Sept2015 BoardMeeting Agenda Item 13f – clinicaltrials&EMA

Francesca Venturini continues to represent EAHP in respect of EMA developments in the area of clinical trials (e.g. implementation of the 2014 clinical trials regulation). 

 

To also be aware of 2 current Commission consultations on GMP and IMPs, and clinical trial inspection procedures. More information here.

 

In respect of the ongoing Alltrials campaign, news over the summer includes:

• 85 pension funds and asset managers express support for AllTrials campaign;
• AllTrials USA launches

 

RF and JP attended the recent EMA Healthcare Professionals Working Group 17-18 September 2015. Table of actions from that meeting here.

 

There are no currently identified EMA consultations of key interest to EAHP at the current time.

 

EAHP will present to the EMA workshop on medicines shortages, as reported in agenda item 7c.

 

Over the summer EMA advertised vacancies for its PRAC and CAT committees, which were promoted via the EU Monitor and EAHP social media channels. 

 

The EMA has announced a workshop on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products to which expressions of interest in attending are invited by 2nd October. More information here.

 

An EMA workshop on orphan drugs on 7 December will be attended by Marc Dooms.