DIA 2026 Global Annual Meeting: Full Schedule

11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?

Monday June 15, 2026 11:00am - 12:15pm EDT

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25

This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care.

Learning Objectives

Describe the changes in availability and use of different data sources for safety surveillance across the healthcare landscape in the future; Identify the challenges for data collection, monitoring and assessment of safety data from evolving real world use of healthcare products; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.

Chair

Alison Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Forum | 03: Data-Tech-AI, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Data Management & Data Standards
Tags Forum

2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

Monday June 15, 2026 2:30pm - 3:30pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00

The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.

Learning Objectives

Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports; Describe a practical framework for critically appraising of AI models and systems, with focus on risk based approaches, human oversight, validity and robustness, transparency, data privacy, fairness and equity and governance.

Chair

Phil Tregunno

Speaker

Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC

Panelist
Beth Anne MacEntee Pileggi, BSN, MBA

Panelist
Walter Straus, DrMed, MD, MPH, FACP

Speakers

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden

Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States

Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →

Walter Straus

Vice President, Safety and PV, Moderna, United States

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning

Monday June 15, 2026 4:00pm - 5:00pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00

This session shares US, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female, young and older patients) in local contexts.

Learning Objectives

Describe needs and methods for tailoring risk minimization interventions to special patient populations; Recognize challenges and opportunities of digital support to implementing risk minimization interventions with examples; Discuss experiences from around the globe with localization of risk minimization interventions and reliance.

Chair

Priya Bahri, PHD

Speaker

Panelist
Shelley Gandhi, MS

Localisation of risk minimisation interventions – Low- and middle-income countries and global reliance
Jean-Christophe Delumeau, MD, PHD

Tailoring risk minimisation interventions - Applying implementation science and user-testing
Meredith Yearsley Smith, MPA, FISPE

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda

Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic

Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Rare Disease & Special Populations
Feature Topics Patient-Centered Design and Experience
Tags Session

10:15am EDT

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration

Tuesday June 16, 2026 10:15am - 11:30am EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P; CME 1.25; RN 1.25

This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.

Learning Objectives

Identify algorithmic innovations that address signal detection challenges in vulnerable populations; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.

Chair

Ju-Young Shin, PHD

Speaker

Recent advances in PV innovation: implementing/deploying for practical impact
Raymond Kassekert, MBA

A method for systematically retrieving pregnancy-related reports
Daniele Sartori, MSC

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Raymond Kassekert

Executive Director, PV Systems Management, GSK, United States

Ray is Executive Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the MedDRA... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Safety & Pharmacovigilance
Feature Topics Artificial Intelligence
Tags Session

10:15am EDT

#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing

Tuesday June 16, 2026 10:15am - 11:30am EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-558-L04-P; CME 1.25; RN 1.25

Learn how mixed FSP (functional service provider)/FSO (full-service outsourcing) models deliver additional agility to help clinical trial sponsors manage complexity, enhance efficiency, and facilitate the transition from FSO to FSP outsourcing.

Learning Objectives

Identify opportunities where mixed FSP (functional service provider)/FSO (full-service outsourcing) models create additional agility in clinical trial operations; Discuss how mixed FSP/FSO models facilitate the transition from FSO to FSP outsourcing; Assess flexible options to deliver drug development on time and on budget in complex, global trials.

Speaker

Moderator
Andrew Studna

Panelist
Samantha Hadfield

Panelist
Nick Scott

Speakers

Samantha Hadfield

Vice President, Operational Delivery, PPD FSP solutions, Thermo Fisher Scientific, United Kingdom

Nick Scott

Head, Strategic Resourcing and Performance Optimization, Biogen, United States

Andrew Studna

Senior Editor, Applied Clinical Trials, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 01: ClinSafety-PV-RM, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Tags Forum

1:45pm EDT

#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

118AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P; CME 1.25; RN 1.25

This session explores pharmacovigilance for biosimilars, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA, academia, and industry will discuss suffix-related challenges and future directions.

Learning Objectives

Describe the FDA’s nonproprietary naming convention for biological products and its intended role in pharmacovigilance; Analyze empirical evidence from FAERS to evaluate how suffix reporting impacts pharmacovigilance activities; Assess the role of naming conventions in broader active surveillance systems, such as the Sentinel System, and their implications for biosimilar safety monitoring.

Chair

Stacey Ricci, DRSC

Speaker

TBD
Mary Jo Carden, JD

TBD
Judith Maro, MS

TBD
Mariana Socal, MD, PHD, MS

Speakers

Mary Jo Carden

Carden Associates, United States

Mary Jo Carden is President of Carden & Associates. She previously served as Head of Policy at Sandoz, Inc., Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities... Read More →

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States

Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →

Stacey Ricci

Director, Scientific Review Staff, OTBB, CDER, FDA, United States

As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance... Read More →

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States

Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Advanced
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

4:15pm EDT

#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

118AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P; CME 1.00; RN 1.00

A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.

