The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants practical advice on RMP drafting and preparation as well the accessors point of view in evaluating an RMP. Moreover, the increasing number of biosimilars and biologicals being authorized highlighted a need to better streamline the safety specification for these products so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. Also, a dedicated section on the risk management aspects of the new GVP guidance on special populations such as children and elderly will be provided.
On the second day participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools, as also on the EMA pilot phase using Eudravigilance Data Analysis System (EVDAS). Regarding signal management using EVDAS, a pilot phase including a limited number of active substances selected based on the list of medicinal products subject to additional monitoring is currently ongoing. During the signal management session, pragmatic approaches, lessons learned, as also processes for signal management and eRMR assessment will be discussed. Finally, during this training an outlook of current and future challenges in pharmacovigilance focusing on the impact of the coming into force of the General Data Protection (GDPR) Regulation in May 2018 will be given and discussed.
- RMP Structure – Learn all the details about the RMP structure and compilation
- Risk Minimization – Discover the risk minimization measures
- Signal Management – Get to know the EU Guidelines and the authorities expectation on Signal Management
- EVDAS – Have a closer look on the signal detection and the MAH experience in EVDAS
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 a speaker.