*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.
Professionals involved in:
- Biopharmaceutical, Device, and Combination Product R&D and Development
- Regulatory Affairs
- Clinical Research
- Consulting, Legal, Government Affairs
- Quality assurance and Control
- Business Development
At the conclusion of this conference, participants should be able to:
- Examine recently issued guidelines and regulations, including FDA’s latest implementation efforts for 21st Century Cures in the combination product space
- Discuss the FDA final guidance for combination product GMPs and identify appropriate mechanisms for resolving GMP-related questions for combination products
- Describe the challenges associated with global registration of combination products and regulatory strategies for navigating differing requirements in different countries
- Explain recent regulatory changes for digital health products and their impact on digital health drug/device combination products
- Identify challenges associated with establishing bioequivalence for generic products, as well as for combination products
Rachel SW Turow, JD, MPH • Executive Counsel, Regulatory Law
Teva Pharmaceuticals Ltd., 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 • Senior Director, Global CMC Medical Devices
Pfizer Inc, United States
Kim M. Quaintance-Lunn • Vice President and Head, US Regulatory Policy
Bayer, United States
John Barlow Weiner, JD • Associate Director, Policy and Product Classification Officer, OCP, OC
FDA, United States