Learning outcomes

Training description

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.

Training schedule

Day one

  • 09:00 EU guidelines on risk management: some background

  • 10:00 RMP structure and compilation

  • 11:00 Break

  • 11:15 Assessing RMPs and RMP quality indicators

  • 12:15 Effective risk communication (HA, patient and MAH perspectives)

  • 13:00 Lunch Break

  • 14:00 Handling of Risk Minimization measures

  • 14:45 RMP for Biosimilars and biologicals

  • 15:30 Break

  • 15:45 RMP for special populations (pediatrics, elderly and pregnant women)

  • 17:00 End of day 1

Day two

  • 09:00 EU Guidelines on Signal Management-background

  • 10:00 Authorities expectation on Signal management

  • 11:00 Break

  • 11:15 Signal management and inspections

  • 12:15 Performing Signal Detection (examples and best practices)

  • 13:00 Lunch Break

  • 14:00 Data mining using regulatory databases

  • 14:45 Signal detection in EVDAS (eRMR analysis, generis and innovative products)

  • 15:30 Break

  • 15:45 MAH experience in EVDAS (lessons learned)

  • 16:45 GDPR in Pharmacovigilance-what is new for MAHs?

  • 17:30 End of day 2

Training Program

Download detailed Agenda - Risk & Pharmacovigilance MasterClass

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Get to know the Expert Trainer

Dimitris Zampatis
Dimitris ZampatisAssociate Director, Signal and Risk Management Process at Merck Biopharma

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.

Who should attend?

• Individuals involved in risk management planning, risk minimisation development and post authorisation safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
• Risk communication experts
• Qualified Persons responsible for Pharmacovigilance (QPPVs)
• Individuals involved in pharmacovigilance, safety database, signal management and information management

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