About Us

Ioannis (Nakos) Balamotis, B.Sc., Pharm.D.
Managing Director, EU Regulatory Affairs

Dr. Balamotis joined DSI - London in September of 2014 after serving as a Scientific Administrator for the European Medicine Agency’s (EMA) Name Review Group (NRG), the division that 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 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 review 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 Committee.

Dr. Balamotis earned his Doctor of Pharmacy from Carlo Bo University of Urbino, Italy and a BSc in Chemistry at Aristotle University of Thessaloniki, Greece. He is fluent in Greek, Italian and English with advanced comprehension of German and Spanish.

DSI Executive Team

Recent Healthcare Approvals

Back to top