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EMEA: New European Medicines Agency standard operating procedure. Performing duplicate detection

18.03.2010
The purpose of duplicate detection is to eliminate duplicate ICSRs from the EudraVigilance system, to ensure that the calculations and analyses performed on data in the EudraVigilance system will ...

EMEA: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

18.03.2010
This guideline outlines the requirements for data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing ...

EMEA: Guideline on the development of medicinal products for the treatment of alcohol dependence

04.03.2010
The aim of this guideline is to provide guidance for clinical studies for drugs developed for the treatment of alcohol dependence ...

EMEA: Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on Haematological malignancies

04.03.2010
The aim of this appendix is to provide guidance on the design of confirmatory in patients with haematological malignancies. ...

EMEA: Draft guideline on Real time Release Testing (formerly Parametric Release) for external consultation

04.03.2010
This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR ...

EMEA: Organization of Heads of Unit meetings

26.02.2010
This Standard Operating Group Procedure describes the organization of Heads of Unit meetings and the preparation of meeting documents. ...

EMEA: Overview of comments to the guideline on the investigation of bioequivalence

26.02.2010
Overview of comments received on draft guideline CPMP/EWP/QWP/1401/98 rev.1 has been published. All comments have been gathered on 248 pages. The document contains explanations for all the changes ...

EMEA: Draft Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus

26.02.2010
This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with diabetes. ...