38th Pharmacovigilance USA 2025
38th PHARMACOVIGILANCE USA 2025
7th & 8th May , 2025
The Inn at Longwood Medical, Boston
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5 Reasons
to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminate travel hassles & access quality content at your own pace.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Event Speakers
Khaudeja B
Roche – Genentech
Mariette B treefland
HSI
Milind S
Novo Nordisk
Nina Kola
Bristol Myers Squibb
Vishnuvardhan R P
Sumitomo Pharma
Danytza W
Jazz Pharmaceuticals
E. Alton Sartor
AstraZeneca
Jessica C J
Jazz Pharmaceuticals
Dr. Karthik M
Bristol-Myers Squibb
William Blumentals
Sanofi
Sharon M R
Pfizer, Inc.
Kshitija B
Jazz Pharmaceuticals
Vikalp Khare
Otsuka Pharmaceutical
Ram Vempati
BioNTech SE
Beena Wood
CSL Behring
Matt D
CSL Behring
Namita J
Sanofi
Reem Yasin
Kawkab group
Abbey Gow
Sanofi
Mandy Gervasio
Comanche Biopharma
Nicole B
Biologit
Yilong Jia
Sumitomo Pharma
Ashish J
Curis
Meera Nagaria
Johnson & Johnson
Kapil B
Asklepios
Siva K B
Indegene
Anka G. Ehrhardt
Merck
Jason Bryant
ArisGlobal
Karthik Babu
Sanofi
Heather M
HMGlobal
Heather L F
AI MINDSystems Foundation
Ben Locwin
Black Diamond Networks
Ankit Lodaya
Bluebird Bio
Event Schedule
Meet to learn and network with your conference colleagues.
08:50 - Chairperson opening remarks
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
09:00 – Pharmacovigilance Quality Assurance (QA)/Quality Control (QC) Synergy Identification and Simplification
Abbey Gow
QA & Deviation Management Expert,
Sanofi
09:30 – PV Ecosystem is continuously evolving- Combination Products and now Diagnostics and Digital
Combination Products
- How do we as an industry partner with the Regulatory bodies and agencies to share our voice
- People / Processes and Technology – as enablers to maintain the patient-centric approach
- How do we truly ensure that safety is our priority – regardless of its source – Drug, Device, Diagnostic or Digital therapeutics
Speaker
Khaudeja Bano
VP – Global Head of Device Quality,
Roche – Genentech
10:00 – Keynote Panel Discussion: Next generation pharmacovigilance for enhanced patient safety
Patient Safety
- Driving patient centricity into your PV plans
- Patient Support Program in Pharmacovigilance
- A review of general issues and the specific challenges with patients
- Improving your organization’s patient-facing communications and its importance
- A practical approach to reshaping patient safety
- Educating stakeholders via patient stories
Moderator
Mariette B S
SVP, Worldwide Patient Safety Officer
Bristol-Myers Squibb
Panellists
Khaudeja Bano
VP – Global Head of Device Quality,
Roche – Genentech
Namita Joshi
Regional PV Head,
Sanofi, North America
Karthik M
Head of Expedited Safety Reporting,
Bristol-Myers Squibb
Karthik B
CHC Global PV Operations Head,
Sanofi
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Topic TBC
Speaker TBC,
Cencora
11:40 - Pharmacovigilance Compliance for future – Moving forward positively
Compliance
- Future horizons and efficiencies in PV Compliance
- Managing quality risks
- Fostering culture of inspection readiness preparing for, inspections
- Future-proofing organizations
- Boldly Shaping the Future
Jessica C J
Exec Dir, Regulatory and PV Compliance,
Jazz Pharmaceuticals
Kshitija Bapat
Dir, Compliance Operations,
Jazz Pharmaceuticals
12:10 – Harnessing GenAI to Advance Pharmacovigilance
- Explore the expansive potential of GenAI in transforming pharmacovigilance, including ArisGlobal’s approach to future capabilities and uncertainty.
- Discover the in-market extraction and generation capabilities of LifeSphere NavaX and learn how these capabilities are being developed to enhance performance.
- Learn about ArisGlobal’s commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.
- Learn about ArisGlobal’s commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.
