In the ever-evolving field of pharmacovigilance, understanding the delicate balance between the benefits and risks of medicinal products has always been paramount. Historically, the industry has continuously adapted to emerging data and patient experiences to ensure the safety and efficacy of drugs. In this spirit, our 2 half-day online masterclass, "Pharmacovigilance Excellence: Advancing Benefit-Risk Proficiency in PBRERs" is designed to provide a deep dive into the critical aspects of Periodic Benefit-Risk Evaluation Reports (PBRERs) and safety reporting.
This comprehensive training bridges the historical foundations of pharmacovigilance with contemporary practices. It is tailored to a diverse audience, ranging from professionals new to the field to experienced practitioners looking to refine their skills. The curriculum covers not only the fundamental principles and frameworks of benefit-risk assessment but also provide insights into the regulatory perspectives of major bodies such as the FDA and EMA. A significant focus of the course is the integration of patient perspectives into the benefit-risk process, a crucial aspect that enhances the relevance and impact of pharmacovigilance activities.
Participants will delve into the structure and compilation of PSURs, understand the interplay between signal detection and PSURs/PBRERs, and distinguish between PSURs and Development Safety Update Reports (DSURs). The course also explores the relationship between Risk Management Plans (RMPs) and PSURs, providing a comprehensive view of drug safety reporting. The learning experience is enriched with interactive sessions, including case studies and group discussions, ensuring that the theoretical knowledge gained is anchored in practical scenarios. These interactive elements are designed to build skills in team management, data analysis, and effective communication, which are key in navigating the complex landscape of pharmacovigilance.
By the end of this masterclass, participants will have a well-rounded understanding of benefit-risk assessment in pharmacovigilance, equipped with the tools and knowledge to make a significant impact in their professional roles. This training is more than just a learning opportunity; it's a step towards shaping the future of drug safety and enhancing patient care in the pharmaceutical industry.
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Master the Foundations: Delve into the essential principles, terminologies, and structural frameworks crucial for understanding benefit-risk in pharmacovigilance. Embark on a journey to decode the complexities of this vital aspect in drug safety.
Core Techniques of Assessment: Develop a robust skillset in executing thorough benefit-risk assessments. Learn to navigate through the nuances of evaluating medicinal benefits against potential risks, a key component in pharmacovigilance decision-making.
Patient-Centric Approaches: Elevate the role of patient perspectives in your assessments. Understand the significance of integrating patient experiences and feedback into the benefit-risk evaluation process, enriching the quality and relevance of your assessments.
Guideline Proficiency: Gain expert knowledge in Good Pharmacovigilance Practices (GVP), particularly Module VII, which governs Periodic Safety Update Reports. Enhance your understanding of these critical guidelines to ensure compliance and excellence in report submissions.
Navigating Legal and Regulatory Frameworks: Acquire a comprehensive understanding of the legal and regulatory landscapes that shape PBRER. Learn how to align your reports with these requirements, ensuring they meet the highest standards of regulatory scrutiny.
Navigating Legal and Regulatory Frameworks: Acquire a comprehensive understanding of the legal and regulatory landscapes that shape PBRER. Learn how to align your reports with these requirements, ensuring they meet the highest standards of regulatory scrutiny.
In-Depth Benefit-Risk Analysis: Sharpen your skills in conducting detailed benefit-risk assessments specifically for PBRERs. Understand the critical elements that contribute to a well-rounded and thorough evaluation
Linking Signals with Risk Management: Unravel the complex interrelationships between signal detection, Risk Management Plans (RMPs), and PBRERs. Learn how to weave these components together to create a cohesive and comprehensive safety profile for medicinal products.
Dr. Dimitris Zampatis is an accomplished pharmacovigilance professional with over 12 years of experience in the field. His expertise includes leading safety reviews, developing pharmacovigilance processes, and contributing to signal and risk management. Known for his adeptness in audits and inspections, Dimitris has been integral in developing benefit-risk assessment frameworks and signal detection strategies, utilizing databases like EVDAS, VigiBase, and FAERS.
His career encompasses significant roles in risk management and implementing safety measures, with a deep understanding of Drug Safety, RMPs, PBRERs/PSURs, and DSURs. Dimitris has also made notable contributions to FDA and EMA submissions, both as a team member and leader.
In academia, he serves as a Pharmacovigilance tutor and trainer, a speaker at various conferences, and a guest lecturer in the MSc program in Drug & Regulatory Affairs at the University of Nicosia, Cyprus.
Dr. Zampatis holds a Master's degree in Medicinal Chemistry from the University of Patras, Greece, and in Health Policy and Planning from the Open University of Cyprus, alongside a Ph.D. in Cell and Molecular Biology from the Free University of Berlin. He is currently the Global Program Safety Lead at Sandoz, Germany.
