Biotech China 2014
Pharmacovigilance Summit
Copthorne Tara Hotel
Scarsdale Place
Kensington, London
http://www.smi-online.co.uk/events/overview.asp?is=4&ref=3492
A conference on the latest developments in Risk Management, Product Life Cycle Management, and Post-Marketing Surveillance


The practice of Pharmacovigilance is now more necessary than ever. With the sharp increase in product recalls and litigation cases in recent years, the need for the Pharmaceutical industry to scrutinise each of its new drugs activity and effects has become of paramount importance. 

The potential problems arising from a lack of proper compliance to correct Pharmacovigilance procedures can be catastrophic, ranging from patient sickness and death, to significant damage to a companies financing and reputation.

Schedule of Presentations:

Monday, March 14, 2011
08:30:00 Registration & Coffee
09:00:00 Chairman's Opening Remarks Peter Schiemann,
09:10:00 PRACTICAL ISSUES IN PHARMACOVIGILANCE INSPECTIONS Mechthild Waldeyer
09:50:00 QUALITY RISK MANAGEMENT AS THE QUALITY MANAGEMENT PRINCIPLE Peter Schiemann,
10:30:00 Morning Coffee
11:00:00 MANAGING CLINICAL SAFETY WHEN MANUFACTURING EXPERIENCES SIGNIFICANT GLITCHES Mariska Kooijmans
11:40:00 INSPECTIONS... ARE YOU READY? Karen Pattenden
12:20:00 PREPARING FOR AND SURVIVING PV INSPECTIONS Mary O'Hare
13:00:00 Networking Lunch
14:00:00 PERIODIC SAFETY REPORTING DURING CLINICAL DEVELOPMENT AND THE DSUR E. Stewart Geary
14:40:00 PHARMACOVIGILANCE INSPECTIONS INVOLVING THE MHRA AND FDA Patricia Bocciarelli
15:20:00 Afternoon Tea
15:50:00 PANEL DISCUSSION Mariska Kooijmans, E. Stewart Geary
16:30:00 RECENT CHANGES TO THE PHARMACOVIGILANCE LEGISLATION
17:10:00 Chairman’s Closing Remarks and Close of Day One
Tuesday, March 15, 2011
08:30:00 Re-Registration & Coffee
09:00:00 Chairman's Opening Remarks Mariska Kooijmans
09:10:00 DRUG SAFETY IN EARLY PHASE ONCOLOGY TRIALS - CASE STUDIES Catarina Macedo
09:50:00 OPTIMIZING THE CLINICAL SAFETY CONTRIBUTION TO THE MANAGEMENT OF MANUFACTURING QUALITY ISSUES Barbara Donner
10:30:00 Morning Coffee
11:00:00 RISK MANAGEMENT – WHAT ARE WE LEARNING? Saad Shakir
11:40:00 MANAGING BENEFIT/RISK FOR MATURE MEDICINES: A CASE STUDY Katja Kusche
12:20:00 ADVERSE EVENT(S) REPORTING FROM A NON-CLINICAL SAFETY PERSPECTIVE George C. McCormick
13:00:00 Networking Lunch
14:00:00 PHARMACOVIGILANCE IN PROMOTION: NECESSITY OR ARGUMENT? Michèle Sangeleer
14:40:00 SIGNAL DETECTION IN THE UK Shelley Gandhi
15:20:00 Afternoon Tea
15:50:00 MANAGEMENT OF SAFETY DATA FROM RELATED RESEARCH ACTIVITIES
16:30:00 SIGNAL DETECTION AND ASSESSMENT IN A CLINICAL-PHARMACOLOGICAL PERSPECTIVE Ronald Meyboom
17:10:00 Chairman’s Closing Remarks and Close of Day Two
4th Annual Pharma R&D Asia Congress
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