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Making Risk-Benefit Decisions – Preparing for the New FDA Guidance Documents

 April 6, 2012


Location


Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA

Description


This webinar on risk-benefit decisions in medical device manufacturing provides attendees with an understanding of the two recently released FDA draft guidance documents - “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices”.

Areas Covered in the Seminar:

- The Risk/Benefit Draft Guidance
- Safety and Effectiveness
- Measurement Factors for Safety and Effectiveness
- Other Factors
- Examples
- Pivotal Clinical Investigations Draft Guidance
- Pivotal Studies
- Clinical Outcome Studies
- Diagnostic Clinical Performance Studies
- Linkages to Risk Management

Organized by


Compliance Online
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America

More Information


Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915

Event's Website



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