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Regulatory Strategy Forum for Medical Devices

 
  January 25, 2011  
     
 
Regulatory Affairs Professionals Society (RAPS), Memphis, TN, USA
1-2 March 2011


In this highly interactive, hands-on Regulatory Strategy Forum, proven experts from the medical device industry will lead you in engaging discussions and interactive case studies analyses that will give you the insight and tools you need to develop a successful global regulatory strategy.

In addition to gaining an appreciation for global differences in submission formats and filing strategies and an understanding of the critical importance of monitoring and revising your strategy, you will examine such vital subjects as:

  • Regulatory intelligence
  • Business partnerships
  • Essential elements of a Global Regulatory Strategy Document (GRSD) and Design Dossier

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. Successful global regulatory strategies maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. By engaging in in-depth analysis and workgroup collaboration, you will gain a thorough understanding of ways to enhance your strategy and further your product’s success.



Learning Objectives

  • Define the role of regulatory strategy in product development and lifecycle management including who should be involved in setting the strategy as well as mechanisms for researching requirements and ensuring your documentation is up-to-date
  • Outline the major components of a Global Regulatory Strategy Document (GRSD) and the content for each section
  • Identify specific regulatory issues related to the development of your medical device or its target markets and how to mitigate regulatory risk through effective management of the strategy plan

 
 
Organized by: Regulatory Affairs Professional Society
Invited Speakers:
Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation. Hossack has been in regulatory for more than 20 years, spending the past 11 years at Boston Scientific. His focus has been on international markets, with responsibility for all international regulatory activities outside the US. Hossack’s regulatory career has covered the areas of hazardous goods, medical devices, diagnostics, pharmaceutical and biologics products, always focusing on international markets. Hossack holds a BSc (Hons) from the University of Guelph, Canada.


Patrick Johnson, senior director, regulatory affairs, Medtronic Neuromodulation, has more than 20 years experience in the pharmaceutical and medical device industries, across a variety of pharmaceutical dosage forms and medical devices including combination products. Johnson has more than 15 years of regulatory experience with responsibilities spanning local, state, federal and international regulatory agency requirements. He is currently responsible for deep brain stimulation and emerging therapies within Medtronic Neuromodulation.


Mark Kramer, RAC, president, Regulatory Strategies Inc., has more than 20 years experience in the medical device industry, including 17 years with the US FDA, where he held a variety of review and management positions in the Center for Devices and Radiological Health’s Office of Device Evaluation. He served as the director of the Office of Combination Products from its establishment in 2002 until 2007. Most recently, Kramer served as an executive in regulatory affairs at GE Healthcare before starting his own consulting company. He holds an MS in biomedical engineering from Rensselaer Polytechnic Institute. Kramer serves on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), and is the founder and chair of the Wisconsin RAPS Chapter.

 
Deadline for Abstracts: N/A
 
Registration:
REGISTRATION FEESRegister by 8 FebruaryRegister after 8 February
RAPS Member$1195$1345
Nonmember*$1395$1545
Multiple Members**$1095 each$1245 each
Multiple Nonmembers*$1295 each$1445 each


* 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 18 February 2011 unless meeting capacity is reached; after 18 February 2011, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 8 February 2011
E-mail: acallery@raps.org
 
   
 
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