Clinical & Regulatory Strategies for Combination Products

Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will be giving the state of the industry address at Q1 Productions’ 2nd Annual Clinical & Regulatory Strategies for Combination Products, which is slated to take place in Baltimore, Maryland from July 11-12, 2011.  The potential benefit of combination products is significant for companies looking to provide cutting edge healthcare solutions and maintain a competitive edge.  These complex products have been cause for much regulatory discussion and interpretation since their inception and have thus been surrounded by uncertainty.  The conference will bring together not only industry representatives that have successfully navigated FDA’s combination product approval processes, but will also bring the Agency to the table to discuss and clarify processes and procedures for obtaining regulatory approval for these challenging products.

Topics to be covered at the conference include:

• State of the industry address: recognizing the past, present and future of combination products
• Exploration of various FDA approval pathways available for combination products
• Comparison of drug vs. device vs. combination approval routes
• Question & answer period with FDA executives, roundtable discussion
• Understanding timelines for data submission and approvals
• Development of strong working relationships with the FDA and internal teams
• Trial design strategies that ensure clinical data will support regulatory clearance
• Securing optimal data from clinical sites and labs based on regulatory path
• Establishing safety and efficacy of combination products
• Case study presentations focusing on various types of combination products
• Utilization of clinical data to support reimbursement goals
• The use of combination products in furthering personalized medicine
• Differences in approval routes for products containing a cleared product
• Opportunities in comparing similar products and establishing precedents
• Post-market concerns in adverse event reporting and surveillance
• International regulatory considerations and clearance routes
• Strategies in conducting international combination product clinical studies
• Manufacturing and quality assurance considerations for combined products
• Creating meaningful partnerships to support combination product commercialization
• Understanding and utilizing guidance documents released by the FDA
• Deciphering and complying with current good manufacturing practices

Mr. Shapiro’s presentation will focus on overcoming clinical and regulatory hurdles for combination products.  In particular, Jeff’s presentation will focus on:

• A thorough definition of combination products
• Historically important combination products & impact on regulations
• Current state of the combination products industry
• Methods for furthering commercialization
• Strategies for clinical & regulatory teams to get products to market

Additional information about the conference, including registration information, is available here.