Aktualności
MHRA: Updated guidance on changes to labelling and patient information leaflets for self certification
30.01.2009
MHRA:
Updated guidance on changes to labelling and patient information leaflets for self certification. This document sets out the circumstances under which changes to the labeling and ...
Updated guidance on changes to labelling and patient information leaflets for self certification. This document sets out the circumstances under which changes to the labeling and ...
EMEA: Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
30.01.2009
EMEA:
Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD). This Guideline is intended to assist applicants ...
Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD). This Guideline is intended to assist applicants ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation ...
