The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
September Board agenda item 14f. Clinical trials and EMA issues
Link back to September 2016 Board Meeting agenda here.
Clinical Trials
Over the summer EAHP submitted responses to 4 consultations by the European Commission on clinical trial regulation issues.
Consultation | Response | Key Points |
Layperson summaries | here |
– Supported layperson summary concept – Promoted strengthened wording |
Auxiliary products | here | – Promoted strengthened wording |
here |
– Promoted role of hospital pharmacist (e.g. in determining formulations) – Recommended strengthening of words – Emphasised importance of the child’s consent |
|
Risk proportionate approaches | here |
– Suggested marketing authorisation in another country also be included as “published scientific evidence”. – Proposed strengthened wording across the guidance document |
Currently open consultations relating to clinical trials:
Meanwhile, the AllTrials campaign continues to make progress with recent positive developments at both the UN level, and within the United States. More information here and here.
EMA matters
To consider forthcoming EMA workshops.
RF report of EMA Pharmacovigilance event here.
Verbal feedback from September 2016 meeting of the EMA healthcare professional working party and social media workshop.