Agenda

Clinical Research Professional Certification Preparation and GCP Review Course


Day 1


8:00 to 8:30

Registration and Continental Breakfast

8:30 to 9:15

Introduction

9:15 to 10:00

Basic Concepts of Compliance

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