8:30   –  9:15 AM

Registrations & Refreshments

9:15   –  9:30 AM

Welcome & Chairperson Opening Remarks by Dr. Susan Welsh, SVP, Pharmacovigilance & Chief Safety Officer, Mirati Therapeutics Inc, USA

9:30   –  10:00 AM

Opening Keynote: Regulation Updates and Future Landscapes of PV by Pav Rishiraj, Director and Head of PV, Ipsen

10:00 – 10:30 AM

Audits and Inspections in PV by Tea Babić, Director, Head of PV Audits and Inspections, TEVA

10:30 – 11:00 AM

Tea/Coffee/ Refreshments Networking Break & Exhibition

11:00  –  11:30 AM

Challenges of Compliance in Pharmacovigilance – Is history Repeating Itself? by Michael Bean, Senior Director, Regulatory Compliance at Johnson & Johnson

11:30  –  12:00 PM

The Responsible Application of Large Language models to automate PV case triage and intake by Tim Howard, CEO, Arietta.ai

12:00  –  12:30 PM

Pathfinder Digital Risk Management Platform – what are the advantages in clinical practice? by Mala Nathvani, Heamotology Pharmacist, NHS UK

12:30  – 13:30 PM

Networking Luncheon

13:30 – 14:30 PM

Panel Discussion Topics:
– Patient-Centric Pharmacovigilance: Engaging Patients in Safety Monitoring and Reporting
– Patient-Reported Outcomes (PROs) and Adverse Event Reporting
– Digital Health Tools and Patient Engagement
– Privacy, Confidentiality, and Data Security
– Collaboration between Patients, Healthcare Providers, and Regulatory Agencies

Moderator: Shelley Gandhi

Panelists: Chetan Shatapathy, Mircea Ciuca, Gurpreet Singh

14:30 – 15:00 PM

RMP and PSUR – Any concern about the list of safety concerns? by Mircea Ciuca, PV Thought Leader, Switzerland

15:00 – 15:30 PM

Afternoon Tea/ Refreshments Networking Break/ Exhibition

15:30 – 16:00 PM

Regulatory Affairs in PV Audits by Mateja Pranjic, PVQA, GSK

16:00 – 17:00 PM

ROUND TABLE DISCUSSIONS 

17:00 – 18:00 PM

Chairperson Closing Remarks & Networking Drinks Reception