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European Commission: EudraLex Volume 10 - Clinical trials guidelines

29.07.2009
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

29.07.2009
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

29.07.2009
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

27.07.2009
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

27.07.2009
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

27.07.2009
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

27.07.2009
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

27.07.2009
Finalised documents for the community herbal monograph on Althaeae radix Althaea officinalis L., radix (marshmallow root) ...

EMEA: EMEA PCWP and HCP WG report on information on benefit-risk of medicines: patients' consumers' and healthcare professionals' expectations

27.07.2009
The present document addresses the communication aspect in the light of society’s need for transparent information on the benefits and risks of medicines. It has been prepared in association ...

EMEA: CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009)

27.07.2009
This document applies to the pharmacovigilance plan as part of the risk management plan introduced with the authorisation application of mock-up pandemic influenza vaccines according to the CHMP ...

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