EMEA: Consolidated EMEA decision on the list of class waivers 2009

The Paediatric Committee of the European Medicines Agency has given, a positive opinion of its own motion for a review of a class waiver on condition(s), ...

European Commission: Publication of summaries of Community Decisions on marketing authorizations

The Commission publishes, in the Official Journal of the European Union, summaries of Community Decisions on marketing authorisations. These summaries are usually published on the last Friday of ...

European Commission: EudraLex Volume 10 - Clinical trials guidelines

The \"Questions and Answers document\" in the EudraLex volume 10 on clinical trials has been revised. ...

European Commission: Contribution submitted in response to the Public Consultation Paper on a Contribution for a future Commission regulation on the format and content for applications and requests for an opinion on a maximum residue limit for a pharmacol

From 11 May 2009 till 6 July 2009 the Directorate General for Enterprise and Industry invited stakeholders to comment on a contribution to the preparation of a future Commission regulation on the ...

MHRA: MHRA exercise to update product information following European paediatric work-sharing procedures

Following the announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing fluvastatin where product information has not already ...

EMEA: Concept paper on the need to revise the guideline on the use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use

The current guideline was prepared at a time when the scientific possibilities for transgenic animals were being investigated and no product had been generated for commercial or clinical trial ...

EMEA: Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines

In 2002 the Biotechnology Working Party at the EMEA began drafting guidance on the product information (summaries of product characteristics, labelling and patient leaflets) for human ...

EMEA: Revision of Happendix II “Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC

Revision of Happendix II “Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC Section 4.8 \"Undesirable effects\": minor changes in Italian, Maltese ...

EMEA: Adopted guideline on the Investigation of Medicinal Products in the Term and Preterm Neonates

This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this ...

EMEA: Community herbal monograph on Althaeae radix

Finalised documents for the community herbal monograph on Althaeae radix Althaea officinalis L., radix (marshmallow root) ...

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