Regulatory Approvals & Clinical Research for Combination Products Conference

Navigating the Unclear Regulatory Pathways for Combination Products, Assuring Adequate Clinical Data is Obtained for Regulatory & Reimbursement Approvals

July 12-13, 2010
Baltimore, MD

 

About the Conference

 

As combination products have continued to increase in complexity and popularity throughout the pharmaceutical and medical device industries, so have the challenges associated with obtaining regulatory approval for these often very unique and specialized products. Although the FDA has many processes in place for the approval of medical devices and pharmaceutical products, the pathway for combination products is often not as transparent, causing confusion and frustration within the industry. This conference program will bring together not only industry representatives that have successfully navigated approval processes with the FDA, but will also bring the agency to the table to discuss and clarify processes and procedures for obtaining regulatory approval for these challenging products.

Presenters to Include

 

Kimberly Snyder

Senior Manager, Global Quality System and Processes
F. Hoffman-La Roche Ltd

 

Ian Purdy
Vice President, Regulatory Affairs
Boston Scientific

 

Invited FDA Speaker

Patricia Love, MD, MBA

Deputy Director
FDA Office of Combination Products

 

And More...

 

 

Topics to Include

 

• Realizing the commercial potential of combination products for various therapeutic areas
  
• Defining the regulatory path for all manner of complex combination products
  
• Working with the FDA in order to have a full understanding of regulatory requirements
  
• Case studies exhibiting successful navigation of the FDA regulatory approval process
  
• Development of clinical research studies that meet regulatory requirements
  
• Utilization of individual product clinical data as well as combination trial data
  
• Building health economics end points into clinical studies to support reimbursement
  
• Adverse event reporting: processes and clarifications
  
• Creating strong partnerships to support combination product commercialization
  
• Bringing together diverse clinical and regulatory paths to assure approvals
  
• Use, protection, and leverage of IP and patents in combination product development
  
• Regulatory requirements on a global level for combination products
  
• Pre-clinical challenges for combination products, understanding requirements
  
• Post-marketing considerations for combination products and post-marketing research
  
• Navigating the scientific and regulatory divide separating drugs and devices
  
• Novel case studies of unique first-in-man combination products
  
• Assuring product cost-effectiveness through thorough and insightful research studies
  
• Working with CROs and regulatory consultants to assure product approvals
  
• Global clinical and regulatory considerations specific to combination products

And More...

 

 

To request the full two-day conference agenda, information on promotional pricing & registration details please contact:
Paul Hernandez, Marketing Manager
phernandez@Q1productions.com
312-602-9684