9th Annual Biomarkers Congress
World Drug Safety Congress Europe 2011
Grange Tower Bridge Hotel
42 Prescot Street, London E1 8GP T: 020 7630 2000
42 Prescot Street, London E1 8GP
How to make and fulfil the right safety procedures
• How to strengthen risk management
• How to improve risk communication effectiveness
• How to improve patient trust
• How to ease regulatory pressure for the full product lifecycle

Drug Safety 
• Risk Management & Surveillance 
• Clinical Safety 
• Epidemiology
• Post Authorisation Safety 
• Qualified Person
• Data Management
• Research & Development
• Patient Safety 
• Technology providers

Schedule of Presentations:

Tuesday, September 13, 2011
08:55:00 Pre Conference Workshop
09:00:00 Registration and refreshments
09:30:00 Inspection Announced
10:50:00 Morning refreshments
11:10:00 Preparation for the Inspection
11:50:00 The Regulatory Perspective
12:30:00 Lunch
13:30:00 During the Inspection
14:30:00 Afternoon refreshments
15:00:00 Post-Inspection – Report, Response, CAPA, Re-Inspection
Wednesday, September 14, 2011
08:00:00 Registration & refreshments | Day One AM
08:40:00 Opening remarks from the chair
09:00:00 KEYNOTE: Drug safety challenges & opportunities facing the pharmaceutical industry Philippe Van der Auwera
09:30:00 Maintaining pace with evolving industry safety strategies to meet regulatory and external developments
10:00:00 Speed networking followed by morning refreshments
10:45:00 US drug safety: regulatory and industry update Khaled Bannout
11:10:00 Globalisation of pharmacovigilance: view from Asia-Pacific
11:35:00 PANEL SESSION: Global safety harmonisation initiatives Khaled Bannout, Noha Kassem,,
12:00:00 Lunch
12:55:00 Day One, Stream 1: RISK MANAGEMENT
12:55:00 Day One, Stream 2: SAFETY DATA MANAGEMENT
13:00:00 Opening remarks from the chair
13:00:00 Opening remarks from the chair
13:05:00 Driving Patient Safety- Phase 3 Onwards, the EHR is Key John Parkinson
13:10:00 Benefit-risk balance: how to maximize the benefit & minimize risk during R&D Michael Forstner
13:30:00 Intelligent management and analysis of safety data in order to improve operational efficiencies and enhance scientific understanding
13:35:00 Organising project teams and governance around benefit-risk management
14:00:00 Risk Management Plans - not just a safety document
14:00:00 Electronic SAE reporting in electronic data capture studies: a case for convergence of technologies
14:25:00 DSURs: the time is now
14:25:00 Creating effective visual tools for the assessment and characterization of pharmaceutical product safety
14:50:00 Get your head in the clouds: how to leverage SaaS-based solutions to streamline Safety Document Distribution
14:55:00 Risk management challenges for small/mid-sized pharma
15:20:00 Afternoon refreshments | Day One PM
15:45:00 Opening remarks from the chair Jon Morris
15:50:00 ROUNDTABLE: Challenges of effective stakeholder benefit/risk communication David Hans-Ulrich Haerry, Ameet Bakhai, Philippe Van der Auwera
16:30:00 Comprehensive, effective and efficient management of the safety signal lifecycle Veronique Basch, Jon Morris
17:00:00 Reporting of safety information to regulatory authorities, ethics committees and study Helmut Brasch
17:30:00 Is your endpoint management effective in today's environment? Lisa Hornick
18:00:00 Evening networking drinks reception
Thursday, September 15, 2011
08:00:00 Refreshments
08:05:00 Breakfast Seminar: From Sourcing to Partnering
09:00:00 Opening remarks from the chair Nayan T. Nanavati
09:10:00 The role pharmacovigilance plays in European studies
09:40:00 KEYNOTE: European legislation update on strengthening the EU pharmacovigilance system - what can we expect?
10:10:00 Regulatory perspective on EU legislation update Mick Foy
10:40:00 PANEL SESSION: New pharmacovigilance legislation: Q&A session Mick Foy, Margaret Ann Walters
11:00:00 Morning refreshments
11:30:00 “Risk/Alert Crisis Management”: How to optimise available information and data sources.
12:00:00 Epidemiology in drug development: positioning to maximize safety throughout the life cycle
12:30:00 Drug safety considerations for vaccine products Dominique Delattre,
13:00:00 Lunch
14:00:00 Use of imaging, safety biomarkers and eIND approaches in preclinical risk assessment Sean Troth
14:30:00 How to develop a drug safety unit in an emerging country – an operational viewpoint
15:00:00 Biosimilars and pharmacovigilance issues Livia Stankovics
15:30:00 How to cope with the complexities of drug safety in biological products
16:00:00 Closing summary: preparing for the safety environment of tomorrow Eleanor S. Segal
16:30:00 Closing remarks from the chair
Friday, September 16, 2011
08:25:00 Post Conference Workshop | Good Pharmacovigilance Practice: returning to the basics to build a solid foundation
08:30:00 Registration and refreshments
09:00:00 Introduction and overview of the day’s key aims
09:15:00 Understanding the foundations and history of pharmacovigilance
10:00:00 Understand the principles of causality analysis and the value of case reports in pharmacovigilance
10:30:00 Morning refreshments
11:30:00 The current international regulatory requirements and the impact on the framework for future PV regulations
12:30:00 Lunch
13:30:00 Concept of proactive signal detection and management and Benefit/Risk Assessments in context of developmental and marketed products
14:30:00 Afternoon refreshments
15:00:00 The important role of pharmacoepidemiology in pharmacovigilance
16:00:00 Group discussion, Q&A and closing remarks
4th Annual Pharma R&D Asia Congress
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