The European Medicines Agency has released for public consultation a 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'.
The current guideline mainly focuses on non-clinical aspects of drug development
and the use of animal data and reflects the practice at the time it was developed which
focused on a single ascending dose (SAD) design for first-in-human (FIH) trials.
Since then, integration of the non-clinical data available before FIH administrations and
the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging
during a trial has also evolved. Consequently, the practice has evolved and many FIH
trials are now performed with integrated protocols potentially combining a number of
different study parts, e.g. single and multiple ascending doses (SAD and MAD), food
interaction, different age groups and early proof of concept or early proof of principle
parts. FIH and early phase CTs with multiple study parts are, therefore, increasingly
being submitted for regulatory review to National Competent Authorities as part of a
single CT application.
The document open for consultation is available by clicking here:
http://www.ema.europa.eu/ema/doc_index.jsp? curl=pages/includes/document/document_detail.jsp? webContentId=WC500210825&murl=menus/document_library/document_library.jsp&mi d=0b01ac058009a3dc
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We would like to draw your attention to the publication of the European Commission
call for expression of interest related to the appointment of alternates representing
clinicians at the Committee for Advanced Therapies (CAT) of the European Medicines
Expressions of interest must be submitted to the European Commission by 30
September 2016 at the following address: SANTE-CONSULT-