Agenda

Clinical Research Professional Certification Preparation and GCP Review Course

8:00 to 8:30 Registration and Continental Breakfast
8:30 to 9:15

Introduction
Certification Program, Exam Content, Prep Course Agenda,
Pretest Exercise

9:15 to 10:00

Basic Concepts of Compliance

Code of Federal Regulations, 45 CFR 46, ICH E6 (R2)
10:00 to 10:20 Ethical Concepts that Guide GCP Regulations 
10:20 to 11:20      Prominent GCP Regulations Roles & Responsibilities - Sponsors & Monitors 
11:20 to 12:15 Drug Development, Phases of Development, IND, NDA 
12:15 to 12:45 Lunch (Provided)
12:45 to 1:15 Medical Device Development, IDE, PMN and PMA 
1:15 to 2:00 Informed Consent (21 CRF 50)
2:00 to 2:15 Institutional Review Boards (21 CFR 56)
2:15 to 2:30 Break (with opportunity for discussion)
2:30 to 3:00 Planning and Coordinating Clinical Trials
3:00 to 3:30 Records and Reports
3:30 to 3:45 FDA Inspections Organizational Audits 
3:45 to 4:00  Resources
4:00  Q&A