Dr. Balamotis joined DSI - London as Managing Director, EU Regulatory Affairs in 2014 and in 2018 was promoted to President, EU Regulatory Affairs. Prior to joining DSI, he was a Scientific Administrator for the European Medicine Agency’s (EMA) Name Review Group (NRG). NRG is responsible for evaluating and approving invented names submitted to the Agency via the centralized procedure. He played an integral role in the development of the EMA’s 2014 NRG Guidelines, which were published in May 2014. Dr. Balamotis reported directly to the EMA’s NRG Secretariat during his tenure with the agency. He participated in all name review meetings and communicated meeting outcomes with NRG affiliates. And, while working on the 2014 guidance document, he liaised with Member States and representatives of the Pharmaceutical Industry, coordinating information and input from all relevant parties. He assisted the EMA in conducting technical reviews of the Product Information (Summary of Product Characteristics, Labeling and Package Leaflets) according to QRD (Quality Review of Documents) standards and in evaluating mock-ups and specimens (packaging artwork). He was also involved in the implementation of the new Pharmacovigilance Legislation, which involved the electronic submission of substance data according to ISO IDMP standards in the first EMA’s electronic medicinal dictionary (XEVMPD).
Dr. Balamotis is a current member of the BHBIA (British Healthcare Business Intelligence Association) Ethics & Compliance Committee.
Dr. Balamotis earned his Doctor of Pharmacy from Carlo Bo University of Urbino, Italy and a B.Sc. in Chemistry at Aristotle University of Thessaloniki, Greece.