Signal and Risk Management in Pharmacovigilance - US edition MasterClass
06-09 March, 2023
The focus of this four days pharma online masterclass will be on providing an update of ongoing activities regarding medicines’ risk and signal management.
The focus of this four days Signal & Risk Management in Pharma online MasterClass training will be providing an update of ongoing activities regarding medicines’ risk and signal management. This Training also provides the practical advice on RMP drafting and preparation.
06-09 March, 2023, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
The focus of this three days Signal & Risk Management in Pharmacovigilance online training will be providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide thepractical advice on RMP drafting and preparation. The second day participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools.
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In his current role he provides guidance and advise on the business development strategy in Pharmacovigilance areas and services, strategic input into safety aspects of assigned project(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.
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 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. He was also responsible for the development and implementation of new safety strategies and tools within signal and risk management as also benefit-risk assessment frameworks.
Dimitris is a Pharmacovigilance tutor and trainer and participates in various conferences asa speaker. Moreover, 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).
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
"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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