main priorities and functions of CTFG will be
- Sharing of scientific assessments
- Harmonise processes and decisions
- Participate in development of information systems
- Communication
- Co operation with other working groups.
CTFG Workplan
In order the achieve and implement this mandate CTFG has drafted a work plan for 2008-2009 (link)
The CTFG has the following work plan ambitions and aims for the next 2 years
- Sharing of scientific assessment of multinational clinical trials
- Harmonising processes and practices relating to clinical trials mainly in the fields of clinical trial applications(CTA), clinical trial amendments and safety procedures.
- Developing data sharing and particating in the improvement of information systems
- Developing communication with stakeholders and co-operating with other EU working groups