'Investigational medicinal products' presentation slideshows

Minimizing risk by optimizing clinical trial design AGAH Workshop 19 April 2008

Minimizing risk by optimizing clinical trial design AGAH Workshop 19 April 2008. Workshop Minimizing risk by optimizing clinical trial design and performance Wolfgang Timmer, Sybille Baumann. Minimizing risk by optimizing clinical trial design AGAH Workshop 19 April 2008. Overview

662 views • 50 slides

Outline

Outline. General endpoint considerations Surrogate endpoints Composite endpoints Safety outcomes (adverse events). Outline. Some background Definitions Data collection considerations Reporting of safety outcomes Recommendations. Safety Outcomes: Some Viewpoints.

609 views • 48 slides

577 views • 36 slides

Clinical Trial Authorisation in Germany for First-in-Man Trials with NCEs

Clinical Trial Authorisation in Germany for First-in-Man Trials with NCEs. Thomas Sudhop, MD Presented by Christian Steffen, MD Federal Institute for Drugs and Medical Devices (BfArM) Germany. The TeGenero Incident. Trial Design.

581 views • 36 slides