Investigational medicinal product dossier
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INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR …
cdsco.nic.inC:\Users\website\Desktop\pendency july\IMPD Template Quality.doc Last printed 8/18/2016 8:02:00 PM INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR
2009 06 annex13 - ECA Academy
academy.gmp-compliance.orgComparator product An investigational or marketed product (i.e. active control), or placebo, used as a reference in a clinical trial. Investigational medicinal product
1 2) ガイドラインアネックス 13 和訳
ecompliance.co.jp別紙（1 2) PIC/S GMPガイドラインアネックス13 原文 和訳 MANUFACTURE OF INVESTIGATIONAL 治験薬の製造 MEDICINAL PRODUCTS lnvestigational medicinal products should be 治験薬は医薬品GMPの原員lj と詳細ガイドフインを遵 produced in accordance with the principles and the 守して製造すること。
European Medicines Agency Inspections
ec.europa.euguideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
EU GMP Requirements
www.ema.europa.euTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker 3 Trade & Industry Inspection Agency of Lower Saxony / Germany, Hannover office Contents covered Legislation related to Investigational Medicinal …
OECD Recommendation on the Governance of Clinical Trials
www.oecd.orgC – New product B – Modified use A – Usual care Ethical review Approval consent Approval consent Approval consent Regulatory bodies Approval Approval (trial specific provisions for content of dossier) Approval may not be
The new Clinical Trial Regulation and corresponding new EU ...
dgra.deCAP Centrally Authorised Product . CEN Comité Européen de Normalisation, European Committee for Standardisation . CENELEC Comité Européen de Normalisation Électrotechnique, European Committee for
National Drug Authority Guidelines - World Health …
apps.who.intNational Drug Authority Guidelines for the conduct of clinical trials NATIONAL DRUG AUTHORITY MINISTRY OF HEALTH
Current Global GMP Status and Trends With Focus on EU & …
www.jpma.or.jpCurrent Global GMP Status and Trends With Focus on EU & PIC/S JPMA Annual Meeting, Tokyo & Osaka, September 2012 Dr.-Ing. Stephan Rönninger Pharma Medicines Technical Operations Global Quality & Compliance , F. Hoffmann-La Roche Ltd
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INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR, 2009 06 annex13, Product, INVESTIGATIONAL, Investigational medicinal product, Medicinal, European Medicines Agency Inspections, Investigational Medicinal, EU GMP Requirements, OECD Recommendation on the Governance of, Dossier, NATIONAL DRUG AUTHORITY, Current Global GMP Status and Trends