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About This 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.

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
Language: English
Who can attend? Anyone with the event link can attend
Featured Presenters
Webinar hosting presenter
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.
Webinar hosting presenter
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.
Webinar hosting presenter
PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 13 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.

From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
• 750+ highly qualified professionals
• Global leader in QPPV services
• 24/7 multilingual call center
• Choice of leading drug safety databases
• Robotic Process Automation (RPA) expertise
• Access to regulatory experts and key opinion leaders

GLOBAL LIFE CYCLE MANAGEMENT SERVICES
• PHARMACOVIGILANCE
• PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT
• AUDIT & INSPECTION
• QUALITY MANAGEMENT
• REGULATORY SCIENCE

www.primevigilance.com
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BioAlliance Video Network webinar platform hosts Pharmacovigilance Advanced Learning: Aggregate Reports Guidance
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