October 10-11, 2011 | Frankfurt, Germany

Throughout Europe, Medical Device corporations are conducting clinical research studies to support the regulatory clearance and market access of new and innovative products, and are facing tremendous challenges in doing so, with evolving regulatory requirements, increased evidence requests from payers, as well as continued site and study management hurdles. In the 4th Annual Q1 Medical Device Clinical Research conference, presenters will address a wide variety of the challenges that organizations are facing, providing clarity and direction for organizations that are both in the process of conducting studies, and that are also considering a clinical study for their product.

A first and perhaps most pressing challenge faced by the industry are evolving regulatory requirements for medical device studies. From continued confusion regarding the implementation of the Medical Device Directive recast, along with updated ISO regulations, companies are facing great difficulty managing regulatory aspects of device studies and approvals. Working with both notified bodies as well as competent authorities to understand requirements, and make adjustments when necessary is a key issue that will be addressed throughout this conference program. Bringing together perspectives from the regulators, ethical committees and industry will provide a well rounded discussion on the challenges and opportunities.

Other topics that will be addressed during this encompassing program will include the growing importance of post marketing research, both for safety and health economic purposes, as well as the use of patient registries in meeting regulatory surveillance requirements. Throughout the program, presenters will represent both small and large medical device corporations, bringing a balanced perspective to the various topics. As with all Q1 programs, the focus will not only include presentations, and case studies, but will also provide ample time for casual networking with attendees, speakers, and sponsor companies.

TOPICS TO BE COVERED

• Designing Clinical Trials for Multi-Benefit Purposes
  
• Identification & Selection Criteria for Medical Device Sites
  
• Working with Ethics Committees - Perspectives and Best Practices
  
• Patient Recruitment Strategies, Targeting the Appropriate Study Subjects
  
• Methods and Opportunities in Motivating Sites in Medical Device Research
  
• Global Medical Device Studies: How Centralization of Data can Efficiently Support Market Access
  
• Successfully Communicating and Maintaining Compliance with Notified Bodies
  
• Pharma Perspective on Clinical Research: the Road Ahead?
  
• Working with Competent Authorities: Focus on Germany and France
  
• Medical Device Regulatory Harmonization Efforts
  
• Successfully Maintaining Compliance during Multi-National Clinical Trials
  
• Successful Utilization of Patient Reported Outcome Measurements
  
• Post-Market Surveillance vs Post-Market Clinical Follow-Up: Understanding the Differences
  
• Challenges & Benefits in Medical Device Patient Registries
• Insurance Considerations for Medical Device Clinical Trials in Europe

| And More |

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KEY PRESENTERS INCLUDE

Isidoros Karatzas, Head, Ethics Sector & General Director of Research & Innovation
European Commission

Ekkerhard Stosslein, Head, Unit for Active Medical Devices & Medical Technology
BfArM

Gert Bos, Head of Clinical and Regulatory Affairs
BSI Group

Claus Bolte, VP Global Medical & Clinical Affairs
Covidien

Philippe Auclair, Chair of the EUCOMED Clinical Investigations Task Force, Sr. Director Regulatory Strategy & Advocacy
Abbott Vascular International

| And More |