Speaker
Jason Bryant
VP Data & AI,
ArisGlobal
12:40 – Networking luncheon
13:30 – Panel Discussion - Technology: Unlocking the better ways in PV for safer drugs
Impact of Technology
- Acceleration of Digitalisation in Pharma is the key to innovation in Pharmacovigilance
- How long can AI, process automation and improvements give a hand in PV?
- ML in patient monitoring: How do industrial experts see this?
- Regulatory decision – Making: In what way AI makes the path easier?
- Modern technologies in pharmacovigilance – The way forward
- Signal detection and safety data analysis
- Implementation Challenges – Preparing for a smooth transition
- Pitfall and Learnings
Moderator
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
Panellists
E Alton Sartor
Medical Director, Patient Safety Physician Digital & Devices,
AstraZeneca
Beena Wood
Head of Innovation & Technology,
CSL Behring
Ram Vempati
Senior Safety Physician,
BioNTech SE
Matt D
Head, Global Safety Sciences,
CSL Behring
Yilong Jia
Sr. Manager Pharmacovigilance Informatics,
Sumitomo Pharma America
14:20 – Topic TBC
Speaker TBC,
Veeva Systems
14:50 – Pharmacovigilance’s Exponential Technology Upgrade: the Emerging Role of the Patient, their Personal AI Agents, and their Personal Digital Twins
AI & Patients
- How do we as an industry partner with the Regulatory bodies and agencies to share our voice
- PV and beyond: newly-empowered patients’ relationships to next-generation, pre-competitive industry utilities for pan-stakeholder, privacy-preserving, decentralized data and AI
- Verifications, attestations, and audits on-demand: multi-directional, cryptographically-provable reporting and communications from multiple provider institutions and patients directly
- From clinical trials to post-market surveillance to label expansion: accelerating the flywheel of increasing both safety and precision through in silico research and simulations
Speaker
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
15:20 - Afternoon Networking Coffee/Tea & Discussion
15:40 – AI in Pharmacovigilance: Streamlining Local and Global Literature Surveillance
- The challenges of Local Literature in Pharmacovigilance
- How AI is Transforming Literature Surveillance
- Regulatory Considerations and AI Adoption
- Regulatory Considerations and AI Adoption
Speaker
Nicole Baker
CEO,
Biologit
16:00 – Panel Discussion: Navigating the challenges with a global PV
Challenges & Opportunities
- What comes next for the industry?
- Challenges of Global PV function in a changing business environment
- Automating pharmacovigilance: Are we ready for the up coming future?
- How global PV impacts day to day operations?
- Proper communication between – Sponsor – Site – CRO – Patients
- Moving towards a better future: bigger and better
- Best practices & lessons learnt today
Moderator
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
Panellists
Nina Kolar
Head Medical Safety Assessment Hematology and Oncology,
Bristol-Myers Squibb
Milind S
Senior Director, Safety Surveillance,
Global Patient Safety, Novo Nordisk
Kshitija Bapat
Dir, Compliance Operations,
Jazz Pharmaceuticals
Mandy Gervasio
Vice President QA & Compliance,
Comanche Biopharma
Vikalp Khare
Director,
Otsuka Pharmaceutical
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – 18:15 – Networking Drinks
08:50 - Chairperson opening remarks
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
09:00 – Pharmacovigilance Quality Assurance (QA)/Quality Control (QC) Synergy Identification and Simplification
Abbey Gow
QA & Deviation Management Expert,
Sanofi
09:30 – PV Ecosystem is continuously evolving- Combination Products and now Diagnostics and Digital
Combination Products
- How do we as an industry partner with the Regulatory bodies and agencies to share our voice
- People / Processes and Technology – as enablers to maintain the patient-centric approach
- How do we truly ensure that safety is our priority – regardless of its source – Drug, Device, Diagnostic or Digital therapeutics
Speaker
Khaudeja Bano
VP – Global Head of Device Quality,
Roche – Genentech
10:00 – Keynote Panel Discussion: Next generation pharmacovigilance for enhanced patient safety
Patient Safety
- Driving patient centricity into your PV plans
- Patient Support Program in Pharmacovigilance
