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Medical Device Development: U.S. and EU Differences August 2012

Aug 30, 2012
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Course Description 

While some medical devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate – with safety and effectiveness data in the target population – that the product is safe for human use. The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make the approval process in each country straightforward – but is it? This web seminar works through the requirements for medical devices and the steps to obtain entry into the marketplace. The way in which medical devices are regulated in the EU and how very different from the way they are regulated in the United States will be discussed.

VideoPreview 

 
Learning Objectives 

  • Describe the various types of medical device clinical trials
  • Review how clinical trial design impacts the marketing of a medical device
  • Examine the regulatory requirements associated with medical device clinical trials
  • Explain why time-to-market approval timelines can differ so extensively
  • Examine the clinical data requirements for market approval in the two systems
  • Compare regulatory differences 

Who Should Attend 

  • Project Managers
  • Clinical Research Associates
  • Quality Assurance Personnel
  • Regulatory Affairs Professionals

Instructor 

Sandy Soliman

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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)