Presentations

Presentations 2008
Janet Hormbrey Executive Director EU Qualified Person for Risk Management and Pharmacovigilance Merck & Co	Further defining post-authorization safety studies: their role in the EU Risk Management Plan (RMP)
Enrica Alteri Global Drug Safety Medical Safety Group Neurology Merck Serono	Safety Issues of biologicals
Saad Shakir Director Drug Safety Research Unit	The role of academia in risk management
Gro Laier Deputy Qualified Person International Product Safety Novo Nordisk	Pharmacovigilance aspects of licensee agreements
Vicki Edwards Director European Pharmacovigilance Abbott	Monitoring and inspecting on pharmacovigilance compliance
Corinne de Vries Professor of Pharmacoepidemiology Department of Pharmacy and Pharmacology University of Bath	Integrating epidemiology and risk management - a streamlined approach to pharmacovigilance
Tjeerd van Staa Head of Research General Practice Research Database (MHRA)	Risk management: counting events or something more?
Dieter Konrad Manager Department of Information Processing Boehringer Ingelheim	EMEA guidelines on the use of statistical signal detection methods in the EudraVigilance Data Analysis System
Ennis Lee Vice President QPPV Pharma Benefit Risk Management Janssen Cilag	RMPs: implementation and follow up
Johan Hopstadius Research Engineer Research & Development The Uppsala Monitoring Centre	Adverse drug reactions surveillance - the experience of Uppsala Monitoring Centre
William Gregory Director Safety and Risk Management Pfizer	Interdependence of data mining and RMPs on Electronic Data Standards in pharmacovigilance
Daniel Reshef Director PDS Risk Management Roche	Signal detection in modern drug safety
Bledar Haderi Drug Safety and Epidemiology Manager AstraZeneca	Intelligent internal and external risk communication
Presentations 2007
WEDNESDAY 23rd May 2007
Graham Bunn Member CDISC	CDISC: examining the latest practical experiences and end-to-end data standardisation
Trudy Kuipers-de Groot Manager EDC & Biometrics Support ASTELLAS Robert Snijder Manager Clinical Programming ASTELLAS	International standardisation through the implementation of a global EDC system
Johann Pröve Global Head Data Acquisition and Management BAYER VITAL	Better control of the e-Clinical Trials process: improving the inter-departmental network
Henning Lux Managing Director QUATRATEK DATA SOLUTIONS	End-to-end electronic data flow from protocol to submission
Jane Clarke Clinical Development Operations Support WYETH	Industry case study: implementing an EDC system while working on advancing your overall efficiency
Graham Bunn VP, Global CRO Partnerships MEDIDATA	Is EDC the next CDMS?
Dr. Fraser Inglis Managing Director GLASGOW MEMORY CLINIC	The perfect EDC system: an investigator’s view
Nasreen Alam Senior Data / EDC Manager MERCK SERONO François Simon Regional Liaison Manager, Emerging Countries/EDC Specialist MERCK SERONO	Integrating sponsor and investigator technologies for best results
Thursday 24th May 2007
David Smith Head of Validation Services ROCHE	Best practices and processes for effectively archiving e-Clinical data
Robert Vollkommer Vice President, Clinical Services C3i Jonathan Palmer European Clinical Solutions Director ORACLE	Acknowledging e-Source as a business solution: has the industry progressed?
Diego Herrera Clinical IT Director ALMIRALL	How to efficiently manage global Clinical Trials by means of one e-Collaboration platform
Fiona Glenny EDC Coordinator LUNDBECK	Challenges in EDC provisioning – keeping up with global Clinical Trials
Norbert Fritz Vice-Director, Business Technical Expert F. HOFFMAN – LA ROCHE	Integrated electronic data flow from data collection to medical review
Jens Reinhold Director EDC/ e-PRO Implementation Management BAYER SCHERING	Global e-Diary applications – a sure-fire success?
Stéphane Marzabal Manager Data Management MERCK SERONO	Use of metrics in the clinical organisation: measuring impact of new processes
David Connelly CEO CMED	Adaptive design: managing EDC as the Clinical Trial progresses
Christian Grøndahl Project Vice President, e-Clinical Global Developmen NOVO NORDISK	Best practices in integrating a range of systems for a successful e-Clinical programme
Presentations 2006
Michael Brücks Vice President Accounting Principles and Policies DEUTSCHE TELEKOM	International Financial Reporting Standards vs. national and US accounting standards: how to handle the differences?
Alecos Papadopoulos MSc CIA Finance & Administration Dpt Manager HELLAS ON LINE	Harnessing revenue recognition in financial statements
Edgar Borg Group Finance Director MALTACOM	Reviewing IAS 18 through both generic and case-study perspectives
Jens Faarup Financial Director SONOFON	Discussing the challenges surrounding impairment testing
Dale Clark Partner KPMG	Tracing the changes in the accounting rules and their impact on future Telco strategy: a status report on IASB´s and FASB´s joint project on "performance reporting"
Steven Brice Head of IAS Technical Partner MAZARS	Charting the course ahead: reflecting the latest IASB thoughts and likely implications for the Telecoms sector for 2006/7