- A review of general issues and the specific challenges with patients
- Improving your organization’s patient-facing communications and its importance
- A practical approach to reshaping patient safety
- Educating stakeholders via patient stories
Moderator
Mariette B S
SVP, Worldwide Patient Safety Officer
Bristol-Myers Squibb
Panellists
Khaudeja Bano
VP – Global Head of Device Quality,
Roche – Genentech
Namita Joshi
Regional PV Head,
Sanofi, North America
Karthik M
Head of Expedited Safety Reporting,
Bristol-Myers Squibb
Karthik B
CHC Global PV Operations Head,
Sanofi
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Topic TBC
Speaker TBC,
Cencora
11:40 - Pharmacovigilance Compliance for future – Moving forward positively
Compliance
- Future horizons and efficiencies in PV Compliance
- Managing quality risks
- Fostering culture of inspection readiness preparing for, inspections
- Future-proofing organizations
- Boldly Shaping the Future
Jessica C J
Exec Dir, Regulatory and PV Compliance,
Jazz Pharmaceuticals
Kshitija Bapat
Dir, Compliance Operations,
Jazz Pharmaceuticals
12:10 – Harnessing GenAI to Advance Pharmacovigilance
- Explore the expansive potential of GenAI in transforming pharmacovigilance, including ArisGlobal’s approach to future capabilities and uncertainty.
- Discover the in-market extraction and generation capabilities of LifeSphere NavaX and learn how these capabilities are being developed to enhance performance.
- Learn about ArisGlobal’s commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.
- Learn about ArisGlobal’s commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.
Speaker
Jason Bryant
VP Data & AI,
ArisGlobal
12:40 – Networking luncheon
13:30 – Panel Discussion - Technology: Unlocking the better ways in PV for safer drugs
Impact of Technology
- Acceleration of Digitalisation in Pharma is the key to innovation in Pharmacovigilance
- How long can AI, process automation and improvements give a hand in PV?
- ML in patient monitoring: How do industrial experts see this?
- Regulatory decision – Making: In what way AI makes the path easier?
- Modern technologies in pharmacovigilance – The way foward
- Signal detection and safety data analysis
- Implementation Challenges – Preparing for a smooth transition
- Pitfall and Learnings
Moderator
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
Panellists
E Alton Sartor
Medical Director, Patient Safety Physician Digital & Devices,
AstraZeneca
Beena Wood
Head of Innovation & Technology,
CSL Behring
Ram Vempati
Senior Safety Physician,
BioNTech SE
Matt D
Head, Global Safety Sciences,
CSL Behring
Yilong Jia
Sr. Manager Pharmacovigilance Informatics,
Sumitomo Pharma America
14:20 – Topic TBC
Speaker TBC,
Veeva Systems
14:50 – Pharmacovigilance’s Exponential Technology Upgrade: the Emerging Role of the Patient, their Personal AI Agents, and their Personal Digital Twins
AI & Patients
- How do we as an industry partner with the Regulatory bodies and agencies to share our voice
- PV and beyond: newly-empowered patients’ relationships to next-generation, pre-competitive industry utilities for pan-stakeholder, privacy-preserving, decentralized data and AI
- Verifications, attestations, and audits on-demand: multi-directional, cryptographically-provable reporting and communications from multiple provider institutions and patients directly
- From clinical trials to post-market surveillance to label expansion: accelerating the flywheel of increasing both safety and precision through in silico research and simulations
Speaker
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
15:20 - Afternoon Networking Coffee/Tea & Discussion
15:40 – AI in Pharmacovigilance: Streamlining Local and Global Literature Surveillance
- The challenges of Local Literature in Pharmacovigilance
- How AI is Transforming Literature Surveillance
- Regulatory Considerations and AI Adoption
- Regulatory Considerations and AI Adoption
Speaker
Nicole Baker
CEO,
Biologit
16:00 – Panel Discussion: Navigating the challenges with a global PV
Challenges & Opportunities
What comes next for the industry?
Challenges of Global PV function in a changing business environment
Automating pharmacovigilance: Are we ready for the up coming future?
How global PV impacts day to day operations?
