News
EMEA: Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1
28.02.2009
EMEA:
Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1.
This ...
Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1.
This ...
EMEA: Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder
28.02.2009
EMEA:
Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder.
It is aimed that the Guideline on the development of new products for the ...
Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder.
It is aimed that the Guideline on the development of new products for the ...
EMEA: Guideline on clinical development of fixed combination medicinal products
28.02.2009
EMEA:
Guideline on clinical development of fixed combination medicinal products.
This guideline covers fixed combination medicinal products containing two or more active substances, ...
Guideline on clinical development of fixed combination medicinal products.
This guideline covers fixed combination medicinal products containing two or more active substances, ...
EMEA: Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive pulmonary disease (copd)
28.02.2009
EMEA:
Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive ...
Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive ...
EMEA: Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections
28.02.2009
EMEA:
Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections.
This Concept Paper ...
Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections.
This Concept Paper ...
EMEA: Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease
28.02.2009
EMEA:
Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease. Introducing a new guideline in a field where no such ...
Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease. Introducing a new guideline in a field where no such ...
EMEA: Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population
28.02.2009
EMEA:
Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population. This reflection paper, reflecting experience from recent ...
Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population. This reflection paper, reflecting experience from recent ...
EMEA: Guideline on Xenogeneic Cell-based medicinal products
28.02.2009
EMEA:
Guideline on Xenogeneic Cell-based medicinal products. This Guideline addresses the scientific requirements for xenogeneic cell-based medicinal products for human use. ...
Guideline on Xenogeneic Cell-based medicinal products. This Guideline addresses the scientific requirements for xenogeneic cell-based medicinal products for human use. ...
EMEA: Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs)
28.02.2009
EMEA:
Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs). Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU. ...
Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs). Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU. ...
EMEA: Updated EMEA Post-Authorisation Procedural Advice Guidance
28.02.2009
EMEA:
Updated EMEA Post-Authorisation Procedural Advice Guidance. Questions & Answers ...
Updated EMEA Post-Authorisation Procedural Advice Guidance. Questions & Answers ...