Presentations Available Online:

FDA PUBLIC HEARING

Sentinel Network to Promote Medical Product Safety
Link to Online PDF File of Presentation

What are the current gaps in postmarket medical product safety data collection and risk identification and analysis?

How can postmarket medical product safety data collection be integrated into workflow of clinical practice at point-of-care while avoiding  imposition of undue burdens on HCPs, patients, and health care institutions?

How readily can existing systems be used or be modified to serve as dynamic surveillance loops (e.g., constant integration of data collection from, analysis, and feedback of information to health care practitioners and patients at the point-of-care)?
 

FDA PUBLIC HEARING

CDER’s Current Risk Communication Strategies for Drugs
Link to Download PowerPoint Presentation*

How easily accessible and understandable are FDA's Internet-based sources of drug information?

What are the strengths and weaknesses of the following communication tools: Patient and Healthcare Professional Information Sheets; Talk Papers; Press Releases; Public Health Advisories (PHAs); MedWatch Safety Updates; amd the Patient Safety News program?
 

* Requires Microsoft™ PowerPoint, PowerPoint Viewer or their equivalent to view.
Link to Download Free PowerPoint Viewer

 

FDA RISK MANAGEMENT PUBLIC WORKSHOP

Risk Assessment of Observational Data:
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Link to Online Slide Presentation

 How can the quality of spontaneously reported case reports be improved?