PL EN

Aktualności

EMEA: Concept Paper on the Implementation of ICH Q10

25.03.2009
EMEA:
Concept Paper on the Implementation of ICH Q10. This Concept Paper outlines a proposal to implement ICH Q10 (Pharmaceutical Quality System) in the EU (Step 5 of the ICH process). ...

EMEA: The e-submission roadmap of veterinary medicinal products documents

25.03.2009
EMEA:
The e-submission roadmap of veterinary medicinal products documents. The initiative to create a veterinary sub-group of the Telematics Implementation Group on electronic submission ...

EMEA: 2008 public status report on the implementation of the European Risk Management Strategy

25.03.2009
EMEA:
2008 public status report on the implementation of the European Risk Management Strategy. The European Risk Management Strategy (ERMS) is a joint EMEA – Heads of Medicines ...

EMEA: Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products

25.03.2009
EMEA:
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products. The aim of this guideline is to provide guidance regarding study design, conduct and ...

EMEA: Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)

25.03.2009
EMEA:
Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD). This ...

EMEA: Corrected Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework

25.03.2009
EMEA:
Corrected Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. This paper describes and define the different guidelines that ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

EMEA: Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs

25.03.2009
EMEA:
Revised HMPC procedure on management of proposals from interested parties for Community list entries or Community herbal monographs. The purpose of this document is to streamline and ...

MHRA: Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)

25.03.2009
MHRA:
Updated guidance for Marketing Authorisation applications for medicines using the Decentralised procedure with the UK as Reference Member State (RMS)
MHRA have revised and ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny