In today's rapidly evolving healthcare landscape, the significance of signal management in pharmacovigilance cannot be overstated. At the core of drug safety, signal management stands as a crucial process for the early detection of potential risks associated with pharmaceutical products. It is a dynamic and critical discipline, pivotal for maintaining public health and ensuring patient safety. Recognizing this essentiality, our Signal Management Excellence in Pharmacovigilance Masterclass emerges as a vital resource for professionals in the field.
This comprehensive 2 half-day training is thoughtfully curated to address the growing complexities and evolving demands of drug safety monitoring. By marrying theoretical foundations with practical applications, the course offers an unparalleled deep dive into the mechanisms and methodologies of signal detection and management. Participants will be guided through the nuances of global guidelines, best practices, and innovative tools, gaining insights crucial for navigating the intricate landscape of pharmacovigilance.
More than just a learning platform, this course is a journey towards mastering the art and science of signal management. Attendees will explore the integral role of signal management in safeguarding patient health and the consequences of its neglect, highlighting its undeniable relevance in the present-day medical field. From understanding the implications of signal detection on drug labelling and regulatory compliance to mastering communication with health authorities, the course encapsulates every aspect necessary for excelling in this vital domain.
.webp)
Foundational Knowledge: Acquire a solid understanding of the principles, basic definitions, and frameworks for signal management
Comprehensive Signal Management Skills: Develop skills in both qualitative and quantitative signal management techniques, directly applicable to those in drug safety roles.
GVP Module IX Expertise: Understand the Good Pharmacovigilance Practice Module IX from the Marketing Authorization Holder's perspective.
Case Study Analysis: Delve into case studies focusing on real-life scenarios, enhancing your decision-making and strategic skills in pharmacovigilance.
Insights into EVDAS and eRMR Analysis: Gain proficiency in using EVDAS for signal detection, crucial for those working with electronic health records and drug safety databases.
Effective Safety Communication: Enhance your ability to communicate about signals, Emerging Safety Issues, and DHPCs to regulatory authorities.
In-Depth Exploration of Signal Management: Delve into the specificities of signal management, a cornerstone in pharmacovigilance.
Compliance Mastery: Navigate the complex regulatory landscape with ease. Gain insights into how signal management plays a key role in meeting audit and inspection requirements.
Effective Variation Monitoring: Learn strategies for monitoring and implementing variations in signal management, key for maintaining product safety and compliance.
Advanced Analytical Techniques: Learn cutting-edge quantitative methods including data mining and EVDAS analysis.
Real-World Applications and Case Studies: Engage with practical, industry-relevant scenarios that simulate the challenges and decision-making processes you face in your role.
Audit and Inspection Preparedness: Learn how signal management impacts compliance in audits and inspections.
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.
