Sinan Bardakci Sarac, MD, MSc, PhD

Danish Medicines Agency, European Medicines Agency, Denmark

Dr. Sinan Bardakci Sarac holds a medical degree from the University of Copenhagen (Denmark), a M.Sc. (advanced oncology) degree from Ulm University (Germany) and a Ph.D. from the Technical University of Denmark.

He is currently employed as a Chief Medical Officer at the Danish Medicines Agency. He is primarily engaged in clinical assessment (efficacy, safety, and benefit/risk) of medicinal products for oncological and hematological indications for which an application for Marketing Authorisation has been filed to the European Authorities. The Danish Medicines Agency is amongst the leading authorities in Europe in the field of cancer. The medical assessments performed by experts such as Dr. Sarac are the foundation of the decision-making process for marketing authorization of new medicines in the European Union.

He is an expert in the Oncology Working Party (ONCWP) and the Danish member in 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 the European Union 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 has also previously been member of EMA’s Committee for Advanced Medicinal Products (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 Medicines Agency also provides Scientific Advice to developers and academic groups in the field of oncology, in which Dr. Sarac is a regular and engaged participant.