NEWS – Pharmacovigilance Advanced Learning New Webinar

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:

• HCPs
• Pharma employees interested in learning more about aggregate reports and reporting requirements for medicinal products

Agenda:

• 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