9:00am – 9:30am - Introductions & Review of Agenda

9:30am – 10:30am - The Drug Development Process

• Overview of Development
• Phases of clinical development
• Exercise

10:30am – 10:45am - Break

10:45am – 12:00pm - Good Clinical Practice (GCP)

• Principals of GCP
• Role of IRB/IEC, sponsor, investigator
• Exercise 

12:30pm – 1:00pm - Lunch

1:00pm – 2:00pm - Regulations

• History of Regulations
• 21 CFR
• ICH Guidelines
• Role of Regulatory Agencies
• Exercise  

2:00pm – 3:00pm – IND/IMPD

• Definition
• Composition
• Types of INDs & IMPDs
• Review & amendment process
• Exercise

3:00pm – 3:15pm - Break

3:15pm – 4:30pm - IRB/IECs

• Description, composition & role
• Study review and approval process
• Exercise

4:30pm - 5:00pm - Recap, Questions and Answers

                                                          DAY TWO

9:00am – 10:30am - Informed Consent

• Elements
• Process
• Common errors
• Review, approval, amendments
• Exercise

10:30am – 10:45am - Break

10:45am – 11:30am - Monitoring

• Definition
• Types of monitoring visits & tasks
• Role of the CRA 
• Exercise

11:30am – 12:30pm - Adverse Events

• Definitions
• Documenting
• Reporting
• Exercise

12:30pm – 1:30pm - Lunch

1:30pm – 2:45pm - Drug Accountability

• Definition
• Managing clinical supplies
• Compliance
• Exercise

2:45pm – 3:30pm - Fraud

• Types of fraud
• Detecting fraud
• Examples
• Exercise

3:30pm – 3:45pm - Break

3:45pm – 4:30pm – Fraud (continued)

4:30pm – 5:00pm – Recap

• Questions and answers

DAY THREE

9:00am – 9:30am - Post Drug Approval

• Reporting requirements
• Phase IV

9:30am – 10:30am - Monitoring Simulation

• CRF Review
• SDV
• Review & Discussion of Monitoring Simulation

10:30am – 10:45am - Break

10:45am – 11:45am - Monitoring Simulation (continued)

11:45am – 12:30pm - Review and Discussion of Monitoring Simulation

12:30pm – 1:30pm - Lunch

1:30pm – 2:00pm – Course Review

2:00pm – 2:45pm - Recap

• Questions and Answers
• Course Evaluation

RETURN TO COURSE DESCRIPTION