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19 20 * FDA APPROVAL PROCESS FOR MEDICAL DEVICES
* FROM CORE SAFETY INFORMATION TO LOCAL LABELLING
 21 * REVISION OF THE MEDICAL DEVICE DIRECTIVES
* PHARMACOVIGILANCE FOR SUPPORT STAFF
 22 * BORDERLINES BETWEEN MEDICINES AND FOOD
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* PRACTICAL INTRODUCTION TO INTERNATIONAL PATENT LAW AND PRACTICE
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26 27 28 29 30 * CRO / VENDOR MANAGEMENT IN THE PHARMACEUTICAL INDUSTRY
 31 * THE NEW ROLE OF THE QUALIFIED PERSON UNDER THE MEDICAL DEVICES DIRECTIVES
  
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PHARMACOVIGILANCE

A Basic Training for those working on Drug Safety
Monitoring in the EU, USA and Japan

Conference Date: 10-12 Dec 2012
Conference Ref: A12-1012
Fee: £1675 + VAT
Venue: The Cavendish Hotel, London

KEY TOPICS TO BE ADDRESSED AT THIS CONFERENCE:-

  • Principles of Pharmacovigilance and Data Resources
  • Risk Management and the development of the Pharmacovigilance Plan
  • Causality Assessment: Clinical Diagnosis of Adverse Events
  • Pharmacoepidemiological Studies
  • PSURs and the link with DSURs and the EU risk management plan
  • Proactive Pharmacovigilance Pre- and Post Marketing
  • Pharmacovigilance Regulations (clinical trials & post-marketing)
  • Risk/Benefit Analysis
  • Dug Surveillance in countires outside Europe
  • Post-marketing Surveillance: Observational Cohort Studies
  • Global pharmacovigilance regulations and systems and their link with EU pharmacovigilance
  • Practical Pharmacovigilance Workshop

CHAIRMEN:

Dr. Barry Arnold, Qualified Person for Pharmacovigilance, AstraZeneca R&D, UK 

Dr. Glyn Belcher, Consultant, PV Consultanty Ltd. . 

Professor Saad Shakir, Director Drug Safety Research Unit, UK

SPEAKERS        

Dr. Carol Markwell, Drug Safety Solutions Ltd, UK

Dr John Parkinson, Director, Clinical Practice Research Datalink - MHRA, UK

 Dr John Talbot, Senior Lecturer at University of Hertfordshire

 Dr Lynda Wilton, Research Fellow, Centre Paediatric Pharmacy Research, School of Pharmacy, University of London.

Speaker from MHRA to be confirmed 

 

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