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Documents Fundamentals of EU Regulatory Affairs%2C Fifth Edition Comparative Matrix

Fundamentals of EU Regulatory Affairs Fifth Edition Fundamentals of EU Regulatory Affairs Fifth Edition Copyright © 2011 by the Regulatory Affairs Professionals Society.…

Documents Guidelines for Standard Operating Procedures

PSI Statisticians in the Pharmaceutical Industry GUIDELINES FOR STANDARD OPERATING PROCEDURES for Good Statistical Practice in Clinical Research Written by: PSI Professional…

Documents Spotfire Clinical

Spotfire Analytics – Transforming Clinical Development Despite the billions of dollars spent annually discovering and developing new drugs, the global output of innovative…

Health & Medicine Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician

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…

Documents A History of Stats at the FDA Mary A. Foulkes, Ph.D. U.S. Food And Drug Administration Office of...

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…

Technology Etmf in the fast lane

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…

Health & Medicine Clireo eTMF Solution by arivis

1. eTMF Tricia McQuarrie Clinical Operations Manager 2. Who is Arivis?  Arivis has been providing regulatory and clinical infrastructure since 2005  Many Firsts •…

Documents Introduction to WHO Prequalification of Medicines Programme Essential requirements Dr Milan Smid and...

Slide 1Introduction to WHO Prequalification of Medicines Programme Essential requirements Dr Milan Smid and many team colleagues WHO Prequalification of Medicines Programme…

Documents ECTD – A TOOL to QUICK /RELIABLE REGULATORY SUBMISSION Abhay Muthal M.Pharm, Ph.D Sun Pharm Inds.....

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…

Documents General Overview to the CTD and Module 1 Gudrun Dora Gisladottir Director Regulatory Affairs.

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…