European Medicines Agency public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries

The European Medicines Agency has published a draft 'Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA'.

The document is available on the following webpage:

http://www.ema.europa.eu/Inspections/docs/71239709en.pdf

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European Medicines Agency consultation: Guideline on Procedural advice on the Submission of Variations for Annual Update of Human Influenza Inactivated Vaccines Applications in the Centralised Procedure

The European Medicines Agency has published a Guideline on Procedural advice on the Submission of Variations for Annual Update of Human Influenza Inactivated Vaccines Applications in the Centralised Procedure (EMA/CHMP/BWP/99698/2007 Rev. 1).

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/bwp/9969807en.pdf

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European Medicines Agency consultation: Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

The European Medicines Agency has published a Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture (EMA/CHMP/BWP/68803/2010).

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/bwp/6880310en.pdf

The scope of this draft guideline is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture.

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Committee for Advanced Therapies (CAT) Update

Dear Interested Parties to the Committee for Advanced Therapies (CAT),

As some of you may be aware, at the end of each CAT plenary, the CAT Secretariat drafts a Meeting Report where it disseminates key elements of the work of the CAT. We wanted to make you aware of this document in order to aid you with the attainment of up-to-date information on the decisions made by the CAT. Please click here:

http://www.ema.europa.eu/pressoffice/cat.htm

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Spring Intro Course