Conference Program

PV EUROPE 2024

Agenda

15 – 16 May 2024

15 May – Day One Agenda

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 Mijal Chavda, Senior Director, Global Head of GxP Inspections & GVP Quality at Kyowa Kirin International plc

10:30 – 11:00 AM

Tea/Coffee/ Refreshments Networking Break & Exhibition

11:00  –  11:30 AM

Topic TBC 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

Health Beacon Speaking Slot

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: Pav Rishiraj

Panelists: Chetan Shatapathy, Mircea Ciuca, Gurpreet Singh, Stephanie Jones

14:30 – 15:00 PM

Gold Sponsor Speaking Slot (Available)

15:00 – 15:30 PM

Afternoon Tea/ Refreshments Networking Break/ Exhibition

15:30 – 16:00 PM

Regulatory Affairs in PV by Mateja Pranjic, PVQA, GSK

16:00 – 16:30 PM

TOPIC TBC | Dr. Mircea Ciuca, PV Thought Leader, Switzerland

16:30 – 17:30 PM

ROUND TABLE DISCUSSIONS 

17:30 – 18:30 PM

Chairperson Closing Remarks & Networking Drinks Reception

16 May – Day Two Agenda

08:30   –  9:15 AM

Registrations & Refreshments

09:15   –  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

Risk Management by Emmanuel Lohrmann, Lead Saftety Physician, Otsuka Pharmaceuticals GMBH

10:00   –  10:30 AM

TOPIC TBC | Tahira Jan | Medicines and Healthcare products Regulatory Agency (MHRA)

10:30 – 11:00 AM

Tea/Coffee/ Refreshments Networking Break & Exhibition

11:00 – 11:30 AM

Signal detection in generic companies with limited PV Resources by Dr. Jurijs Zaičenko, Safety physician, Deputy QPPV in Medical Affairs, JSC Grindeks

11:30  –  12:00 PM

Symogen Speaking Slot

12:00 – 13:00 PM

Panel Discussion : Benefits and Challenges of PV Outsourcing

Moderator: Shelley Gandhi

Panelists: Pippa Biswas, Mircea Ciuca, Gurpreet Singh, Stephanie Jones

13:00 – 14:00 PM

Networking Luncheon

14:00 – 14:30 PM

Bertrand Sailly, Associate Director Safety , Takeda, Switzerland.

14:30 – 15:00 PM

Julia Appelskog, Head of EU QPPV, NOVAVVAX INC, Sweden.

15:00 – 15:30 PM

Afternoon Tea/ Refreshments Networking Break/ Exhibition

15:30 – 16:30 PM

Panel Discussion: Global Harmonization of Pharmacovigilance Regulations: Progress and Roadblocks

Moderator: Shelley Gandhi

Panelists: Pippa Biswas, Mircea Ciuca, Gurpreet Singh, Stephanie Jones

16:30 – 16:45 PM

Closing Remarks & End of Conference

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