Nov. 13-15, 2012 Course - Videos and Slides

 Tuesday, November 13, 2012

Agenda (PDF - 95KB) Video: Morning Session https://collaboration.fda.gov/p90041173/ Slides: Morning Session 8:30 - 9:00 a.m. FDA Structure and Mandate (PDF - 1MB) 9:00 - 10:00 a.m. The Design of Clinical Trials (Part I) (PDF - 1MB) 10:15 - 10:45 a.m. The Design of Clinical Trials (Part II) (PDF - 1MB) 11:00 - 11:30 a.m. Clinical Trial Endpoints (PDF - 76KB) 11:30 - 12:00 p.m. Issues in Clinical Trial Designs for Devices

https://collaboration.fda.gov/p95571726/

Slides: Afternoon Session

1:00-1:30 p.m.    Issues in Clinical Trial Designs for Diagnostics and Combination Products
1:30-2:15 p.m.    Informed Consent and Ethical Considerations in Clinical Trials (PDF - 568KB)
2:45-3:15 p.m.    Safety Considerations in Phase 1 Trials (PDF - 130KB)
3:15-3:45 p.m.    Safety Assessment in Clinical Trials and Beyond (PDF - 125KB)
3:45-4:15 p.m.    Clinical Discussion of Special Populations (PDF - 505KB) 

Wednesday, November 14, 2012

Video: Morning Session  https://collaboration.fda.gov/p76535953/   Slides: Morning Session 8:30 - 9:00 a.m. FDA Perspective on International Studies 9:00 - 9:45 a.m. Good Clinical Practice (PDF - 83KB) 9:45-11:00 a.m. Investigator Responsibilities - Regulation and Clinical Trials (PDF - 1.5MB) 11:00-11:45 p.m. The Analysis of Investigator Data, Sources of Bias and Error (PDF - 258KB)

https://collaboration.fda.gov/p46012901/

Slides: Afternoon Session

1:00-1:30 p.m.    CMC and the Investigator Brochure (Drugs): Ensuring the Quality of a Drug Used in a Clinical Trial (PDF - 227KB)
1:30-2:00 p.m.    CMC Issues in Gene Therapy (PDF - 627KB)
2:00-2:45 p.m.    Pharmacology/Toxicology in the Investigator Brochure (PDF - 131KB)
3:15-4:00 p.m.    Clinical Pharmacology 1: Phase 1 Studies and Early Drug Development (PDF - 371KB)
4:00-4:45 p.m.    Clinical Pharmacology 2: Clinical Considerations During Phase 2 and Phase 3 of Drug Development (PDF - 438KB) 

Thursday, November 15, 2012

Video:  Morning Session  https://collaboration.fda.gov/p69921957/ Slides: Morning Session 8:30-10:00 a.m. How to Put Together an Application (CDER) (PDF - 262KB) How to Put Together an Application (CBER) (PDF - 263KB) How to Put Together an Application (CDRH) (PDF - KB)

Slides: Morning Session (continued)

10:15-11:15 a.m.    Ensuring the Safety of Clinical Trials: 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.    Device Post Approval and Registry Studies (CDRH)
 

Video: Afternoon Session

https://collaboration.fda.gov/p97969494/ 

Slides: Afternoon Session

12:45-1:15 p.m.   Special Cardiac Safety Issues: QT Prolongation and Valvulopathy (PDF - 300KB)
1:15-1:45 p.m.     Drug-Induced Liver Injury (DILI) (PDF - 377KB)
1:45-2:15 p.m.     A Patient Advocate's Perspective on Clinical Trials (PDF - 100KB)
2:15-3:15 p.m.     Roundtable: A Pharmaceutical Industry Perspective on the Clinical Investigator's Role in Drug Development - 1)The Investigator as the Custodian of the Data Chain (PDF - 93KB) 2)The Investigator As Trusted Partner (PDF - 165KB)