|
8:00 to 8:30 |
Registration and Continental Breakfast |
|
8:30 to 9:15 |
Introduction & Pre-Test |
|
9:15 to 10:00 |
Study Start-Up: Ethical Foundations |
|
10:00 to 10:20 |
Ethical Concepts that Guide GCP Regulations |
|
10:20 to 11:20 |
Study Start-Up: Drug Development and Trial Design, Investigational New Drug Application and Expanded Access |
|
11:20 to 12:15 |
Study Start-Up: Device Development |
|
12:15 to 12:45 |
Lunch (Provided) |
|
12:45 to 1:15 |
Conduct of Study: Clinical Protocols and Sponsor Responsibilities |
|
1:15 to 2:00 |
Conduct of Study: Investigators, Monitors and Financial Disclosure |
|
2:00 to 2:15 |
Conduct of Study: Institutional Review Board (IRBs) |
|
2:15 to 2:30 |
Break (with opportunity for discussion) |
|
2:30 to 3:00 |
Conduct of Study: Informed Consent |
|
3:00 to 3:30 |
Conduct of Study: Managing Study Compliance and Safety Reporting |
|
3:30 to 3:45 |
Conduct of Study: Inspections and Audits |
|
3:45 to 4:00 |
Study Close-Out: Study Closure/Record Retention and Regulatory Submission/Postmarket |
|
4:00 |
Q&A |