NEWS – Pharmacovigilance Advanced Learning New Webinar
Published 7 October 2021.
We invite you to join our next free educational webinar titled “Pharmacovigilance Advanced Learning: Aggregate Reports Guidance”.
Part of our “Pharmacovigilance Advanced Learning” webinar series, this new webinar aims for our experts to present and provide our listeners with a good understanding of Aggregate reports. Our webinar will guide you through Aggregate report types, planning, content, and current legal requirements, helping our listeners gain the knowledge and support in the preparation of Aggregate reports throughout the lifecycle of the medicinal product.
Choose between one of 3 sessions available for this webinar:
Session 1: 27 October, 6am EST / 11am GMT / 12pm CET
Session 2: 27 October, 10am EST / 3pm GMT / 4pm CET
Session 3: 27 October, 2pm EST / 7pm GMT / 8pm CET
Who should attend:
Pharma employees interested in learning more about aggregate reports and reporting requirements for medicinal products
Introduction of the Aggregate reports types
Overview of different types of Aggregate reports: DSUR, PSUR/PBRER, PADER/PAER, ACO
In-depth look into the legal framework
Q&A session as time to ask our experts any questions
About our expert speakers:
Dr. Vjera Bilušić Vundać Director of Medical Writing, PrimeVigilance
Vjera has over 20 years of experience in scientific pharmaceutical research, pharmacovigilance, regulatory affairs, and quality and spent the last decade in managerial and directorial roles in both the pharma industry and pharma service providers. Her experience includes working with all range of medicinal products, from generics to originals, biosimilars, vaccines, and blood derivates, covering both safety and regulatory aspects of medicinal product life-cycle.
Jana Dančíková, MD Strategic Advisor, PrimeVigilance
Jana has over 14 years of experience in pharmacovigilance, mainly in preparation of periodic safety reports and signal detection. She has worked with several global pharmaceutical companies as well as service providers. She joined PrimeVigilance in 2020 and currently holds the position of Strategic Advisor, working closely with the Medical Writing Department.
If you have any questions about our webinar please feel free to contact us