Sinan Bardakci Sarac, MD

Danish Health and Medicines Authority, European Medicines Agency.

Dr. Sinan Bardakci Sarac is employed as a Senior Medical Officer in the Section for Medical and Toxicological Assessment, Division Medicines Licensing and Availability at the Danish Health and Medicines Authority. He is primarily engaged in clinical assessment (efficacy, safety, and benefit/risk) of medicinal products for oncological indications for which an application for Marketing Authorisation has been filed to the European Authorities. The Danish Health and Medicines Authority is amongst the leading authorities in Europe in the field of oncology. The medical assessment performed by expert assessors such as Dr. Sarac is the foundation of the decision-making process for marketing authorization of new medicines in Europe.

He is an expert in the Oncology Working Party of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). All oncology products mandatorily have to undergo this centralized European marketing authorization procedure, and the CHMP is the main body in Europe for decisions as regards recommendations for marketing authorizations for human medicines. Its Oncology Working Party is a key advisor to the Committee in scientific and regulatory questions around oncology medicines, and is key in drafting the Committee’s scientific guideline on anticancer medicines.

Dr. Sarac is also the Danish member in EMA’s Committee for Advanced Therapies (CAT). This committee is gathering together some of the best European experts to assess the quality, safety and efficacy of advanced therapy medicinal products (ATMPs, i.e., gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineering) and to follow scientific developments in the field.

The Danish Health and Medicines Authority also provides Scientific Advice on a national basis to developers and academic groups in the field of oncology, in which Dr. Sarac is a regular and engaged participant.