Clinical Trial Authorisation Framework In Europe Overview

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Clinical trial authorisation framework in Europe - overview

www.ema.europa.eu

1 Clinical trial authorisation framework in Europe - overview Dr Chantal Bélorgey Head, CTs Department, Afssaps, France. Chair of CTFG. EMA – SME meeting 28 May 2010

Clinical, Framework, Overview, Trail, Europe, Authorisation, Clinical trial authorisation framework in europe overview

Regulatory Toxicology - Society of Toxicology

www.toxicology.org

Overview/Objectives ... Duration of Repeat Dose Toxicology Studies Depends on Clinical Trial Duration . ICH M3 (R2) Non -Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals (2009) Industrial chemicals: Driven by production volume/import tonnage (ECHA 2014)

Regulatory, Clinical, Overview, Trail, Clinical trials, Authorisation

Labelling Requirements for Investigational Medicinal ...

www.dgra.de

• Clinical Trial • Multicentre Clinical Trial • Investigational Medicinal Product • Sponsor These definitions are given in the ICH-guideline (E6) for GCP. Their implementation differs only slightly in the European Union (EU), Japan (JP) and the United States (US).

Clinical, Trail, Clinical trials

Clinical Trial Authorisation Framework In Europe Overview