Sarah Esterquest is a Manager in the CMC Regulatory Affairs at Takeda responsible for providing regulatory strategy and regulatory deliverables on combination products. Prior to Takeda, Sarah worked at Regeneron Pharmaceuticals and CR Bard in various Quality roles where she provided quality assurance and engineering support and guidance to ensure compliance to the requirements of the medical device quality system, focused on combination products for biological therapeutics developed in-house and in collaboration with partners and CMOs.
Sessions
A2: Combination Product Design Control
A2: Q&A with Combination Product Design Control