08th May 38th Pharmacovigilance USA 2025 – Day 2

09:00 - Chairperson opening remarks

BEN LOCWIN, VP, Project Solutions, Black Diamond Networks

08th May 38th Pharmacovigilance USA 2025 – Day 2

PV & CMC

09:10 – Behind Every Successful Drug also Stands an Excellent CMC

ANKA EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck

08th May 38th Pharmacovigilance USA 2025 – Day 2

AI & PATIENTS

09:40 – Pharmacovigilance’s Exponential Technology Upgrade: the Emerging Role of the Patient, their Personal AI Agents, and their Personal Digital Twins

•   Personal data estates, personal AI agents, and personal digital twins: understanding the fast-approaching, radically-enhanced role of the patient in PV
•   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

HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation

08th May 38th Pharmacovigilance USA 2025 – Day 2

RWD / RWE

11:10 – Real World Data to Real World Evidence

•   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.

WILLIAM A. BLUMENTALS, Head of Pharmacoepidemiology, Specialty Care, Sanofi

08th May 38th Pharmacovigilance USA 2025 – Day 2

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

08th May 38th Pharmacovigilance USA 2025 – Day 2

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

HEATHER MURPHY, Founder and CEO, HMGlobal Pharmacovigilance Consulting

08th May 38th Pharmacovigilance USA 2025 – Day 2

12:30 – Networking luncheon

08th May 38th Pharmacovigilance USA 2025 – Day 2

RISK MANAGEMENT & PLANNING

13:30 – Panel Discussion - The “Next Generation” risk man agement strategies

•   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
CARMIT STRAUSS, Executive Director, Head of Risk Management and Organ Toxicity, Takeda Pharmaceuticals
SHARON REID, Director of Risk Management Center of Excellence, Pfizer
SIVA KUMAR BUDDHA, Director - PV (Head of Signal & Risk Management), Indegene
REEM YASIN, Quality Assurance & PV Manager, Kawkab group (Iraq)

08th May 38th Pharmacovigilance USA 2025 – Day 2

REGULATORY UPDATE

14:20 – Panel Discussion: Key regulatory updates that can impact the PV to increase patient’s safety

•   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 Dir, Regulatory and PV Compliance, Jazz Pharmaceuticals
ASHISH JAIN, Sr, Director, Clinical Safety & Pharmacovigilance, Curis

08th May 38th Pharmacovigilance USA 2025 – Day 2

15:00 - Afternoon Networking Tea/Coffee & End of conference

07th May 38th Pharmacovigilance USA 2025 – Day 1

08:50 - Chairperson opening remarks

BEN LOCWIN, VP, Project Solutions, Black Diamond Networks

07th May 38th Pharmacovigilance USA 2025 – Day 1

09:00 – Pharmacovigilance Quality Assurance (QA)/Quality Control (QC) Synergy Identification and Simplification

ABBEY GOW, QA & Deviation Management Expert, Sanofi

07th May 38th Pharmacovigilance USA 2025 – Day 1

COMBINATION PRODUCTS

09:30 – PV Ecosystem is continuously evolving- Combination Products and now Diagnostics and Digital

•   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

KHAUDEJA BANO, VP - Global Head of Device Quality, Roche - Genentech

07th May 38th Pharmacovigilance USA 2025 – Day 1

PATIENT SAFETY

10:00 – Keynote Panel Discussion: Next generation pharmacovigilance for enhanced 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 BOERSTOEL-STREEFLAND, SVP, Worldwide Patient Safety Officer, Bristol-Myers Squibb

Panellists
KHAUDEJA BANO, VP - Global Head of Device Quality, Roche – Genentech
KARTHIK MUTHUSAMI, Head of Expedited Safety Reporting, Bristol-Myers Squibb
KARTHIK BABU, CHC Global PV Operations Head, Sanofi

07th May 38th Pharmacovigilance USA 2025 – Day 1

10:40 – Morning Networking Coffee/Tea & Discussion

07th May 38th Pharmacovigilance USA 2025 – Day 1

COMPLIANCE

11:40 - Pharmacovigilance Compliance for future – Moving forward positively

•   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 CHINAULT-JALBOOT, Exec Dir, Regulatory and PV Compliance, Jazz Pharmaceuticals
KSHITIJA BAPAT, Dir, Compliance Operations, Jazz Pharmaceuticals

07th May 38th Pharmacovigilance USA 2025 – Day 1

12:10 – Topic TBC

JASON BRYANT, VP Data & AI, ArisGlobal

07th May 38th Pharmacovigilance USA 2025 – Day 1

12:40 – Networking luncheon

07th May 38th Pharmacovigilance USA 2025 – Day 1

IMPACT OF TECHNOLOGY

13:30 – Panel Discussion - Technology: Unlocking the better ways in PV for safer drugs

•   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
•   Implementation Challenges - Preparing for a smooth transition
•   Pitfall and Learnings

Moderator
HEATHER LEIGH FLANNERY, 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, Medical Director, BioNTech SE

07th May 38th Pharmacovigilance USA 2025 – Day 1

14:20 – Topic TBC

Speaker TBC, Veeva Systems

07th May 38th Pharmacovigilance USA 2025 – Day 1

AUDITS & INSPECTIONS

14:50 – Managing Pharmacovigilance Audits & Inspections

•   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?

