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EMEA: ICH M 2 Questions and Answers - Common Technical Documents for the Registration of Pharmaceuticals for Human Use

29.06.2009
This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common ...

EMEA: ICH M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

29.06.2009
The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope ...

EMEA: ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Qualit Risk Management Pharmaceutical Quality System Questions and Answers

29.06.2009
This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering ...

EMEA: ICH Q 4 B Annex 5 to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter

29.06.2009
This annex is the result of the Q4B process for Disintegration Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

EMEA: ICH Q 4 B Annex 8 to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on sterility test general chapter

29.06.2009
This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

EMEA: ICH Q4B Annex 9 Step 3 Tablet Friability General Chapter

29.06.2009
This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

EMEA: ICH Q 4 B Annex 10 Step 3 Polyacrylamide Gel Electrophoresis

29.06.2009
This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

European Commission: Notice to Applicants, Volume 6C Guidance on the Assessment of environmental risks of veterinary medicinal products

29.06.2009
Notice to Applicants, Volume 6C, new guidance document as regards the assessment of environmental risks of veterinary medicinal products resulting from amending Directive 2004/28/EC to Directive ...

EMEA: Draft guideline on the clinical evaluation of anti-fungal agents for the treatment and prophylaxis invasive fungal disease

26.06.2009
The guideline is primarily concerned with the content of clinical development programmes to assess the safety and efficacy of antifungal agents administered by oral or parenteral routes for the ...

EMEA: Reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products

26.06.2009
This document defines the scope, content and format of the documents to be published by EMEA in connection with the withdrawal of an application for a centralised veterinary product by ...

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