Proper communication between – Sponsor – Site – CRO – Patients
Moving towards a better future: bigger and better
Best practices & lessons learnt today
Moderator
Heather L F
CEO & Co-Founder,
AI MINDSystems Foundation
Panellists
Nina Kolar
Head Medical Safety Assessment Hematology and Oncology,
Bristol-Myers Squibb
Milind S
Senior Director, Safety Surveillance,
Global Patient Safety, Novo Nordisk
Kshitija Bapat
Dir, Compliance Operations,
Jazz Pharmaceuticals
Mandy Gervasio
Vice President QA & Compliance,
Comanche Biopharma
Vikalp Khare
Director,
Otsuka Pharmaceutical
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – 18:15 – Networking Drinks
09:00 - Chairperson opening remarks
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
09:10 – Behind Every Successful Drug also Stands an Excellent CMC
PV & CMC
Speaker
Anka Ehrhardt
Director, Cell-Based Assays,
Analytical Research & Development, Merck
09:40 – Managing Pharmacovigilance Audits & Inspections
Audits & Inspection
- Staying ahead in the race – Current trends for and future guidelines
- How to prepare and what to expect?
- Remote audits and inspections – Logistical issues
- PV Inspection readiness: Keeping on the right side of inspectors
- Methodologies, scope and oversight
- Boldly shaping the future
- What has this pandemic thought us towards audits and inspections?
Speaker
Kapil Bhutada
Head of PV Safety Operation & Compliance,
Asklepios BioPharmaceutical
10:10 – Topic TBC
Speaker TBC
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Real World Data to Real World Evidence
RWD/RWE
- Importance of real-world data for answering regulatory questions
- Benefits and challenges of evidence derived from real world sources
- Real World Evidence: How Does its Use challenge quality and compliance programs?
- Obtaining patient-centric using RWE
- What are complications that will rise by inserting new data source? Breakup in data?
- Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
Speaker
William A Blumental
Head of Pharmacoepidemiology,
Specialty Care, Sanofi
11:40 – How to build and present a Data Story with then Analytical Ask hierarchy: NLP based PV perspective
Meera Nagaria
Senior Data Scientist,
Johnson & Johnson
12:10 – PV Audits in the USA
- The need for PV audits
- Types of PV audits
- Overview of thePV audit process
- Audit Challenges/Opportunities
- Common PV Audit Findings
Speaker
Heather Murphy
Founder and CEO,
HMGlobal Pharmacovigilance Consulting
12:30 – Networking luncheon
13:30 – Panel Discussion - The “Next Generation” risk man agement strategies
Risk Management & Planning
Implementation and maintenance of RMP’s – Overcoming its challenges
Potential analyzing of safety and risk signals in PV
Strategies to minimize the risk measures – what are the new developments?
Benefit/Risk ratio: the common Denominator FDA REMA Logic Model
Risk Evaluation and Mitigation Strategies (REMS) – new challenges and chances
Stakeholders in REMS – Communications must be improved
Implementing a Risk-Based Monitoring Solution: Understanding the basics of a ssustainable model
Discussing about the strategies that support the PV from beginning to end
Moderator
Danytza Ward
Executive Director, Head of PV Operations & Global Risk Management,
Jazz Pharmaceuticals
Panellists
Vishnuvardhan Reddy Peddagalli
Global Head of PV & Risk Management,
Sumitomo Pharma
Sharon Reid
Director of Risk Management Center of Excellence,
Pfizer
Siva Kumar Buddha
Director – PV (Head of Signal & Risk Management),
ndegene
Reem Yasin
Quality Assurance & PV Manager,
Kawkab group (Iraq)
14:20 – Panel Discussion: Key regulatory updates that can impact the PV to increase patient’s safety
Regulatory Update
Current and future trends in PV regulations – A Step forward
Balancing the critical elements of speed and safety
Guidelines for critical medicines
Future Legislation: PV Industry Vision
Enhancing communication between regulators, regional authorities and patients
Examine the global regulatory landscape for safety evaluation – Lessons to learn
What’s next? Ways to proceed forward.