KAPIL BHUTADA, Head of PV Safety Operation & Compliance, Asklepios BioPharmaceutical

07th May 38th Pharmacovigilance USA 2025 – Day 1

15:20 - Afternoon Networking Coffee/Tea & Discussion

07th May 38th Pharmacovigilance USA 2025 – Day 1

QUALITY - SAFETY – SIGNAL DETECTION

15:40 - Quality, Safety Evaluation & Signal Detection – Important Considerations - Analise to Adapt

•   Developing a global safety intelligence process
•   Exploring patient support and marketing research programs from a safety perspective
•   Develop an aggregate safety assessment planning (ASAP) process – Its importance
•   Expectations for quality and compliance in pharmacovigilance process and systems
•   What is now essential for both good quality management and to drive continuous improvement?
•   Statistical signal detection as a routine pharmacovigilance practice

07th May 38th Pharmacovigilance USA 2025 – Day 1

CHALLENGES & OPPORTUNITIES

16:10 – Panel Discussion: Navigating the challenges with a global PV

•   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
ANKA EHRHARDT, Director, Cell-Based Assays / Analytical Research &, Development, Merck

Panellists
MILIND SARDESA, Senior Director, Safety Surveillance, Global Patient Safety, Novo Nordisk
NINA KOLA, VP, Head Medical Safety Assessment Hematology and Oncology, Bristol-Myers Squibb
KSHITIJA BAPAT, Director, Compliance Operations, Jazz Pharmaceuticals
VIKALP KHARE, Director, Otsuka Pharmaceutical

07th May 38th Pharmacovigilance USA 2025 – Day 1

17:00 – Closing remarks by chairperson and End of day 01 conference

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

08:30 – Coffee and registration

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

09:00 – Morning Chair’s opening remarks

NIGEL CRYER, Managing Director, Bluciela-Lifesciences (Former Deputy Director Global Audit, Sanofi Pasteur)

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

09:10 – Enhancing Drug Distribution Security: Why Standards Matter

• Security and interoperability through technology standards
• Implementing industry-driven standards
• Learnings from the US pharmaceutical ecosystem

CHRISTIANE WIRRIG, Customer Success Manager, Spherity, (Co-Chair Policy, OCI)

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

09:40 – Relevance and Power of the Business Case

•   The Business Case Blueprint: Impactful, Convincing and Comprehensive
•   From Idea to Impact: Unlocking the True Power of a Business Case
•   Mastering the Art of Persuasion: Building a Business Case That Delivers
•   Anti-Counterfeiting and Beyond: Is There a Business Case Worth Pursuing?

HEIKO TREFZGER, Product Manager Data & Insights, Roche

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

SERIALIZATION, TRACK & TRACE

10:10 – Panel Discussion with experts - Challenges and Solutions in Pharma Serialisation and Track & Trace

•   Counterfeit Protection with Serialization and Track & Trace
•   How can a global serialization project be successfully and efficiently implemented?
•   Uncover strategies for implementing a dependable, secure serialisation improvement plan.
•   Unlocking Efficiency - How Digital Transformation and Serialisation Drive Global Effectiveness in Pharma Manufacturing
•   What are the current requirements to follow in serialisation? How to ensure that you are up to date with all global traceability regulations?
•   How can the Track & Trace process be optimized?
•   How can long-term successful serialisation strategies be created?
•   Practical approach to implementing a serialisation solution – Challenges and Solutions

Moderator
NIGEL CRYER, Managing Director, Bluciela-Lifesciences (Former Deputy Director Global Audit, Sanofi Pasteur)

Panellists
LORRAINE GUILDEA, Associate Director Supply Chain – Serialisation, Jazz Pharmaceuticals
ROSALINDA DEVOS, Director, Digital Identification & Traceability, Johnson & Johnson
MARTINA LUPANO, IT Product Manager -Global Manufacturing Execution System, Roche
AMIT DESHPANDE, Serialization, Product Track & Trace Lead, Sandoz
VLADIMIR SAPUNDZHIEV, Software Architect for Track & Trace Solutions, Sopharma
CHRISTIANE WIRRIG, Customer Success Manager, Spherity (Co-Chair Policy, OCI)

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

11:00 – Morning Coffee & Networking

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

INTERPOL FIGHTS PHARMA CRIME

11:30 - INTERPOL’s mandate in fighting against pharmaceutical crime

•   What is the role of INTERPOL in this crime area ?
•   How INTERPOL interacts with other entities to tackle pharma crime ?
•   What are the relevant results ?
•   Focus on ops PANGEA
•   What are the challenges ?
•   What are the prospects for INTERPOL ?

