Changting Haudenschild, M.D.

Changting Haudenschild, M.D.

Changting Haudenschild, M.D.

Vice President, Technical

Changting’s primary responsibilities at Parexel include formulation of development plans and regulatory strategies for pharmaceutical clients across all phases of product development and preparation of all sizes and complexity of regulatory submissions. A key aspect of strategic advice includes assisting clients in interacting with regulatory agencies to identify areas in which regulatory flexibility and judgment may be applied.

Changting’s in-depth cross-disciplinary regulatory expertise includes clinical safety and efficacy, preclinical development, and biomarker/surrogate endpoint development and utilization. She has indepth experience in avoiding and resolving issues that can otherwise stall development programs and in capitalizing on regulatory initiatives designed to expedite product development.

Changting has experience across the product lifecycle, including preclinical and first-in-human studies, initial marketing applications, postmarketing safety surveillance and supplemental marketing applications. In addition she has broad experience across product types for broad clinical indications, including targeted new molecular entities and biologics (cellular and gene products).

Work Experience

Prior to joining Parexel, Changting was a Medical Officer (Team Leader) at The Office of Tissue and Advanced Therapies, CBER, United States Food and Drug Administration from 2009 to 2018.

Education

Active Medical License in Maryland, USA

Doctor medicinae (Dr. Med.), graduated magna cum laude Medical School, University Münster, Germany

Diploma of Medical Science (M.D.), Harbin Medical School, China

We are always available for a conversation.

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