Meeting Details

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    • Event Details
RAPS Roadshow: Examining the New European Medical Device and IVD Regulations
SciPro Life Sciences Professoinals
Seidlstrasse 28 Maxvorstadt 80335 Muenchen Germany
May 4, 2017
5:00 PM - 8:00 PM CET
  • List Price: $40.00

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Please join regulatory professionals in your region for the first Regulatory Affairs Professionals Society (RAPS) Roadshow in Europe. This event will feature RAPS’ executive director Paul Brooks, a recognized expert on medical device regulations. His presentation will address the...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design