MOUSSA THIOMBIANO, Criminal Intelligence Officer, Public Health and Pharmaceutical Crime Unit, IGGH Programme, INTERPOL

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

12:10 – Strategic Timing for Implementation of GS1 Standards in Chinese Pharmaceutical Market

•   Overview of the Chinese Pharmaceutical Market
•   Why GS1 Standards Are Essential in Pharmaceuticals in China (Serialization, Traceability and Compliance with Regulations)
•   Strategic Timing for Implementation
•   Challenges in the Chinese Pharmaceutical Market
•   Long-term Benefits of GS1 Standards in China
•   Customer Cases for GS1 Usage in the Chinese Market
•   Call to action: Pharmaceuticals need to start the implementation process now to stay ahead in the evolving market

META HE, Global Business Manager Track & Trace, Beijing Acctrue Technology

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

12:30 – Networking luncheon / Exhibition Visit

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

13:20 – From production to patient – Improving the efficiency of the healthcare value chain

•   Bridging Silos and Fostering Collaboration
•   Digital Transformation and Technology Integration
•   Providing better predictability and visibility
•   Embedding Sustainability into the Healthcare Value Chain

MONIKA DERECQUE-POIS, Founding Member, HCI - Healthcare Chain Institute

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

SCM – AI & AUTOMATION

14:20 – Navigating Pharma Supply Chain Transformation through AI & Automation

•   Harnessing AI for End-to-End Supply Chain Visibility: How AI and advanced analytics enhance transparency from manufacturing to last-mile delivery, improving risk management and data-driven decision-making.
•   Scalability of Automation in Complex Supply Chains: integration of AI Co-Pilots in accelerating automation implementations to streamline processes, reduce manual intervention, and improve service levels across the pharmaceutical supply chain.
•   1-2 Real-world Use Cases: practical examples showcasing how AI and automation have transformed supply chain operations, including demand forecasting, and reducing lead-time volatility through process mining.

MIRIAM HAAF, Member of the Board of Advisors, Pharma Now

20th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 2

14:50 – 15:00 – Chairperson’s closing remarks / Evening networking Coffee / Tea

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

08:30 – Coffee and registration

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

09:00 – Morning Chair’s opening remarks

NIGEL CRYER, Managing Director, Bluciela-Lifesciences (Former Deputy Director Global Audit, Sanofi Pasteur)

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

SERIALISATION – TRACK & TRACE

09:10 – Is the QR Code the Death of the GS1 DataMatrix Code? – 2025 Edition

•   Ways to access electronic Product Information (ePI) via barcode scanning
•   Can Apple and Google help?
•   How can batch-specific ePI be managed?
•   Making ePI a reality: What’s next?

STEFAN ARTLICH, Director & Global Process Owner ‘Track&Trace’, Bayer

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

SUPPLY CHAIN

09:50 – Supply Chain: Drive Business Results from Strategy to Execution

•   Supply Chain as CEO’s co-pilot
•   Driving Growth, Profitability, and Capital Efficiency
•   Making supply chains more resilient
•   Adapting to changes in demand patterns, business environment
•   Digital Supply Chain beyond buzzwords

VINEET KHANNA, Former Senior VP, Global Head of Supply Chain, Nestle

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

10:50 – Morning Coffee & Networking

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

11:20 – Keynote Panel Discussion: Building a reliable and sustainable supply chain to fight the fake

•   Securing the future – The new way forward for Pharma Supply Chain
•   Optimizing your pharma supply chain for sustainability
•   Ways to make your supply chain more resilient
•   Establishing good partnerships with key suppliers
•   Plan for potential disruptions and have exit plans
•   What governments can do to support resilience in the Pharma supply chain
•   Overcoming supply chain challenges and actionable steps to increase efficiency

Moderator
NIGEL CRYER, Managing Director, Bluciela-Lifesciences (Former Deputy Director Global Audit, Sanofi Pasteur)

Panellists
VINEET KHANNA, Former Senior VP, Global Head of Supply Chain, Nestle
MONIKA DERECQUE-POIS, Founding Member, HCI - Healthcare Chain Institute
MUELLER CHRISTIAN, Global Serialization Expert, Roche
OLUSEGUN ADETUNJI, Global External Manufacturing & Supplier Stream Lead, Sanofi
NADINE LAMPKA, Senior Product Manager Pharma-Security, Schreiner Group

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

12:40 – Networking luncheon / Exhibition Visit

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

FIGHTING FAKES – BRAND PROTECTION

13:40 – Fight the FAKE – Protect the public

•   Worldwide illicit trade – a growing concern
•   The growing online threats – are we underestimating?
•   Building effective brand protection strategies
•   Leveraging partnerships & raising awareness – a force multiplier
•   Online to offline case study
•   Challenges and future prospects

KAREN LEYSEN, Director, Global Brand Protection, Europe, Middle East & Africa (EMEA), Johnson & Johnson
DIRENC BADA, Managing Associate, Gun + Partners

