PV USA 2025
Day 1 Agenda
8:30 – 9:00 AM
Registrations & Refreshments
9:15 – 9:30 AM
Welcome & Chairperson Opening Remarks
9:30 – 10:00 AM
Keynote Session: 2025 and beyond – Paradigm shift in PV!
Speaker: Khaudeja Bano, Head Global Device Quality, Genentech / Roche | USA.
10:00 – 10:30 AM
10:30 – 11:00 AM
Tea/Coffee/ Refreshments Networking Break & Exhibition
11:00 – 11:30 AM
Platinum Sponsor Presentation by Jaspret Singh, Director of Projects, Innovative Business Unit, PrimeVigilance, USA
11:30 – 12:00 PM
PV Audits in the USA by Heather Murphy, PV Consultant, USA
12:00 – 12:30 PM
PV systems in small / medium sized biotech: Challengers and Potential solutions by Lana Podolski, Head of Global Clinical Safety & Pharmacovigilance,
12:30 – 13:30 PM
Networking Luncheon
13:30 – 14:30 PM
Panel Discussion : Integrating Innovation in Pharmacovigilance Practices
Moderator: Cecily Johnson
Panellists: Industry Leaders and Regulatory Experts
14:30 – 15:00 PM
Safety monitoring in Gene therapy products by Uma Arunagiri, VP, Head Patient Safety & Pharmacovigilance, Spark Therapeutics, Inc. | USA
15:00 – 15:30 PM
Afternoon Tea/ Refreshments Networking Break/ Exhibition
15:30 – 16:30 PM
Round Table Discussions
16:30 – 18:00 PM
Chairperson Closing Remarks & Networking Drinks Reception
Day 2 Agenda
8:30 – 9:15 AM
Registrations & Refreshments
9:15 – 9:30 AM
Welcome & Chairperson Opening Remarks by Stephanie Jane Jones/ Co-Chair Heather Murphy
9:30 – 10:00 AM
The Future of Pharmacovigilance: Harnessing AI and Human Insight for Smarter, Safer Healthcare by Amrit Gill, VP – Global Head of Safety (PV) – GMPV, Opella
10:00 – 10:30 AM
Navigating the Transition: IND Safety Reporting to FAERs by Karthik Muthusamy, Senior Director, Head Expedited Safety Reporting, Bristol Myers Squibb, USA
10:30 – 11:00 AM
Tea/Coffee/ Refreshments Networking Break & Exhibition
11:00 – 11:30 AM
Presentation by Stephanie Jane, Chief Medical Officer, PHARMORA, UK
11:30 – 12:00 PM
Presentation by Nicole Baker, CEO, Biologit | Ireland
12:00 – 12:30 PM
Patient Advocacy and the Future of Pharmacovigilance: Empowering Patients as Partners in Drug Safety by Layo Immanuel, Global Patient Safety Physician, Takeda | USA
12:30 – 13:30 PM
Networking Luncheon
13:30 – 14:30 PM
Panel Discussion : The Role of Real-World Evidence in Regulatory Decision Making
Moderator: Heather Murphy
Panellists: Regulatory Officials & Industry Leaders
14:30 – 15:00 PM
Future Trends in Regulatory Affairs
15:00 – 15:30 PM
Afternoon Tea/ Refreshments Networking Break/ Exhibition
15:30 – 16:30 PM
Round Table Discussion
16:30 – 17:00 PM
Chairperson Closing Remarks, Conference Wrap-Up and Future Directions
Trusted hands behind us
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Our global upcoming event in Pharmacovigilance has a great line up of Industry speakers and Hot Off the press topics. After witnessing outstanding success in our previous PV conferences, we are delighted to host PV Europe 2022. Click “DOWNLOAD BROCHURE” to download the agenda!
International Delegate Registrations From Across The Globe
