Tea Babić
Teva Pharmaceuticals
Director, Head of global PV audits and inspections, Deputy Head PV Compliance
Onsite vs. remote vs. hybrid audits and inspections
With pandemic measures being lifted and life going back to "normal", there is an increased trend of hybrid audit and inspection models. The session will investigate recent experiences, and inspection and audit practices used by inspectorates and auditors worldwide.
Robert Di Giovanni
Novartis
Global Patient Safety Lead
Adverse Events in Digital Age
- Digital healthcare.
- Explosion of data.
- Is there a need to screen digital health data for adverse events (AE)?
- How to screen data for AEs?
- How to define ae from digital data sources?
Prashant Joshi
Labcorp Drug Development
Executive Director, Drug Safety
New Age Pharmacovigilance: New and Emerging Therapies and PV Readiness
- New therapies and innovative technologies in medicine
- Use of cognitive intelligence in PV, emerging trends
- Key challenges and preparedness.
Gloria Bustos
Baxter Healthcare
Snr. Director, Head of Pharmacovigilance EMEA and Asia Pacific
China GVP and Global Impact
- China PV regulatory overview.
- GVP implementation learnings and challenges.
- Impact on global PV.
- What is next? Some insights.
Karsten Lollike
Novo Nordisk
Corporate Vice President and QPPV
The role of the QPPV
- The role of the QPPV
- Oversight
- Delegation
- Handover to substitute
Garry Flounders
Biogen
Senior Process Lead
Pharmacovigilance Oversight: Ensure Streamline Communication Between Partners, CROs, and Sponsors.
- Communication is key! Make sure everyone is on the same page and has updated information.
- Call centers, outsourced partners, off-site teams, vendors, and everyone involved need to be on the same page and need to have a clear understanding of their roles and responsibilities when facing an inspection.
- Notify proactively when an inspection or an audit is taking place to provide time and opportunity to have all the information required available.
A methodical strategy to recognise, evaluate, comprehend, respond to, and articulate medication safety and risk issues. Drug safety and risk management have evolved over the last centuries, and there have been several tragedies to learn from to protect patients. As with any medication, there are risks associated with its use, including the possibility of adverse reactions, interactions with other medications, and the risk that the product may not function as effectively as anticipated. Pronovea is bringing together pharmacovigilance pioneers and healthcare innovators to discuss and exchange best practices and strategic insights and to collaborate to enhance drug safety and risk management.