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

15:20 – Afternoon coffee & Networking

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

SCM

15:40 – Unlock the Power of Large Language Models

Join us for an insightful talk on the value of LLMs for big companies. Learn how to build a roadmap for successful implementation and overcome hurdles associated with this transformative technology. Gain practical lessons from real-world examples, empowering you to maximize the potential of LLMs and drive success in your organization.
•   Use cases for LLMs in supply chain management
•   Hurdles and lessons learned of building a use case road map for LLMs
•   Change management activities to encourage and enable your organization

FRANK GIROUX, Digital SCM Transformation Manager, Bayer

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

16:10 – Mobile Analytical Anticounterfeiting Drug Screening Device for Patient Safety

GREGOIRE SAGET, Product Conformity Specialist, Spectral Engines

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

REGULATORY

16:30 – How can products be delivered on time and in full compliance with regulatory requirements under time pressure?

•   “Challenges and Opportunities: Navigating the Regulatory Landscape”
•   “Strategies for Successful Implementation: Overcoming Regulatory Hurdles”

KWEE LAN TAN, Regional Regulatory Lead, Emerging Markets, Boehringer Ingelheim

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

17:00 – Chairperson’s closing remarks and end of conference

19th February 15th Annual Pharma Serialisation & Supply Chain 2025 – Day 1

17:10 – 18:30 – Networking Drinks Session

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

08:00 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

08:50 – Chairperson opening remarks

PAV RISHIRAJ, Director, Head of Pharmacovigilance, Ipsen

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

AUDITS & INSPECTIONS

09:00 – Unveiling the good, the bad, and the data-ful (GVP inspections)

•   Why are inspections important and necessary?
•   What types of inspections are out there? Potential challenges?
•   What is the process? – what to expect? How ready can we be? Results?
•   What do the CAs say?
•   Lessons learnt

ERIKA BARBAROSIE, Associate Director of Compliance

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

09:30 - Optimizing use of RWD/RWE for pharmacovigilance

•   Sources of data
•   Data integration and inter-operability
•   AI and machine learning
•   Causal inference and advanced statistical techniques
•   Health equity in PV
•   Social media as a data source
•   Digital tools for PV

KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

AI - PHARMACOVIGILANCE

10:00 – AI Innovation in Pharmacovigilance

•   Reflections of the expected impact of GenAI in Pharmacovigilance
•   Pitfalls to avoid
•   How to prepare your organisation for GenAI

SUZANNE FONCIN, Scientific Director, Safety Evaluation & Risk Management, GSK

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

10:30 – Morning Coffee / Tea & Discussion

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

RISK MANAGEMENT & PLANNING

11:00 – Keynote Panel Discussion: Risk Management – Planning for a risk-free tomorrow

•   Risk management compliance: From global strategy to local implementation
•   Managing RMP commitments, tracking risk minimisation measures globally, and evolving to stay ahead of the dynamic landscape
•   Bridging compliance gap in risk minimisation measures
•   Methodologies for patient- centered risk management communication
•   Patient-Perspectives in benefit-risk assessments with patients
•   Risk management in different jurisdictions/New approaches to managing benefit-risk
•   Tools, Approaches & Guidance on risk management plans
•   Tailored approaches towards benefit-risk evaluations
•   Measuring the effectiveness of risk minimization measures (RMMS)

Moderator
MIRCEA CIUCA, Global Head Medical Safety, Organon

Panellists
ROHAN MANE, Director of Risk Management, Regeneron
LEA GALOVIC, Associate Director, Risk Management, Global Patient Safety & PV, Teva
NICOLE BAKER, CEO, Biologit
SUZANNE FONCIN, Scientific Director, Safety Evaluation & Risk Management, GSK
REEM YASIN, Quality Assurance & PV Manager, Kawkab Group

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

AI

11:50 – Navigating the AI regulatory Landscape

MINHAJ OBEIDULLAH, Global Head Governance & Risk, Novartis

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

12:20 – PV Audits in the USA

•   Evolution
•   Challenges
•   Opportunities
•   Topics specific to USA audits (e.g. REMS)

HEATHER MURPHY, Founder and CEO, HMGlobal Pharmacovigilance Consulting

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

12:50 – Networking luncheon

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

13:40 – Reporting of Aggregate Safety Data in Clinical Trials

PHILIP JONES, Disease Area Cluster Lead, CVMWH, SSRM, WMS, Pfizer

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

14:10 – Transformation of Local PV Teams Role

•   The need to transform local PV teams into more scientifically-driven and collaborative roles to adapt to the evolving pharmaceutical industry
•   Challenges and opportunities in the healthcare landscape, including complex regulations and technological advancements
•   Growing complexity of risk management activities and the importance of local PV teams in navigating global regulatory environment
•   Automation and outsourcing trends with a focus on ensuring oversight
•   Potential actionable steps to transform local PV teams role

