When seamlessly collaborating with partners on the same cloud-based safety solution, sponsors have real-time visibility and control while driving more efficient and faster processes. Easily scaling with more studies or data, modern pharmacovigilance (PV) applications are intuitive and designed for teams to work together globally.
Sponsors and CROs / service providers often have separate safety systems, or for smaller biotechs / pharmas, only use the partner’s solution. With limited to no direct system access for external users, there is significant overhead to support oversight, audits and inspections. Safety application owners must frequently generate reports and send them to all parties for visibility, with reporting delays potentially impacting decision-making and proactive action. By reducing manual overhead for outsourcing processes, PV teams can better scale the increasing number of adverse events, data sources and regulatory requirements.
Cloud technologies provide transparency for all stakeholders and simplify safety processes. Sponsors and CROs / service providers can easily and securely access or share information, participate in PV activities and track tasks. With greater visibility and scalability, sponsors and partners can build trust and easily establish a successful and efficient working relationship.
Join this webinar to learn more about outsourcing pharmacovigilance while maintaining control and visibility.
Janelle Ibsen, Director, Patient Safety and Pharmacovigilance, Parker Institute for Cancer Immunotherapy
Janelle has over 12 years of experience in drug safety and pharmacovigilance at small and large biotech companies. Currently at Parker Institute for Cancer Immunotherapy (PICI), she is responsible for patient safety and pharmacovigilance and safety outsourcing. Prior to PICI, Janelle was the Senior Manager of Pharmacovigilance at Clovis Oncology and Drug Safety Manager at Medication.Message Presenter
Kelly Traverso, VP Vault Strategy, North America, Veeva Systems
Kelly has over 20 years of industry and consulting experience supporting biotech and pharmaceutical companies. At Veeva, she is responsible for safety strategy and customer success for North America and has extensive knowledge and experience with the US FDA, and EMA safety and quality regulations. Kelly has applied specialized knowledge of regulatory and compliance to business processes across the life sciences. She has developed strategies, designed and redesigned processes, supported technology implementations, and defined governance across the spectrum of pharmacovigilance activities. Her in-depth industry knowledge helps clients stay aligned with industry-leading practices and remain competitive in the marketplace.Message Presenter
Who Should Attend?
- Biosafety Professionals
- Safety Managers
- Risk Managers
- Regulatory Specialists
- Heads of Pharmacovigilance
- Heads of Pharmacovigilance IT
- Heads of Safety Operations
- Safety Specialists
- European Union (EU) Qualified Person for Pharmacovigilance (QPPV)
- Aggregate Report Specialists
- Pharmacovigilance Agreements Specialists
- Pharmacovigilance System Master File (PSMF) Coordinators
- Medical Reviewers
What You Will Learn
Attendees will learn:
- Challenges and strategies to strengthen collaboration between sponsors and partners
- Best practices for improving oversight and operational effectiveness
- Key reports and metrics to support alignment
- Ways modern technology is transforming pharmacovigilance
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.
- Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry
- Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers
- Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America