Benefit-risk assessment in Pharmacovigilance and in PBRERs MasterClass with a special focus on PSURs - US edition
22-23 February, 2024
The training will provide practical advice on benefit risk framework and assessment
The focus of the Periodic and Benefit Risk Evaluation Reports (PBRERs) two day online training will be providing an update of ongoing activities regarding periodic safety evaluation and review of the benefit risk of medicinal products.
22-23 February, 2024, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
The focus of the Periodic and Benefit Risk Evaluation Reports (PBRERs) two day online training will be providing an update of ongoing activities regarding periodic safety evaluation and review of the benefit risk of medicinal products. The training will provide practical advice on benefit risk framework and assessment and how it is used in the writing and preparation of PBRERs. During the training a holistic approach and practical examples on the connection between signal and risk management with PBRERs will be given.
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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).
Dimitris is biologist by training, acquired a MSc in Medicinal Chemistry from University of Patras in Greece, a MSc in Health Policy and Planning from the Open University of Cyprus and he holds a PhD in Cell and Molecular Biology from Free University of Berlin.
Who should attend?
• Safety experts
• Periodic safety reporting
• Risk management planning and development of formal Risk Management Plans/REMS
• Medical writers
• Regulatory strategy and regulatory affairs
• Clinical research
• Medical Affairs
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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Years of experience
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