Biotech China 2014
Informa Life Science’s annual Signal Detection& Risk Management
Park Hotel
Stadhouderskade 25,
Amsterdam, The Netherlands
http://www.informa-ls.com/signal
Informa Life Science’s annual Signal Detection& Risk Management
Informa Life Science’s
http://www.informa-ls.com/signal
Park Hotel
Stadhouderskade 25,
Amsterdam
The Netherlands

Schedule of Presentations:

Tuesday, December 9, 2008
08:30:00 Coffee and Registration
09:00:00 Opening remarks from the Chairperson
09:10:00 Gaining a regulatory insight into signal detection methodologies and compliance Charlotte van Noord,
09:50:00 Using quantitative analysis to draw signals from the clinical database Georg Ferber,
10:30:00 Morning coffee
11:00:00 Pharmacovigilance/risk management approaches to supporting qualitative signal detection Sandip Chaudhuri,
11:40:00 Spotlight session
12:10:00 Maximising signal detection strategies within a small company Michol Rindone,
12:50:00 Lunch
14:10:00 Practical implementation experience from Nycomed’s new signal detection process Ulrich Bothner,
14:40:00 Signal detection in the world's largest ADR database: Challenges and opportunities Kristina Star,
14:50:00 Successful study design and interpretation of Pharmaco-epidemiological studies and registries
15:30:00 Afternoon coffee
16:00:00 Communicating drug safety to the public Bledar Hadëri,
17:20:00 Closing remarks by the Chairperson and end of day 1
Wednesday, December 10, 2008
08:20:00 Annoucements
08:25:00 "Informa Life Science’s annual Signal Detection& Risk Management"
09:00:00 Opening remarks by the Chairperson
09:00:00 Opening remarks by the Chairperson
09:10:00 Gaining a regulatory perspective: How do Regulators analyse a risk management plan? Sabine Straus,
09:50:00 Risk assessment and management of biopharmaceuticals Thijs Giezen,
10:30:00 Morning coffee
11:00:00 Creating a risk management plan for a drug produced by a small company Martin Goldman,
11:40:00 Experience of compiling a successful RMP Jutta Syha,
12:20:00 Lunch
13:40:00 Development of a risk management plan for an orphan drug Erica Velthuis-te Wierik,
14:20:00 Examining the latest developments in risk/benefit assessments William Maier,
15:00:00 Afternoon coffee
15:30:00 Bringing your risk management plans in line with the latest FDA requirements Orit Neudorfer,
16:10:00 Discussion Session
16:30:00 Closing remarks by the Chairperson and end of conference
4th Annual Pharma R&D Asia Congress
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