Learning Objectives

Discuss the challenges and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.

Chair

Sarah Vaughan

Speaker

Panelist
Michael Mittelman

Panelist
Peter Hjelmstrom, MD, PHD

Panelist
Lisa Wolf, PHARMD

Speakers

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre (UMC), Sweden

Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →

Michael Mittelman

Chairman, American Living Organ Donor Fund, United States

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Lisa Wolf

Deputy Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States

Dr. Lisa Wolf joined the Division of Pharmacovigilance-I (DPV-I), Center for Drug Evaluation and Research, US Food and Drug Administration in 2016, where she served as a Safety Evaluator for gastroenterology products, followed by Team Leader covering multiple therapeutic areas, and... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Forum

Audience Basic
Area Patient-Centered Design and Experience
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
Feature Topics Patient-Centered Design and Experience
Tags Forum

4:15pm EDT

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P; CME 1.00; RN 1.00

In this session, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating enabler for the business and patients.

Learning Objectives

Recognize the value unlocked by the incorporating AI and advanced analytics in GCP/GVP quality assurance; Describe the short and long term transformative benefits; Discuss how to develop strategies for demonstrating the value created by embedding AI and advanced analytics into quality assurance audits.

Chair

Roshan D'Souza

Speaker

Value realisation in augmenting Quality Assurance with advanced analytics & AI?
Frederik Collin, MS

Lessons learned in implementing advanced analytics & AI in Quality Assurance
Jeremy Jones, MS

The Why behind the Value proposition
Roshan D'Souza

Data & Digital: Assessing Measurable Value in QA
Michael Pelosi, MA, MBA

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States

Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States

Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

10:15am EDT

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures

Wednesday June 17, 2026 10:15am - 11:30am EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25

Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.

Learning Objectives

Discuss the US and EU regulatory rationale and expectations for RMM evaluations; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.

Chair

Daniele Sartori, MSC

Speaker

Panelist
Gita Toyserkani, PHARMD, MBA

Panelist
Elaine Lippmann, JD

Panelist
Helga Gardarsdottir, FISPE

Panelist
Priya Bahri, PHD

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands

Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →

Elaine Lippmann

Principal, Leavitt Partners, United States

Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States

Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
Tags Session

1:45pm EDT

#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-612-L04-P; CME 1.00; RN 1.00

This forum will explore how pharmacovigilance strengthens vaccine confidence and reduces hesitancy through safety monitoring, transparent communication, and healthcare professional training, with lessons from Brazil and international perspectives.

Learning Objectives

Describe how pharmacovigilance can strengthen vaccine confidence and address hesitancy; Identify strategies to empower healthcare professionals to improve safety data reporting; Discuss global and national approaches to transparent risk–benefit communication in immunization.

Chair

Mayra Martho Moura Oliveira, BSN

Speaker

Pharmacovigilance as a Trust-Building Tool: From Surveillance to Confidence
Patrícia Mouta Nunes Oliveira, MD

The role of healthcare professionals: how training and information dissemination transform trust in vaccines.
Vera Lúcia Gattás, PHD

Speakers

Vera Gattás

QPPV, Instituto Butantan , Brazil

Graduated in Nursing from Escola Paulista de Medicina - Depto. Nursing (1979); Master in Public Health from the Faculty of Public Health of the University of São Paulo - USP (1996) and PhD in Tropical Diseases and International Health from the Institute of Tropical Medicine at USP... Read More →

Patricia Mouta

Pharmacovigilance specialist, Biomanguinhos/Fiocruz, Brazil

Dr. Patrícia Mouta is a Medical Doctor and Patient Safety specialist with extensive experience in pharmacovigilance and vaccine safety. Since 2011, she has worked as a Safety Physician at Bio-Manguinhos/Fiocruz, a leading public manufacturer of vaccines and biopharmaceuticals in... Read More →

Mayra Oliveira

pharmacovigilance manager, Instituto Butantan, Brazil

Since graduating as a nurse in 2007, I have built a solid career in immunization, working across different areas including vaccination clinics, clinical research coordination, and clinical operations management. Over the years, I progressed into vaccine safety and currently serve... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

4:00pm EDT

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P; CME 1.00; RN 1.00

This session will share insights into signal detection approaches across different product types, exploring how regulators, industry, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.

