| 8:00 am - 8:30 am |
Continental Breakfast & Registration |
| 8:30 am - 8:45 am |
Welcome and Introduction |
| 8:45 am - 10:00 am |
Session 1 — The Development of Regulatory Rigor
- Public Experience Shapes Public Policy
- The Authority of the FDA
- US Code of Federal Regulations and Guidelines
- Financial Disclosure
- Electronic Records; Electronic Signatures
- HIPAA
|
| 10:00 am - 10:30 am |
Morning Break |
| 10:30 am - 12:00 pm |
Session 2 — Global Perspectives
- The History of the International Conference on Harmonisation (ICH)
- ICH GCP: Consolidated Guideline (E6)
- International Trials
- Clinical Research in Canada
- EU Clinical Trial Directive
|
| 12:00 pm - 1:00 pm |
Lunch |
| 1:00 pm - 2:30 pm |
Session 3 — Managing the Informed Consent Process
- Essentials of Informed Consent
- Developing the Consent Form
- Additional Safeguards for Children
- Methods for Administering Informed Consent: Ensuring Comprehension
- Differences Between DHHS and FDA Informed Consent Regulations
- Informed Consent Exercise
|
| 2:30 pm - 3:00 pm |
Afternoon Break |
| 3:00 pm - 4:30 pm |
Session 4 — Clinical Laboratory Activities
- Laboratory Basics
- Specimen Handling and Shipping Requirements
- Laboratory Credentialing
- Why Sponsors Utilize Central Labs
- Abnormal Labs and AE Reporting
|
| 4:30 pm - 5:00 pm |
Questions and Answers, Adjourn |