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8:00 to 8:30 |
Registration and Continental Breakfast |
|
8:30 to 9:15 |
Introduction |
|
9:15 to 10:00 |
Basic Concepts of Compliance |
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10:00 to 10:20 |
Ethical Concepts that Guide GCP Regulations |
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10:20 to 11:20 |
Prominent GCP Regulations Roles & Responsibilities - Sponsors & Monitors |
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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 |