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Insight into Proposed NEW EU Clinical Trial Regulation & Implications for Pharmaceutical & Medical Device Manufacturers



 
Our Price: $395.00

Product Code: WB-7077
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About the Product
Includes 1 hour and 45 minute Windows Media Video File and PowerPoint presentations for immediate download.


European legislators are currently working toward the implementation of a harmonized clinical trial regulation, which may directly affect pharmaceutical clinical studies, and indirectly affect medical device clinical studies, taking place in EU member states as early as 2016. The clinical trial regulation, which was endorsed by the European Parliament on April 2, 2014, would override the current clinical trial directive (2001/20/EC) with a simplified, synchronized process for the submission and approval of clinical trial dossiers, as well as provide important new guidelines for the public transparency of clinical study findings. While industry is generally supportive of these initiatives, many regulatory and clinical teams are concerned about the implications the regulation will have on established clinical processes and procedures.
  • Discussing expectations when migrating from a directive to a regulation
  • Defining new requirements for clinical results public transparency
  • Implementing proactive measures to fulfill proposed requirements
  • Rational and industry comments on potential regulation
  • Understanding non-compliance consequences and fines
  • Forecasting next steps and implications for industry and patients

Speakers:
Ulf Grundmann
Partner
King & Spalding

Beverly H Lorell, MD
Senior Medical and Policy Advisor
King & Spalding


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this webinar are:

  • Regulatory Affairs
  • Legal Counsel/Affairs
  • Clinical Affairs & Operations

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