DIMITRIS ZAMPATIS, Global Program Safety Lead, Sandoz

•   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 is responsible to provide strategic input into safety aspects of assigned product(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.

•   In his previous role as QPPV, he was overall responsible for all pharmacovigilance of all medicinal products for which the company holds marketing authorizations within the EU as also was heading the PV department for the EMEA region. In his previous roles as safety expert, he was 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 and solid knowledge and experience in different aspects of Drug Safety and Pharmacovigilance such as Signal Detection, RMPs, PBRERs/ PSURs, DSURs, safety communications (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 a Pharmacovigilance tutor and trainer and participates in various conferences as a speaker. Also, 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).