Advanced Signal Management in Pharmacovigilance MasterClass - EU edition
04-05 March, 2024
A holistic approach and practical examples on the connection between signal/risk management with benefit risk and PBRERs
The training will provide practical advice on signal management methods (qualitative/quantitative), assessment and how it is connected in the writing and preparation of PBRERs and RMPs.
04-05 March, 2024, Virtual
Time Zone: UTC/GMT+1 /CET
The focus of the Advanced Signal Management in Pharmacovigilance two half days online training will be providing a holistic and a more detailed approach on activities and processes regarding ongoing safety evaluation and review of the benefit risk of medicinal products while performing signal detection and management. The training will provide practical advice on signal management methods (qualitative/quantitative), assessment and how it is connected in the writing and preparation of PBRERs and RMPs. Thus, during the training a holistic approach and practical examples on the connection between signal/risk management with benefit risk and 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 physicians /scientists
• Pharmacovigilance experts
• Medical writers
• Safety Risk managers
• Signal management experts
• Clinical safety scientists
"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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