Preparing for the RAC Exam - Module 1 Strategic Planning, Design and Development

RAC exam
– Content and format
– Proven methods for efficient study
– Test taking strategies
• Practice questions
– Review best answer
– Discuss rationale / supporting content
• Opportunity to ask questions
• Additional references and definitions for you to study
later
Audience Poll Question
We’d like to know who is in our audience today.
Please indicate whether you primarily work in
Drugs, Biologics or Devices.
A Drugs
B Biologics
C Devices
RAC Exam Content
• US laws, regulations, policies and guidelines
– Pharmaceuticals
– Biologics
– Medical Devices
– Biotechnology
• GCPs, GMPs, GLPs
• Key submissions (IND, NDA/BLA, IDE, PMA, etc.)
• Chemistry, Manufacturing and Controls
• Agency interactions
• Post approval requirements