Hardware Podcasts

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

Let's Combinate · 26 Apr 2023 · 43m

What this episode covers

Niedre Heckman, Director of Regulatory Affairs Strategy at Takeda, explains the Common Technical Document (CTD) structure for combination products, detailing the five modules and the specific placement of device information in Module 3.2R versus drug manufacturing in 3.2P. She contrasts US and EU submission expectations, noting the EU's more prescriptive guidance on where device data belongs, and describes how regulatory organizations structure their teams around CMC, publishing, and policy. The discussion covers the lifecycle of submissions, including rolling submissions, human factors data placement in Module 5, and the use of Drug Master Files (DMFs) as references.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Takeda
Also
CTD, FDA, EMA, ICH, DMF

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