Education Session

103 - Combination Products: Considerations for Entering a New Market

Get Agenda 8 November 13.00-17.00
ISPE CEUs: 0.35


Tracks: SurvivalProductRegulatory

What does it take for pharmaceutical, medical device, and biologics companies to enter the market of Combination Products (CP)? The overlapping elements of traditional pharmaceutical product development stage gates and medical device product development prescribed by design controls create challenges for development scientists, quality, regulatory, and operations professionals in the development of a CP. Using case studies and real-world problem solving techniques, you can learn from the successes and failures of those that have already undergone this process. A representative from the Office of Combination Products will give a presentation from the U.S. FDA’s perspective to give this topic added depth and dimension. The session will conclude with a panel Q&A where participants are encouraged to engage the speakers in lively discussion. Don’t miss out on this exciting session!

This session will focus on:

  • Product development challenges
  • Regulatory Submission Considerations for a CP
  • Case Study: Business Strategy for Entering a New Market (Drug Eluting Stent). Learn how one of the largest device companies positioned themselves to enter the combination product market and the Quality/Compliance considerations that were made.
  • Case Study: Combination Product Development (Ocular Implant). Learn how a multi-specialty health care company focused on discovering, developing and commercializing innovative pharmaceuticals, biologics and medical devices develops a new CP.
  • A comprehensive understanding of the topic through a panel question and answer discussion

How you will Benefit

At the end of this session, participants will be able to:

  • Describe the key phases of CP development
  • Analyze the business, quality system, regulatory, and operational challenges of CPs
  • Understand the business/quality considerations when entering the CP market
  • Appreciate the unique regulatory/submission requirements for CP

Who Should Attend

Quality, compliance, and regulatory professionals, as well as product development scientists

ISPE Communities of Practice (COPs)

GCLP, IP, PPD, and PM

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Rebecca Waterbury, ChE, JD, Regulatory Compliance International, Abbott Vascular Belgium

Session Presenters

  • Steven Koepke, Ph.D., President, SRK Consulting, LLC USA
  • Kristina Lauritsen, Ph D, Senior Scientific Reviewer, FDA USA
  • Philip Russ, Principal Consultant, Innovative Consultants GXP USA
  • Susan Slane, DVP, Global Quality & Compliance, Abbott Vascular USA

Annual Meeting Sponsors