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Pre- & Post- Market Adverse Event Reporting Requirements for European Device Trials
Pre- & Post- Market Adverse Event Reporting Requirements for European Device Trials

Our Price: $395.00

Product Code: WB-7003

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About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.

A primary goal in medical device clinical studies is maximizing a patient’s safety while determining the products efficacy and effectiveness. In order to ensure the greatest degree of safety, adverse event reporting is required in both pre- and post- market phases of development. The former GHTF released guidance regarding pre-clinical trials adverse event reporting (SG5:N5:2012) citing the unique pre-clinical safety problems, but also the newly proposed MDD includes requirements for pre- and post-market adverse event reporting. These newly recommended standards come as additional challenges for clinicians who are also preparing for the clinical provisions outlined in the medical device drafted regulation.
  • Updates on current standards and proposed MDD revision
    • Defining adverse event (AE) and serious adverse events (SAE)
    • Guidance and timelines for pre- and post-market AE and SAE reporting
  • Clarification on common misinterpretations of guidelines
  • Challenges and strategies for implementing pre- and post- market regulations

Annet Muetstege
Director and Co-Founder
Applied Clinical Services BV

Target Audience

  • Clinical Operations/Development
  • Clinical Research
  • Clinical and Regulatory
  • Clinical Safety and Reporting

Target Industry
  • Medical Device Manufacturers

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