BEGUM BENLI PEKER, Head of Patient Safety Netherlands & EU Hub, Bristol-Myers Squibb

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

REGULATORY

14:40 – Keynote Panel Discussion: Regulatory - UK and EU Regulations & Guidelines in Pharmacovigilance

•   Staying ahead in the race - Current and new trends for PV and future guidelines
•   Balance between PV & recent legislations
•   Navigating dynamic regulatory landscape swiftly and effectively
•   Real World Data to Real World Evidence
•   AI & Regulatory – Recent legislations
•   Challenges in communications between pharmacovigilance and regulatory departments
•   Enhancing communication between regulators, regional authorities and patients & its importance
•   Future Legislation: Pharmacovigilance – Industry Vision

Moderator
PAV RISHIRAJ, Director, Head of Pharmacovigilance, Ipsen

Panellists
MICHAEL BEAN, Senior Director, Regulatory Compliance, Johnson & Johnson
MINHAJ OBEIDULLAH, Global Head Governance & Risk, Novartis
STEPHANIE MILLICAN, Deputy Director Benefit Risk Evaluation II Safety & Surveillance Group, MHRA
TERESA SARAGOCA, Director, Regulatory Affairs & Technical Manager, ITALFARMACO
ALEXANDER ROUSSANOV, International Partner, Life Sciences & Privacy, Arnold & Porter

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

15:30 - Chairperson’s closing remarks

13th February 37th Pharmacovigilance UK & EU 2025 – Day 2

15:40 – Evening Tea / Coffee & end of the conference

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

08:00 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

09:00 – Chairperson opening remarks

PAV RISHIRAJ, Director, Head of Pharmacovigilance, Ipsen

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

IMPACT OF TECHNOLOGY

09:10 – “New technologies in Pharmacovigilance” - “Automated tool for probabilistic causality assessment”

•   Development of the probabilistic tool.
•   Automation of the tool with the use of Large Language Model and predefined datasheets
•   Comparison of AI-driven automated vs human manual assessment
•   Use of the tool to carry out an automated screening of signals in medium/small safety databases

FABIO DE GREGORIO, VP, Head of Drug Safety Europe, Shionogi Europe

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

BEYOND COMPLIANCE

09:40 – Beyond Compliance: Transforming Regulatory Obligations into Meaningful Pharmacovigilance Actions

In the realm of pharmacovigilance, regulatory compliance is often perceived as a series of mandatory tasks—a “tick-box exercise” that ensures adherence to legal requirements. However, true patient safety and effective risk management demand more than just meeting regulatory standards. This presentation explores the paradigm shift from mere compliance to the implementation of impactful pharmacovigilance practices. Using the distribution of RMP educational materials as a case study, we will demonstrate how transforming regulatory obligations into meaningful actions can enhance patient safety, improve healthcare outcomes, and foster a culture of proactive risk management.

SABINE POLTERMANN, Head of Country Patient Safety Switzerland, Bristol-Myers Squibb

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

10:40 – Morning Coffee / Tea & Networking

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

LATEST UPDATES & HOT TOPICS

11:10 – Keynote Panel Discussion: Latest updates and hot topics - A new era of Pharmacovigilance

•   Current Challenges & Opportunities - Pragmatic Approaches
•   A review of general issues and the specific challenges
•   PV audits and inspections - What is the current focus of PV inspectors?.
•   Patients involvement for a better PV knowledge - Patient support programs
•   Innovative technologies and systems
•   Key challenges and areas of focus
•   Issues with implementation of a global PV System while remaining compliant with global regulations
•   Best practices & the way forward

Moderator
PAV RISHIRAJ, Director, Head of Pharmacovigilance, Ipsen

Panelists
VALENTINA MANCINI, Senior Director Pharmacovigilance, QPPV, Shionogi Europe
VIJAY SINGH, Former Associate Director, Product PV Device Digital Safety, UCB
TEA BABIC, Director, PV Audits and Inspections, Teva
RUDI SCHEERLINCK, Safety Strategy Lead – Oncology, Merck Group
PETAR GJORGIEV, Global Safety Lead, Regeneron
SANJEEV SRIVASTAV, Signal Management Lead, BioNTech

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

12:00 – 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.
•   Get insights into the dawn of Agentic AI and its potential as the next positive disruptor for automation.
•   Learn about ArisGlobal's commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.

