PSI Statisticians in the Pharmaceutical Industry GUIDELINES FOR STANDARD OPERATING PROCEDURES for Good Statistical Practice in Clinical Research Written by: PSI Professional…
Spotfire Analytics – Transforming Clinical Development Despite the billions of dollars spent annually discovering and developing new drugs, the global output of innovative…
1. Practical Biostatistics for Clinical Trials, or How to Find and Use Your Biostatistician Scott Brown, Ph.D. NAMSA 2. 2 Overview Biostatistics Process Finding Your…
Slide 1A History of Stats at the FDA Mary A. Foulkes, Ph.D. U.S. Food And Drug Administration Office of Biostatistics and Epidemiology Center for Biologics Evaluation and…
1.Move into the Fast Lane with eTMF2. Questions we’ll answer: What is a TMF? What are eTMFs and their benefits? What is a DIA TMF Reference Model? How do IRBs/Sponsors/CROs/Sites…
1. eTMF Tricia McQuarrie Clinical Operations Manager 2. Who is Arivis? Arivis has been providing regulatory and clinical infrastructure since 2005 Many Firsts •…
Slide 1Introduction to WHO Prequalification of Medicines Programme Essential requirements Dr Milan Smid and many team colleagues WHO Prequalification of Medicines Programme…
Slide 1 eCTD – A TOOL to QUICK /RELIABLE REGULATORY SUBMISSION Abhay Muthal M.Pharm, Ph.D Sun Pharm Inds Ltd. Vadodara, India Slide 2 Types of Submission Paper Submission…
Slide 1 General Overview to the CTD and Module 1 Gudrun Dora Gisladottir Director Regulatory Affairs Slide 2 Using CTD format Actavis group hf International generic pharmaceutical…