Moderator
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
Panellists
Jessica Chinault-Jalboot
Exec Director, Regulatory and PV Compliance,
Jazz Pharmaceuticals
Ashish Jain
Sr, Director,
Clinical Safety & Pharmacovigilance, Curis
Ankit Lodaya
Sr. Director, Pharmacovigilance,
Bluebird Bio
15:00 - Afternoon Networking Tea/Coffee & End of conference
09:00 - Chairperson opening remarks
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
09:10 – Behind Every Successful Drug also Stands an Excellent CMC
PV & CMC
Speaker
Anka Ehrhardt
Director, Cell-Based Assays,
Analytical Research & Development, Merck
09:40 – Managing Pharmacovigilance Audits & Inspections
Audits & Inspection
- Staying ahead in the race – Current trends for and future guidelines
- How to prepare and what to expect?
- Remote audits and inspections – Logistical issues
- PV Inspection readiness: Keeping on the right side of inspectors
- Methodologies, scope and oversight
- Boldly shaping the future
- What has this pandemic thought us towards audits and inspections?
Speaker
Kapil Bhutada
Head of PV Safety Operation & Compliance,
Asklepios BioPharmaceutical
10:10 – Topic TBC
Speaker TBC
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Real World Data to Real World Evidence
RWD/RWE
- Importance of real-world data for answering regulatory questions
- Benefits and challenges of evidence derived from real world sources
- Real World Evidence: How Does its Use challenge quality and compliance programs?
- Obtaining patient-centric using RWE
- What are complications that will rise by inserting new data source? Breakup in data?
- Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
Speaker
William A Blumental
Head of Pharmacoepidemiology,
Specialty Care, Sanofi
11:40 – How to build and present a Data Story with then Analytical Ask hierarchy: NLP based PV perspective
Meera Nagaria
Senior Data Scientist,
Johnson & Johnson
12:10 – PV Audits in the USA
- The need for PV audits
- Types of PV audits
- Overview of thePV audit process
- Audit Challenges/Opportunities
- Common PV Audit Findings
Speaker
Heather Murphy
Founder and CEO,
HMGlobal Pharmacovigilance Consulting
12:30 – Networking luncheon
13:30 – Panel Discussion - The “Next Generation” risk man agement strategies
Risk Management & Planning
Implementation and maintenance of RMP’s – Overcoming its challenges
Potential analyzing of safety and risk signals in PV
Strategies to minimize the risk measures – what are the new developments?
Benefit/Risk ratio: the common Denominator FDA REMA Logic Model
Risk Evaluation and Mitigation Strategies (REMS) – new challenges and chances
Stakeholders in REMS – Communications must be improved
Implementing a Risk-Based Monitoring Solution: Understanding the basics of a ssustainable model
Discussing about the strategies that support the PV from beginning to end
Moderator
Danytza Ward
Executive Director, Head of PV Operations & Global Risk Management,
Jazz Pharmaceuticals
Panellists
Vishnuvardhan Reddy Peddagalli
Global Head of PV & Risk Management,
Sumitomo Pharma
Sharon Reid
Director of Risk Management Center of Excellence,
Pfizer
Siva Kumar Buddha
Director – PV (Head of Signal & Risk Management),
ndegene
Reem Yasin
Quality Assurance & PV Manager,
Kawkab group (Iraq)
14:20 – Panel Discussion: Key regulatory updates that can impact the PV to increase patient’s safety
Regulatory Update
Current and future trends in PV regulations – A Step forward
Balancing the critical elements of speed and safety
Guidelines for critical medicines
Future Legislation: PV Industry Vision
Enhancing communication between regulators, regional authorities and patients
Examine the global regulatory landscape for safety evaluation – Lessons to learn
What’s next? Ways to proceed forward.
Moderator
Ben Locwin
VP, Project Solutions,
Black Diamond Networks
Panellists
Jessica Chinault-Jalboot
Exec Director, Regulatory and PV Compliance,
Jazz Pharmaceuticals
Ashish Jain
Sr, Director,
Clinical Safety & Pharmacovigilance, Curis
Ankit Lodaya
Sr. Director, Pharmacovigilance,
Bluebird Bio
15:00 - Afternoon Networking Tea/Coffee & End of conference
Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
The Inn at
Longwood Medical
342 Longwood Ave, Boston
MA 02115,
United States
+1 617-731-4700
Venue The Inn at Longwood Medical
342 Longwood Ave, Boston
MA 02115,
United States
+1 617-731-4700
