Meeting Details

  • Events
    • Event Details
RAPS Chicago Chapter: Effective Medical Device Presubmission Interactions
100 Abbott Park Rd Abbott Park, IL 60064-3502
January 23, 2017
5:30 PM - 8:30 PM CT
2.00 RAC
  • List Price: $55.00
  • Member Price: $40.00
Want to save more?
to see if you qualify for a lower rate.
Members: save $15.00 or more

23 January 2017
5:30–8:30 pm CST
AbbVie Inc.
North Chicago, IL

Join your regulatory colleagues from the Chicagoland area for an evening of networking and an interactive presentation on the Medical Device Presubmission process. The program is brought to you by the RAPS Chicago Chapter and is intended...

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