Meeting Details

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EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations
Only 5 Seats Remaining
Location:
Sofitel EU Brussels
Place Jourdan 1 1040Bruxelles Belgium
Date:
July 4-5, 2017
Credits:
8.00 RAC

This one-and-a-half-day workshop is based on the highly-regarded and consistently sold out EU workshop at RAPS Regulatory Convergence. Offered for the first time in Europe, the workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

  • List Price: $1,050.00
  • Member Price: $950.00
 
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This one-and-a-half-day workshop is based on the highly-regarded and consistently sold out EU workshop at RAPS Regulatory Convergence. Offered for the first time in Europe, the workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs...

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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