Day one- STREAM 2: SAFETY DATA MANAGEMENT

• › Stephen Furlong, Safety Science Lead, US Patient Safety,, AstraZeneca

Updates on Sentinel and Mini-sentinel
Implications for overall safety profile and labelling
 

• › Ronald Leong, Executive Director, Patient Safety USA, AstraZeneca Pharmaceuticals

• Brief history of signal detection- how did we get here
• Current regulations and requirements- what is mandatory vs. nice to have
• Systems in use i.e. what are we up against
- Regulatory authorities
- Global health organizations
- Small institutions
• Signal detection in Pharmaceutical and Biotechnology companies
- Methods 
- What is feasible for big vs. small companies
 

• › Sylvia Dobo, Executive Director, product safety and epidemiology, BioCryst Pharmaceuticals

There is an increasing need to understand drug safety signals quickly.
• The amount of electronic health data will continue to grow both in the U.S. and in Europe.
• Regulators expect innovators to use electronic health data to assess drug safety when appropriate.
• Technological challenges in terms of the storage and processing of data are likely.
• Large scale initiatives that involve using large sources of data in assessing drug safety include:
-        Sentinel Initiative
-        OMOP (Observational Medical Outcomes Partnership)
-        ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)

• › Steve Niemcryk, Head Global Surveillance and Pharmacoepidemiology, Abbott