Dimitris Zampatis, MSc, PhD, is an Associate Director, Signal and Risk Management Process at Merck Biopharma. He holds a BSc in Biology, a MSc in Medicinal Chemistry: Drug Design and Development and a PhD in Cell and Molecular Biology.
In his current role he is responsible for the development of the company’s benefit-risk assessment framework, the signal detection strategy e.g. quantitative and qualitative signal detection methods using internal and external databases (EVDAS, VigiBase, FAERS, VAERS, JADER) as also the Risk Management and risk minimization measures processes and implementation.
Through his career Dimitris gained substantial 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.
Dimitris is also a Pharmacovigilance tutor and trainer and participates in various conferences as