Dr. Sinan B. Sarac, MD, MSc, PhD

Dr. Sinan B. Sarac, MD, MSc, PhD

Dr. Sinan B. Sarac, MD, MSc, PhD

Vice President, Technical

Sinan has more than 10 years of experience within the EU regulatory system. His main therapeutic expertise is in oncology and hematology. However, as a physician and longstanding member of CHMP, Dr. Sarac has solid experience across many therapeutic areas, including innovative therapies, rare diseases, and biosimilars. He has actively participated in the committee’s work and has been an integral part of drafting and reviewing regulatory policy and clinical guideline documents. 

He has attended +100 plenary meetings in CHMP, CAT, and SAWP and participated in countless Oral Explanations in CHMP and CAT.

His expertise and professional experience from the Danish Medicines Agency and the EMA make him an expert in the development and approval of medicinal products, an expert in scientific advice and navigating the European regulatory system.

Work experience

Sinan has served as a member of CHMP (2015-2022), CAT (2013-2015), SAWP (2017), and ONCWP (2014-2022) at the European Medicines Agency (EMA). He has also been Chair of ONCWP (2019-2022) before joining Parexel.

Sinan has also served as Chief Medical Officer at the Danish Medicines Agency, where he was overall responsible for the scientific evaluation of new cancer products, extension of indications, national scientific advice (cancer products), etc.

Education

Sinan holds a Ph.D. from The Technical University of Denmark (DTU) and Novo Nordisk A/S, an MD from the University of Copenhagen, Denmark, and a MSc in Advanced Oncology from Ulm University, Germany.

He has published several peer-reviewed papers in the field of oncology, hematology, regulatory science, nephrology, and epilepsy.

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