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