Meeting Details

  • Events
    • Event Details
RAPS Roadshow: Medical Device Meeting – a RAPS Roadshow in the UK
Abbott House
Abbott House Vanwall Business Park MaidenheadSL6 4XE United Kingdom
November 28, 2017
4:00 PM - 7:30 PM WET
  • List Price: $25.00
Tuesday, 28 November 2017 16:30–20:30 GMT

Please join RAPS at our Medical Device Meeting—a RAPS Roadshow in the UK. We’ll provide an MHRA update and the integration of ISO 13485 to address the new MDR requirements. Paul Brooks, executive director of RAPS will be the meeting’s keynote speaker.

View More

» View the Table of Contents

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