Nov. 7-9, 2011 Course - Videos, Slides, Transcripts

 Monday, November 7, 2011

Video: Morning Session https://collaboration.fda.gov/p52033364/ Slides: Morning Session 8:30 -   9:00 a.m. FDA Structure and Mandate (PDF - 1MB) 9:00 -   9:45 a.m. Good Clinical Practice - Key Topics (PDF - 79KB) 9:45 -  11:00 a.m. Investigator Responsibilities - Parts 1 and 2 (PDF - 1MB) 11:00 - 11:45 a.m. Informed Consent and Ethical Considerations (PDF - 670KB)

Video: Afternoon Session

https://collaboration.fda.gov/p25725932/

Slides: Afternoon Session

1:00-1:30 p.m.  CMC and the Investigator Brochure (Drugs) (PDF - 180KB)
1:30-2:00 p.m.  CMC and the Investigator Brochure (Biologics) (PDF - 63KB)
2:00-2:45 p.m.  Pharmacology/Toxicology in the Investigator Brochure (PDF - 157KB)
3:15-4:00 p.m.  Clinical Pharmacology 1 (PDF - 263KB)
4:00-4:45 p.m.  Clinical Pharmacology 2 (PDF - 473KB)
 

Tuesday, November 8, 2011

Video: Morning Session https://collaboration.fda.gov/p86158174/ Slides: Morning Session 8:30- 9:00 a.m. FDA Perspective on International Studies (PDF - 596KB) 9:00-10:45  a.m. The Design of Clinical Trials (Parts I and II) (PDF - 1MB) 11:00-11:30 a.m. Clinical Trial Endpoints (PDF - 99KB) 11:30-12:00 p.m. Issues in Clinical Trial Designs for Devices (PDF - 287KB)

https://collaboration.fda.gov/p45318823/

Slides: Afternoon Session

1:00-1:30 p.m.  Issues in Clinical Trial Design (PDF - 294KB)
1:30-2:15 p.m.  The Analysis of Investigator Data, Sources of Bias and Error (PDF - 1MB)
2:45-3:15 p.m.  Safety Considerations in Phase 1 Trials (PDF - 99KB)
3:15-3:45 p.m.  Safety Assessment in Clinical Trials and Beyond (PDF - 137KB)
3:45-4:15 p.m.  Clinical Discussion of Special Populations (PDF - 486KB)
 

Wednesday, November 9, 2011

Slides: Morning Session              8:30-10:00   a.m. How to put together an application (Milstein) (CDER) (PDF - 255KB) How to put together an application (Purohit-Sheth) (PDF - 263KB) 8:30-10:00   a.m. How to put together an application (Fink) (CBER) (PDF - 204KB) How to put together an application (Au) (CBER) (PDF - 204KB) How to put together an application (Witten) (CBER) (PDF - 433KB) 8:30-10:00   a.m. How to put together an application (Marcarelli) (CDRH)  How to put together an application (Henley) (CDRH) (PDF - 858KB)

10:15-11:15 a.m.     Ensuring the Safety of Clinical Trials (PDF - 111KB): AE Reporting, DSMBs, IRBs (CDER)
10:15-11:15 a.m.     Ensuring the Safety of Clinical Trials: AE Reporting, DSMBs, IRBs (CBER)
10:15-11:15 a.m.     Ensuring the Safety of Clinical Trials: AE Reporting, DSMBs, IRBs (CDRH)

Video: Afternoon Session

https://collaboration.fda.gov/p97371694/

Slides: Afternoon Session

12:45-1:15  p.m.       Special cardiac safety issues: QT prolongation and valvulopathy (PDF - 297KB)
 1:15-1:45  p.m.        Drug-Induced Liver Injury (DILI) (PDF - 399KB)
 1:45-2:15  p.m.        A patient advocate's perspective on clinical trials (PDF - 108KB)
 2:15-3:15  p.m.        Roundtable (PDF - 234KB)