Learning Objectives

Describe challenges in performing signal detection activities across a range of healthcare product types, including devices, combination products, and advanced therapies; Discuss novel approaches and data sources to enhance signal detection; and identify opportunities to incorporate emerging signal detection approaches into your organization's vigilance activities.

Chair

Monica Munoz, PHARMD, PHD

Speaker

Panelist
Judith Maro, MS

Panelist
Jeffery L Painter, JR, JD, MSC

Speakers

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States

CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →

Jeffery Painter

Senior Director, Quantitative Leader for Safety Innovation & Analytics, GlaxoSmithKline, United States

Jeffery Painter is the Quantitative Leader for Safety Innovation and Analytics at GSK, advancing pharmacovigilance through Bayesian methods, semantic similarity, and ontology-driven analytics. He is the author of PVLens, a drug safety reference database derived from regulatory labeling... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Tags Session

4:00pm EDT

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

115AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00

Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.

Learning Objectives

Demonstrate the need for a continuous approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development

Chair

Claudia Ana Ianos, MD

Speaker

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD

Speakers

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States

Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer, United States

Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States

Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →

Diana Morgenstern

Head, Real World Evidence and Outcomes Research, Viatris, United States

Diana Morgenstern, MD, FACP is a general internist whose varied career includes depth and breadth in clinical practice, medical education, and strategic approaches to pharmaceutical industry medical affairs, including real world evidence generation to address care gaps. Dr. Morgenstern... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 01: ClinSafety-PV-RM, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Tags Forum

8:00am EDT

#700: Insights Regarding Implementation of the ASAP Process

Thursday June 18, 2026 8:00am - 9:00am EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00

We will focus on insights regarding implementation of the ASAP process, how it has been beneficial to implement, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).

Learning Objectives

Describe the steps to implement the ASAP process at a smaller company with limited resources; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts; Recognize how the ASAP process has been beneficial to implement for various projects.

Chair

Greg Ball, PHD

Speaker

Insights Regarding Implementation of the ASAP Process
Barbara Hendrickson, DrMed, MD

Advantages of Earlier Systematic and Strategic Safety Planning
Famina Hemani, PHARMD

Practical Implementation of ASAP Concepts
Shital Patel, PHARMD

Practical Implementation of ASAP Concepts
Cynthia McShea, MPH

Speakers

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Famina Hemani, PharmD, is a Pharmacovigilance leader with over 20 years of experience in pharmacy and biopharma, including more than a decade in strategic safety leadership. She has built and scaled PV functions from early clinical development through pre-commercialization across... Read More →

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Cynthia McShea

Head, Safety Statistics, UCB Biosciences, United States

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she... Read More →

Shital Patel

Associate Safety Lead, UCB, United States

Shital Patel

Associate Safety Lead, UCB Biosciences, United States

Thursday June 18, 2026 8:00am - 9:00am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:00am EDT

#701: No Report Left Behind: Human-Centered Safety Reporting

Thursday June 18, 2026 8:00am - 9:00am EDT

103A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00

Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation, safety processes, and clinical operations partner to reduce missed reports, protect patients, and strengthen trial integrity.

Learning Objectives

Identify the key factors that contribute to patients underreporting adverse events and assess the resulting impact on safety, operations, and compliance; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.

Chair

Lani Hashimoto

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Jennifer Miller, PHD

Speakers

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Feature Topics Patient-Centered Design and Experience
Tags Session

8:00am EDT

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You

Thursday June 18, 2026 8:00am - 9:00am EDT

117

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P; CME 1.00; RN 1.00

How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify, prioritise and effectively fix non-compliance in PV, exploring the role of psychological safety in this.

Learning Objectives

Describe how proactive approaches to investigating known issues, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.

Chair

Anna Adams, PHD

Speaker

Panelist
Manny Burga

Panelist
Andrew Cooper

Panelist
Helen Emery

Speakers

Anna Adams

Head, PV QA Europe, Daiichi Sankyo Co., Ltd., United Kingdom

As a senior leader in PVQA at Daiichi Sankyo, Anna is passionate about fostering a strong Quality Culture. Her group manages pharmacovigilance inspection readiness and PV compliance oversight, with transparency and proactive collaboration. She was previously Head of Performance and... Read More →

Manny Burga

Operations Executive, formerly J&J and Kenvue, Independent, United States

Andrew Cooper

Senior Director Business Partnering PV, Regulatory and Medical R&D, GSK, United Kingdom

Helen Emery

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Helen is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). Prior to joining the MHRA she spent several years in Industry, where she accumulated knowledge across the PV system. She held roles supporting the EU QPPV, which ultimately led... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Quality Assurance / Control & CMC
Tags Session