*Lunch not included with Short Course.
October 25-26: Conference
The DIA Combination Products Conference: Innovation and New Frontiers will examine the current regulatory ecosystem for combination product development and approval, including provisions of the 21st Century Cures Act, proposed PDUFA VI commitments, the implementation of new decision-making models at FDA, US regulatory developments, global regulatory changes, and global alignment efforts. In-depth treatment of digital and eHealth issues, labeling for combination products and complex generics, and CGMPs for combination products will be featured.
In an interactive format, relevant stakeholders from FDA and industry will present the challenges and opportunities in combination product development and life cycle management. Participants will take away today’s best answers to these questions: How can the new legal and regulatory tools be used to best advance combination product development and approval? Is the regulatory framework for combination products good enough and how can it be further improved? How can new technologies be leveraged to realize opportunities in development of new therapies to meet patient needs?
Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.
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Short Course or Primer
To keep you at the forefront.
Rachel Turow, JD, MPH Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Nathan Brown, JD Health Care and Life Sciences Partner
Akin Gump Strauss Hauer & Feld LLP, United States
Carla Cartwright, JD, LLM Director, Federal Affairs
Johnson & Johnson, United States
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Kim Quaintance-Lunn Vice President, US Regulatory Lead, Regulatory Affairs Americas
Bayer AG, United States
John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
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