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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 ...

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 ...

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 ...

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 ...

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. ...

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. ...

EMEA: Updated EMEA Post-Authorisation Procedural Advice Guidance

28.02.2009
EMEA:
Updated EMEA Post-Authorisation Procedural Advice Guidance. Questions & Answers ...

EMEA: Appendix II of Quality Review of Documents (QRD)

28.02.2009
EMEA:
Appendix II of Quality Review of Documents (QRD). Translation of the MedDRA terminology for frequencies and system organ classes to be used in SPC Section 4.8 \"Undesirable effects\" ...

EMEA: Calls for submission of scientific data relating to the assessment of: Prunus spinosa L.

28.02.2009
EMEA:
Calls for submission of scientific data relating to the assessment of: Prunus spinosa L.
The HMPC invites all interested parties1 to submit any scientific data, which may be ...

EMEA: Calls for submission of scientific data relating to the assessment of: Cichorium intybus L.

28.02.2009
EMEA:
Calls for submission of scientific data relating to the assessment of: Cichorium intybus L.
The HMPC invites all interested parties1 to submit any scientific data, which may ...