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EMA: Concept paper on Revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release

17.11.2011
Annex 16 of the Guide to Good Manufacturing Practice for Medicinal Products gives guidance on the certification and batch release of medicinal products within the European Union and European ...

GMP: MHRA announces Good Clinical Practice (GCP) Discussion Forum

17.11.2011
The U.K. Medicines and Healthcare products Regulatory Agency MHRA has created a GCP Discussion Forum to help all those involved in the conduct of clinical trials implement quality procedures that ...

EMA: Concept Paper on the Update of Guidance on the Clinical Development of Medicinal Products for the Treatment of HIV

17.11.2011
The present EMA guidance was adopted in 2008. The main circumstance prompting the need for updated guidelines is the changing landscape of HIV treatment following the licensing of new treatment ...

GMP: European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

17.11.2011
Last year, the European Medicines Agency (EMA) announced in a \"Concept Paper\" that they would revise their Note for Guidance on Process Validation from 2001 and focus on the product lifecycle. ...

EMA: Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities

02.11.2011
The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a ...

GMP: FDA publishes List of Guidance Documents for Medical Devices

02.11.2011
The FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development in the fiscal year 2012 (October 2011- ...

FDA: Q8, Q9, and Q10 Questions and Answers

02.11.2011
Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) ...

EMA: Concept paper on the need for revision of the position paper on indications for veterinary vaccines

02.11.2011
The revised position paper on indications for veterinary vaccine (EMEA/CVMP/042/97-Rev.1-FINAL) was adopted by the CVMP in June 2003. This paper presents the standard statements that should be ...

EMA: ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification

02.11.2011
This document is a guide for implementing ICH1 requirements for the electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This ...

GMP: FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

20.10.2011
The U.S Food and Drug Administration (FDA) released 8 new draft proposals in a report titled \"Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase ...

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