Signal and Risk Management in Pharmacovigilance - US edition MasterClass

He holds a BSc in Biology, a MSc in Medicinal Chemistry: Drug Design and Development, a MSc in Health Policy and Planning and a PhD in Cell and Molecular Biology.

In his current role he provides guidance and advise on the business development strategy in Pharmacovigilance areas and services, strategic input into safety aspects of assigned project(s), lead the pharmacovigilance processes and product safety reviews, review SOPs and guidelines, provide scientific input in signal, risk management and benefit risk assessment
outputs and reviews and act as key person for regulatory or internal audits and inspections.

Through his career Dimitris gained substantial and solid knowledge and experience in different aspects of Drug Safety and Pharmacovigilance such as Signal Detection, RMPs, PBRERs/ PSURs, DSURs, safety communication (e.g. Direct Healthcare Professional Communication/ Dear Investigator Letter). He participated in various successful FDA and EMA submission applications either as a team member or as team leader. He was also responsible for the development and implementation of new safety strategies and tools within signal and risk management as also benefit-risk assessment frameworks.

Dimitris is a Pharmacovigilance tutor and trainer and participates in various conferences asa speaker. Moreover, Dimitris is a guest lecturer at the Master of Science (MSc) program Drug and Regulatory Affairs of the Pharmaceutical Department of the University of Nicosia (Cyprus).