Webcast: RAC (US) Exam Preparation Series (2016) – Pharmaceuticals I & II

Starts:  Aug 10, 2016 12:00 (ET)
Ends:  Aug 17, 2016 13:30 (ET)

Webcast Titles/Dates:

10 Aug: Pharmaceuticals I
12:00-1:30pm ET
17 Aug: Pharmaceuticals II
12:00-1:30pm ET

Passing the RAC exam takes hard work and a lot of preparation. As part of a complete study plan for the RAC (US) exam, this popular webcast series can help, particularly with the exam’s analysis and application to the workplace components. This RAPS webcast series will provide applications and examples to help you expand your practical knowledge and put strong foundational knowledge to use. 

The live webcasts include interactive Q&A sessions with subject matter experts covering select topics. This also is a great opportunity to ask questions and clear up any areas of uncertainty you have about the exam.

Plus, you get free access to the recordings for an entire year, so you can revisit the information and make sure you get the most out of it—as many times as you need to.

Learning Levels: Basic, Intermediate

Who Should Attend?

  • Those who have registered or plan to register for the RAC (US) Exam
  • Regulatory professionals of all levels wishing to expand their knowledge

10 August

17 August

  • Introductions and General Principles
  • Overview of the Drug Development Continuum
  • FDA Meetings
  • Investigational New Drug (IND) Requirements and Submissions
  • Special Protocol Assessments
  • IND Maintenance
  • New Drug Application (NDA) Requirements and Submissions
  • Prescription Drug User Fee Act (PDUFA) Fees and Approvals
  • 505(b)(2) NDAs
  • NDA/ANDA Maintenance and Postapproval Activities                   
  • Overview of Over-the-Counter Drug Products
  • Abbreviated New Drug Application (ANDA) Requirements and Submissions
  • Suitability Petitions
  • Generic Drug User Fee Amendments (GDUFA) Fees and Approvals
  • Comparability Protocols
  • Expedited Approval Pathways
  • Orphan Drug Designation
  • Pediatric Research Equity Act (PREA) Requirements
  • Good Manufacturing Practices (GMPs)