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Benefit-risk assessment in Pharmacovigilance and in PBRERs MasterClass with a special focus on PSURs - EU edition

20-21 March, 2024

The training will provide practical advice on benefit risk framework and assessment

Benefit-risk assessment in Pharmacovigilance and in PBRERs MasterClass with a special focus on PSURs - EU edition

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.

 

20-21 March, 2024, Virtual

Time Zone: UTC/GMT+1 /CET

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Overview

 

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.

#masterclass      #glceurope      #pharmaonlinemasterclass    #globalleadingconferences      #benefitriskassessment       #pharmacovigilance     #PBRERs      #PSURs

Trainer
Dimitris Zampatis
Dimitris Zampatis
Global program Safety Lead
Sandoz
Dimitris has got 12 years of experience in providing 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 roles as safety expert, he was responsible for the development of the company’s benefitrisk 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 imgRECOMMENDATION

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

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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12+

Years of experience

399

Events organized

3,710

Speakers

21,521

Attendees

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany