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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

Ethical considerations trials with minors

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:

Consultation Deadline
EMA concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ Deadline 30th September
Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials Deadline 12th October
Implementation of the Second European and Developing Countries Clinical Trials Partnership Programme Deadline 15th October 
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials Deadline 31st December

 

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.

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.