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EMEA: Guideline on the development of New Products for the Treatment of Nicotine Dependence

30.01.2009
EMEA:
Guideline on the development of New Products for the Treatment of Nicotine Dependence. The present document is to provide guidance in the definition of treatment goals, study design, ...

EMEA: Draft guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

30.01.2009
EMEA:
Draft guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension. The main focus of this guideline is pulmonary arterial ...

EMEA: Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods

30.01.2009
EMEA:
Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. The new guideline will provide recommendations for the validation of a ...

EMEA: Guideline on development, production, characterization and specifications for monoclonal antibodies and related products

30.01.2009
EMEA:
Guideline on development, production, characterization and specifications for monoclonal antibodies and related products. This guideline addresses quality issues for the marketing ...

EDQM: Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium

30.01.2009
EDQM:
Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium
The purpose of this document is to provide to all users of the European Pharmacopoeia ...

European Commission: Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”

30.01.2009
European Commission:
Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”. It applies to medicinal products ...

MHRA: Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations

30.01.2009
MHRA:
Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations. There is currently a global ...

EMEA: COMP Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation

30.01.2009
EMEA:
Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation ...

EMEA: List of questions & answers (Q&A) received during the HMPC assessors training on quality issues emerging for herbal medicinal products

30.01.2009
EMEA:
List of questions & answers (Q&A) received during the Committee on Herbal Medicinal products (HMPC) assessors training on quality issues emerging for herbal medicinal products (held ...

EMEA: Draft EudraVigilance access policy for medicines for Veterinary use

30.01.2009
EMEA:
Draft EudraVigilance access policy for medicines for Veterinary use. This document should serve as a starting point for the elaboration of EudraVigilance access policies and the ...

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