082 – CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman

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

Common Technical Document
Combination Products Structure for eCTD Submissions
EU vs. US Submission Expectations
Design Controls and Human Factors data placement
Regulatory Roles and Responsibilities in Pharma

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.