JASON BRYANT, VP Data & AI, ArisGlobal

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

12:30 – Networking luncheon

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

13:30 – Panel Discussion – Next generation pharmacovigilance for enhanced patient safety and product quality

•   Reshaping patient safety and driving patient centricity into your PV plans
•   Quality, Safety, Signal Detection - Traditional and innovative approaches
•   Looking at importance of patient experience as a vital factor for quality and safety
•   Prioritising patients in the quest to achieve Patient Safety
•   Safety implementation: Approaches, best practices, and business considerations
•   Safety reporting in patient support programs

Moderator
YVONNE NANCIU, Country Head Pharmacovigilance Deputy EU QPPV, Bayer

Panellists
FABIO DE GREGORIO, VP, Head of Drug Safety Europe, Shionogi Europe
LEONARDO PEREIRA, Clinical Safety Director, Roche
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
SUMIT MUNJAL, Global Head of Medical Safety, Otsuka Pharmaceuticals

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

14:20 – ‘Harnessing RWD for Enhanced Risk Management and Drug Safety’

•   Utilizing RWD in pharmacovigilance enhances signal detection capabilities, enabling early identification of potential safety issues, risk confirmation/characterization and allowing for timely interventions.
•   Examples of RWD use in drug safety by MAH/Sponsor & Heath Authorities
•   The integration of RWD use across the molecule lifecycle
•   Pro-active use of RWD to address a safety concern versus reactive use of RWD to address a Heath Authority request

LEONARDO PEREIRA, Clinical Safety Director, Roche

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

14:50 - Afternoon Tea / Coffee

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

OUTSOURCING

15:20 - Panel Discussion – The era of outsourcing: recent developments and insights

•   Building a healthy global partnerships with your local affiliates
•   Outsourcing in Pharmacovigilance- Best Practices, Challenges and key consideration
•   Proper communication between - Sponsor – Site – CRO & Patients
•   Communication: Vital key to your PV system
•   Best Practices in Pre-Screening before selecting your partner
•   How can you maximize the effectiveness of your partnership?
•   Working together to improve drug safety & Mistakes that will doom a CRO-Sponsor partnership
•   Collaboration among all the parties (industry, regulators, patients, healthcare professionals, WHO, etc

Moderator
GURPREET SINGH, VP, Managing Director Integrated Safety, IQVIA

Panellists
PHILLIP EICHORN, Global Head of Drug Safety, Amryt Pharma
SIMON ASHWORTH, Head of Pharmacovigilance & Medical Safety, MENARINI Group
KAPIL BHUTADA, Head of Pharmacovigilance Safety Operation & Compliance, Asklepios BioPharmaceutical
MARGHERITA D’ANTUONO, EU-UK QPPV, Piramal
SANDY EISEN, Chief Medical Officer, CNS Consult

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

JAZZ PHARMA PERSPECTIVE

16:00 – Evening Keynote Panel Discussion: Reaching more patients and Role of PV and Regulatory Affairs Preparing for Geographical Expansions

•   Navigating regulatory landscape in the Cannabinoid space
•   Real World Data to Real World Evidence
•   Challenges in communications between Internal and External Stakeholder
•   Future opportunities and enhancements

Moderator
RAJ BHOGAL, Sr. Director, R&D Business Strategy & Operations, Jazz Pharmaceuticals

Panellists
ILARIA GRISONI, Exec Dir, Head of EU/INT PV & QPPV Office and EEA QPPV, Jazz Pharmaceuticals
MARK DANIELS, Director, Safety Physician, Medical Safety, Jazz Pharmaceuticals
RICHARD JELLEY, Sr Dir, Global Regulatory Strategy, Jazz Pharmaceuticals
CLAIRE BEGGS, Executive Director, Regulatory Affairs, INSPIRE, Jazz Pharmaceuticals

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

16:50 – Chairperson’s closing remarks and end of conference

12th February 37th Pharmacovigilance UK & EU 2025 – Day 1

17:00 – 18:15 – Networking Drinks Session

07th November 36th Pharmacovigilance 2024 – Day 2

08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.

07th November 36th Pharmacovigilance 2024 – Day 2

09:40 – Impact of immunogenicity on biosimilar safety and pharmacovigilance

ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories

07th November 36th Pharmacovigilance 2024 – Day 2

IMPACT OF TECHNOLOGY

10:10 – Panel Discussion - Technology: Unlocking the better ways in PV

•   How long can AI, process automation and improvements give a hand in PV?
•   Digital Adverse event monitoring and Electronic Health Records – What are the risks and benefits?
•   ML in patient monitoring: How do industrial experts see this?
•   Regulatory decision – making: In what way AI makes the path easier?
•   Data management and control in PV
•   Solving the challenges in PV by using Cloud

Moderator
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare

Panellists
RASHMI HEGDE, Former Executive Vice President Medical Affairs, GSK
KIRAN KANDULA, Senior Director, Pharmacovigilance, ProPharma
PROTITI BAGCHI, Associate Director- Global Content and Marketing Excellence, GSK
GIRIJESH SRIVASTAVA, Senior Manager - Global Supply Chain | Digital Transformation, Sun Pharmaceuticals
MANGALA KOTNIS, Former Head Regional Medical Affairs, Abbott

07th November 36th Pharmacovigilance 2024 – Day 2

11:10 – Morning Coffee / Tea & Discussion

07th November 36th Pharmacovigilance 2024 – Day 2

AUDITS & INSPECTIONS

11:40 – Panel Discussion - Managing Pharmacovigilance Audits & Inspections

•   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?

