*All times are in Eastern Time Zone
12:00 - 12:10 Introduction / Agenda / Certification Program
12:10 - 1:05 Basic Concepts of Compliance
1:05 - 1:15 Questions
1:15 – 2:05 Drug Development
2:05 – 2:20 Break
2:20 – 2:30 Phases of Development
2:30 - 3:15 Device Development
3:15 - 3:45 Prominent Regulations/Ethics
3:45 - 4:00 Questions
12:00 - 1:00 GCP Roles & Responsibilities
1:00 - 1:50 Informed Consent/Common Rule
1:50 - 2:05 Break
2:05 - 2:20 IRBs
2:20 - 2:50 Planning and Coordinating Clinical Trials
2:50 - 3:00 Questions
3:00 - 3:20 Safety Reporting, Study Closure and Record Retention
3:20 - 3:50 Audits/Inspections
3:50 - 4:00 Resources and Final Questions