8:30   –  8:45 AM

Registrations & Refreshments

8:45   –  9:00 AM

Welcome & Chairperson Opening Remarks

9:00   –  09:30 AM

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

09:30 – 10:00 AM

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

10:00 – 10:30 AM

Integrated Risk Management: RM Strategy Planning, Implementation, Evaluation by Michael Von Forstner, Head of Global Safety Science, Sobi, Switzerland

10:30 – 11:00 AM

Tea/Coffee/ Refreshments Networking Break & Exhibition

11:00  –  11:30 AM

Platinum Speaking Sponsor Slot (TBC)

11:30  –  12:00 PM

Patient Engagement/Centricity in PV by Yvonne Naincu, Country Head, Bayer

12:00  –  12:30 PM

Gold Sponsor Speaking Slot (TBC)

12:30  – 13:00 PM

13:00  – 14:00 PM

PV Audits in the USA (Challenges, Opportunities & Audits unique to the USA (e.g. REMS)) by Heather Murphy, Founder and CEO HMGlobal Pharmacovigilance Consulting, LLC

Networking Luncheon

14:00 – 15:00 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

15:00 – 15:30 PM

Medicines and Healthcare products Regulatory Agency (MHRA) Speaking Slot

15:30 – 16:00 PM

Afternoon Tea/ Refreshments Networking Break/ Exhibition

16:00 – 16:30 PM

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

16:30 – 17:30 PM

ROUND TABLE DISCUSSIONS 

17:30 – 18:30 PM

Chairperson Closing Remarks & Networking Drinks Reception