On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.

Niedre discusses:

Key Topics

• Challenges with global regulatory strategies for combination products
• Impact of regulatory strategies on patients and product adoption
• Becoming an FRAPS, and building wide expertise in QA & RA
• Being a great teammate/colleague

Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise in public health to bring a uniquely patient centric point of view.