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
JYOTSNA PATWARDHAN, Cluster Head Clinical / PV QA at Africa, Middle East, Turkey & India, Novartis
VIVEK GUPTA, Associate Director, Clinical / Medical Affairs / Outcomes Research Vendor Relationship, Organon
JOYDEEP SENGUPTA, Global Pharmacovigilance - Site Head, Sun Pharmaceuticals
AMIT JAISWAL, Global Head Internal Audit, Cipla
SUNIL NIGHOT, Manager, ICSR Quality, Kenvue (Division of J&J)
SAVITA GUPTA, Head - Quality Assurance, OrciMed Life Sciences

07th November 36th Pharmacovigilance 2024 – Day 2

QUALITY - SAFETY

12:30 – From Compliance to Excellence: The future of Patient Safety

•   Introduction to Patient Safety
•   What has changed
•   Fundamentals remain unchanged
•   Shift the focus
•   Implementation strategy
•   Conclusion and take aways

ANJU AGARWAL, Global Director, Global Patient Safety, Advanz Pharma

07th November 36th Pharmacovigilance 2024 – Day 2

13:00 – Networking luncheon

07th November 36th Pharmacovigilance 2024 – Day 2

RISK MANAGEMENT

14:00 – Panel Discussion - Risk Management – Minimizing risk for better tomorrow

•   Implementation and maintenance of RMP’s – Overcoming its challenges
•   One RMP to fit all or all to fit within one RMP?
•   Benefit/Risk ratio: the common denominator
•   Implementing a Risk-Based Monitoring Solution: Understanding the basics of a sustainable model
•   Key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision
•   The “Next Generation” risk management tools
•   Manage Risks and enhance engagement through various successful approaches
•   Risk Evaluation and Mitigation Strategies (REMS): Lessons to learn today

Moderator
RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser

Panellists
RAMESH JAGANNATHAN, VP Clinical Research & Pharmacovigilance, Bharat Serums and Vaccines
JEROZE DALAL, Head of Clinical Operations, Governance & Risk Management, GSK
SIVA KUMAR BUDDHA, Director PV, Head of Signal & Risk Management, Indegene
ABHIJIT SURWADE, Manager Global Pharmacovigilance, Colgate-Palmolive

07th November 36th Pharmacovigilance 2024 – Day 2

14:50 – Pharmacovigilance in the Era of Personalized Medicine

JYOTI KASHID, Manager, Global Patient Safety Operation, Lundbeck (Singapore)

07th November 36th Pharmacovigilance 2024 – Day 2

15:20 – Afternoon Tea / Coffee

07th November 36th Pharmacovigilance 2024 – Day 2

OUTSOURCING

15:40 – Panel Discussion – PV and Outsourcing - How to evaluate and implement sourcing alternatives?

•   Benefits and risks of managing a pharmacovigilance-outsourced organization
•   Steps to be taken in order to maintain efficacy and quality
•   Outsourcing - Best Practices, Challenges and key consideration in choosing right vendor
•   Preliminary set up steps – What are all to be looked into?
•   Future of the field of pharmacovigilance, with a focus on how collaborations can work to advance the industry in this space?
•   Updates & lessons learned from novel approaches for collaborations while outsourcing
•   Outsourcing vs Innovation
•   Importance of Proper communication between - Sponsor – Site – CRO – Patients

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
MUKESH GORI, Director ESP Engagement PS & PV, Novartis
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
RAHUL SOMANI, Head- Global Pharmacovigilance, Alkem Laboratories
SADANAND KULKARNI, Head- Medical, Regulatory, Vigilance and Quality, Fresenius Kabi
VYNIE ANN RAO, Drug Safety & Risk Management Manager, Lupin

07th November 36th Pharmacovigilance 2024 – Day 2

16:30 – Closing remarks and end of conference

06th November 36th Pharmacovigilance 2024 – Day 1

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

06th November 36th Pharmacovigilance 2024 – Day 1

09:20 – Welcome Address

06th November 36th Pharmacovigilance 2024 – Day 1

EVOLUTION

09:30 – Evolution of the PV ecosystem

•   The PV ecosystem has evolved and requires a mindset shift – are you ready for the change?
•   What to expect in the next 5 years?
•   Key Challenges and industry best practices

KHAUDEJA BANO, Vice President - Global Head of Device Quality, Roche - Genentech (USA)

06th November 36th Pharmacovigilance 2024 – Day 1

CHALLENGES & OPPORTUNITIES

10:10 – Keynote Panel Discussion: New Era of PV’s Challenges / Opportunities - Turning strategy into execution

•   Discussion on strategies to address pharmacovigilance challenges in the long-term
•   What comes next for the industry?
•   Automating pharmacovigilance: Are we ready for the upcoming future?
•   Moving forward in Drug Safety – Where are we heading and which is the right direction?
•   Current challenges and goals in the field and to identify ways for betterment
•   Moving towards a better future: bigger and better
•   Best practices & lessons learnt today

