DIA 2026 Global Annual Meeting: Full Schedule

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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

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

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 →

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

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 →

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
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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
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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

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 →

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

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 →

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
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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