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Medical Devices Directives: Lessons Learned and the Way Forward

 
  July 19, 2010  
     
 
Regulatory Affairs Professionals Society (RAPS), Brussels
18-19 November 2010


Schedule at a Glance
18–19 November 2010
Brussels

Thursday, 18 November 2010

10:00­–10:15

Welcome and Introduction
10:15–11:00Overview of EU Legislation:
Regulatory Priorities in a Changing Environment
11:00–12:30Market Surveillance: Practical Experience & Case Studies
12:30–13:30Luncheon Provided
13:30–15:00Clinical Studies:
Lessons Learned and Suggestions for Harmonisation
15:00–15:30Coffee Break Provided
15:30–17:00Defining Postmarket Surveillance:
Beyond Vigilance and Postmarket Clinical Follow-up (PMCF) Obligations
17:00–17:30Q&A With Audience:
Conclusion of the First Day

 
Friday, 19 November 2010
9:00–9:15Welcome and Introduction to the Second Day
9:15–10:30International Environment: Time to Market
10:30–10:45Coffee Break Provided
10:45–11:45Future of Innovation
11:45–12:45Looking Forward: Next Changes
12:45–13:15Concluding Remarks
 
 
Organized by: Regulatory Affairs Professionals Society (RAPS)
Invited Speakers:

Philippe Auclair, PhD, senior director, regulatory strategy and advocacy, Abbott quality and regulatory EMEA, Abbott Vascular International.

 Rainer Voelksen, executive, international regulatory affairs, GE Healthcare EMEA.

 
Deadline for Abstracts: N/A
 
Registration:
REGISTRATION FEESRegister by 28 October 2010Register after 28 October 2010
RAPS Member$1495 (approx. €1,095)$1595 (approx. €1,165)
Nonmember*$1685 (approx. €1,235)$1785 (approx. €1,165)
Multiple Members**$1295 each (approx. €945)$1395 each (approx. €1,020)
Multiple Nonmembers*$1585 each (approx. €1,155)$1685 each (approx. €1,235)

Fees are charged in US dollars. Euro values are approximate.

* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.
** Multiple registration fees require three or more participants from the same company to submit individual registration forms at the same time via fax, mail or email to the RAPS Solutions Center.

Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 11 November 2010 unless meeting capacity is reached; after 11 November 2010, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 28 October 2010
E-mail: acallery@raps.org
 
   
 
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