*All times are in Eastern Time Zone
12:00 - 12:10 Introduction / Agenda / Certification Program
12:10 - 12:20 Certification Program, Exam Content, Prep Course Agenda
12:20 - 12:40 Pretest Exercise
12:40 - 1:05 Basic Concepts of Compliance, Code of Federal Regulations, 45 CFR 46, ICH E6 (R2)
1:05 - 1:25 Ethical Concepts that Guide GCP Regulations
1:25 - 1:45 Prominent GCP Regulations Roles and Responsibilities - Sponsors & Monitors
1:45 - 2:00 Break
2:00 - 2:30 Prominent GCP Regulations Roles and Responsibilities - Monitors & Investigators
2:30 - 3:30 Drug Development, Phases of Development, IND and NDA
3:30 - 4:00 Questions
12:00 - 12:45 Medical Device Development, IDE, PMN and PMA
12:45 - 1:30 Informed Consent (21 CFR 50)
1:30 - 1:45 Institutional Review Boards (21 CFR 56)
1:45 - 2:00 Break
2:00 - 2:30 Planning and Coordinating Clinical Trials
2:30 - 3:05 Records and Reports, Study Closure, Record Retention
3:05 - 3:35 Audits/Inspections
3:35 - 3:45 Resources
3:45 - 4:00 Final Questions