In an increasingly complex and global pharmacovigilance environment, the need for more effective and easier collaboration is accelerating adoption of cloud technologies. Seamlessly incorporating internal / external parties into end-to-end processes and providing a single source of safety data and content, drives greater efficiencies while improving compliance, data quality, and global visibility.
See how a cloud-based approach to managing safety content balances control with autonomy – streamlining authoring, review, and sharing of content across teams and with partners while providing greater transparency and oversight. Many companies are leveraging modern content management solutions to easily scale and meet the growing number of regions requiring a pharmacovigilance system master file (PSMF) or equivalent documentation.
Join us as we discuss:
- Challenges and impact from regulatory trends on managing safety content
- How cloud-based solutions supports collaboration across teams and different outsourcing models
- Real-world use case on easily complying with global / regional requirements for pharmacovigilance system master file (PSMF) leveraging cloud-based PV solution
- Strategies for moving to cloud-based safety applications
David Kolosic, Senior Manager, Safety Strategy, Veeva Systems
David Kolosic is a Senior Manager for Vault Safety Strategy at Veeva and has almost a decade of experience in multiple disciplines, including pharmacovigilance, quality management, regulatory information management and business development. He has helped pharma companies transform departments to become more efficient, collaborative and ultimately successful with modern technologies. David holds a Bachelor of Science (BSc), Pharmaceutical Studies (Hons) and a Master of Science (MSc), Pharmaceutical Science and Management Studies from Kingston University, London, UK.
Emanuela Leone, Solution Consultant, Safety, Veeva Systems
Emanuela Leone is a Solution Consultant for Vault Safety at Veeva. She’s a Doctor of Pharmacy (PharmD), holds a Master in Regulatory Affairs and a Master in Pharmacovigilance and Drugs Safety. She has over 15 years of experience in clinical trials, pharmacovigilance, and quality management in both public and private sectors. She helped multiple pharma companies understand how to best leverage modern pharmacovigilance solutions.
Who Should Attend?
This webinar will benefit those involved in pharmacovigilance, with relevant areas of expertise and job titles, including:
- Biosafety Professionals
- Safety Managers
- Risk Managers
- Regulatory Specialists
- Heads of Pharmacovigilance (PV)
- Heads of Pharmacovigilance (PV) IT
- Heads of Safety Operations
- Safety Specialists
- EU QPPV
- Safety Scientists
- Aggregate Report Specialists
- PV Agreements Specialists
- PSMF Coordinators
- Medical Reviewers
What You Will Learn
- Regulatory trends impacting management of safety content
- How to enable greater collaboration and oversight across teams and for different PV outsourcing models with a cloud-based safety solution
- Best practices on easily meeting global / regional requirements for pharmacovigilance system master file (PSMF) with a modern approach
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,100 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit www.veeva.com/eu.