Safety Signal Detection 2012 Agenda
*Denotes Inclusion of Real-Life Scenarios or Case Histories
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration/Continental Breakfast |
9:00 a.m. – 10:30 a.m. |
FDA Regulatory Requirements for Clinical Safety and Postmarketing Pharmacovigilance
|
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 12:00 p.m. |
Adverse Event Reports: Multiple Sources, Multiple Issues
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 3:00 p.m. |
Adverse Event Reports: Multiple Sources, Multiple Issues CONTINUED
|
3:00 p.m. – 3:15 p.m. |
Break |
3:15 p.m. – 4:00 p.m. |
EU Regulatory Requirements for Clinical Safety and Postmarketing Pharmacovigilance – An Update |
4:00 p.m. – 4:30 p.m. |
Hands-On Exercise in Clinical Pharmacology and Case Assessment |
4:30 p.m. |
Session Wrap-up |
DAY TWO |
|
8:00 a.m. – 9:00 a.m. |
Registration/Continental Breakfast |
9:00 a.m. – 10:30 a.m. |
Labeling: Regulatory Requirements and Relation to Signal Detection and Evaluation
|
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 12:00 p.m. |
Risk Management, Data Mining and Epidemiology
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:00 p.m. |
Inspections for Clinical Safety and Postmarketing Pharmacovigilance
|
2:00 p.m. – 2:30 p.m. |
ICH E2E: Pharmacovigilance Planning |
2:30 p.m. – 3:00 p.m. |
Hands-On Exercise in Labeling Revision |
3:00 p.m. – 3:15 p.m. |
Break |
3:15 p.m. – 4:15 p.m. |
Assessment, Communication and Management of Medical Product Risk: How Effective is Effective Enough? |
4:15 p.m. |
Adjourn Workshop |