Moderator
VIPIN SETHI, Vice President, Cadila

Panellists
PRABHAT SINHA, Director Government & Public Affairs, Boehringer Ingelheim
SAKSHI SHRIVASTAVA DESAI, Associate Director International Pharmacovigilance Strategy Realization, Johnson & Johnson
ROHINI PANDEY, Regional PV Head, Abbott
ANUJA JAWALE, Associate Director - RA / PV Strategic Engagements & Vendor Management, Organon
SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz

06th November 36th Pharmacovigilance 2024 – Day 1

11:00 – Morning Coffee / Tea & Discussion

06th November 36th Pharmacovigilance 2024 – Day 1

PATIENT SAFETY

11:30 – Keynote Panel Discussion: Enhancing patient centricity & patient safety

•   The What, Why, and How - Reduce Barriers and move towards prioritising patients
•   Protecting patients and pharmacovigilance compliance in extraordinary circumstances
•   Next generation pharmacovigilance for enhanced patient safety
•   Strategy for improving your organization’s patientfacing communications
•   Discuss specific methodologies frequently used in the development of patient safety program
•   Encouraging patient support programs in Pharmacovigilance
•   A practical approach to reshaping patient safety
•   Educating stakeholders via patient stories

Moderator
DILIP PAWAR, Former Head - Medical Affairs & Pharmacovigilance, Unichem Laboratories

Panellists
VAIBHAV SALVI, Director & Head - Clinical Study Unit, India & South East Asia, Sanofi
SOURABH FULMALI, Global Medical Director – Respiratory, GSK
INDU NAMBIAR, Pharmacovigilance Lead and Country Safety Head, Sanofi Consumer Healthcare India
RENUKA NEOGI, Head & Deputy GM – Global Clinical Quality Management, Sun Pharma
ASWIN KUMAR, Head-Global Medical Writing, Viatris

06th November 36th Pharmacovigilance 2024 – Day 1

12:20 – Pharmacovigilance in Europe - key steps for essential compliance

LUDKA FYLES, Senior VP Pharmaceutical Affairs, Vizen Life Sciences (Europe)

06th November 36th Pharmacovigilance 2024 – Day 1

12:50 – Networking luncheon

06th November 36th Pharmacovigilance 2024 – Day 1

RWD / RWE

13:50 – Panel Discussion - Real World Data to Real World Evidence

•   Importance of real-world data for answering regulatory questions
•   Benefits and challenges of evidence derived from real world sources compared to clinical trials.
•   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.

Moderator
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences

Panellists
PRATIK SHAH, VP Medical Affairs, Bharat Serums and Vaccines
SANTOSH TAUR, Director Medical Affairs, Pfizer India & Chair RWE Council, ISCR
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
SANKET NEWALE, Head Medical Affairs & Business Compliance, Wockhardt
VANSHIKA BRIJWANI, Manager Country Development Quality (CDQ), Novartis
KUSHAL SARDA, GM & Head - Medical Affairs, Clinical Research & PV, Shalina Healthcare

06th November 36th Pharmacovigilance 2024 – Day 1

MEDICAL DEVICES

14:40 – Perspectives of Materiovigilance

•   Pharmacovigilance and Emergence of Materiovigilance
•   Understanding Materiovigilance
•   Global Regulations on materiovigilance
•   Materiovigilance in India

APARNA PRABHUNE, Assistant General Manager – Regulatory Affairs, Wockhardt

06th November 36th Pharmacovigilance 2024 – Day 1

15:10 – Afternoon Tea / Coffee

06th November 36th Pharmacovigilance 2024 – Day 1

15:40 – “Embracing and Integrating AI and technology for patient safety”

SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz

06th November 36th Pharmacovigilance 2024 – Day 1

REGULATORY

16:10 – Keynote Panel Discussion: PV - Regulatory Updates – Transforming regulatory strategy to meet the evolving landscape in Prioritising Patients

•   Key current changes and their impact on current PV
•   Integrating patient focus into the regulatory mindset
•   Regulations on adverse events / Guidelines for critical medicines
•   Future Legislation: Pharmacovigilance Industry Vision
•   PV system legislation updates
•   Improving communication between regulators, regional authorities and patients
•   Standardizing and streamlining the regulatory process
•   What’s next? Ways to proceed forward.

Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates

Panellists
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
SHIRAZ KANDAWALLA, Head of Regulatory, Quality, Safety, Ferring Pharmaceuticals
SANJAY MENON, Country Head Patient Safety, Novartis
JYOTI KASHID, Manager, Global Patient Safety Operations, Lundbeck (Singapore)
SANTOSH J. SACKET, Director – Quality Assurance & Innovation, Expecto Health Science

06th November 36th Pharmacovigilance 2024 – Day 1

17:00 – Welcome address for Networking Drinks

4C Pharma Solutions

06th November 36th Pharmacovigilance 2024 – Day 1

17:05 – 18:15 – Networking Drinks