×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Perspectiva general
*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.
Comité del programa
-
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, Head of Regulatory Science and Execution
Alexion, United States -
John Weiner, JD Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
¿Tiene una cuenta?