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12 13 14 15 16 17 18
19 20 21 * REVISION OF THE MEDICAL DEVICE DIRECTIVES
* PHARMACOVIGILANCE FOR SUPPORT STAFF
 22 * BORDERLINES BETWEEN MEDICINES AND FOOD
 23 * REGULATORY AFFAIRS IN THE MIDDLE EAST
* US PATENT PRACTICE
* PRACTICAL INTRODUCTION TO INTERNATIONAL PATENT LAW AND PRACTICE
 24 25
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
  
MEDICAL DEVICES
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FDA ADVERSE EVENT
REPORTING FOR
MEDICAL DEVICES

Understand how to comply with the FDA Requirements
and Regulations

Conference Date: 28-29 Nov 2012
Conference Ref: N11-8112
Fee: £1250 + VAT
Venue: The Rembrandt Hotel, London

Special  discounted rate available if booked together with 'FDA Approval Process for Medical Devices'  pm 26 & 27 November (£2,100 + VAT)

LEARNING OBJECTIVES

  • Discuss the need, purpose and capabilities of Medical Device Vigilance and Post Market Surveillance
  • Define the terms related to reporting adverse events
  • Know how to comply with the requirements and when to report adverse events during clinical trials
  • Learn the process to report adverse events post-approval of a marketed product
  • Discuss and interpret trend analysis of adverse events

If you have any queries please click here to email Andrea James

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