Agenda

8:00 to 8:30

Registration and Continental Breakfast

8:30 to 9:00

Introduction & Pre-Test

9:00 to 9:25

Study Start-Up: Ethical Foundations 

9:25 to 9:50

Study Start-Up: Overview of Research Regulations

9:50 to 10:05     

10:05 to 11:05

Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access

11:05 to 12:05

Study Start-Up: Device Development

12:05 to 12:50

Lunch (Provided)

12:50 to 1:50

Conduct of Study: Clinical Protocols, Sponsor, Investigator & Monitor Responsibilities & Financial Disclosure

1:50 to 2:05

Conduct of Study: Institutional Review Board (IRBs) 

2:05 to 2:20

Break (with opportunity for discussion)

2:20 to 3:20

Conduct of Study: Informed Consent

3:20 to 3:40

Conduct of Study: Managing Study Compliance and Safety Reporting

3:40 to 3:45

Study Close-Out: Study Closure/Record Retention and Regulatory Submission/Postmarket 

3:45 to 4:00 

Conduct of Study: Inspections and Audits

4:00 

Q&A