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Wednesday, June 18
 

8:30am EDT

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.

Learning Objectives

Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS; Describe how to prepare and be ready to submit electronically; Discuss reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Industry Perspective: ICH E2B R3 Regional Implementations
Donald Williams

Beyond Borders: Navigating the Complexities of ICH E2B R3 Regional Implementations
Una Kessi


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
UK

Una Kessi

Product Management Director, Safety and Pharmacovigilance, Oracle Health & Life Sciences, United Kingdom
Una works as a Product Management Director, Safety and Pharmacovigilance, at Oracle Health and Life Sciences. Her main focus is on Regulator Strategy, Safety and PV Regulations, Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also... Read More →
DW

Donald Williams

Global Patient Safety and Pharmacovigilance, Regulatory Reporting, Boehringer Ingelheim Pharmaceuticals, Inc., United States
Donald Williams currently works in the Global Patient Safety & Pharmacovigilance department of Boehringer Ingelheim Pharmaceuticals, Inc. He is a member of the Regulatory Reporting Team, and his responsibilities include overseeing ICSR submission activities and monitoring global regulatory... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Basic

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Discuss improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy).

Chair

Allison Cuff Shimooka, MBA

Speakers
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

8:30am EDT

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.

Learning Objectives

Discuss the Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Explain the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Identify strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Claudia Ana Ianos, MD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Carmit Strauss, PharmD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Scott Evans, PhD, MS


Speakers
avatar for Scott Evans

Scott Evans

Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute of Public Health, United States
Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer Inc, 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 →
avatar for Carmit Strauss

Carmit Strauss

Executive Director, Head of Risk Management and Organ Toxicity, Takeda, United States
Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the Risk Management and Organ Toxicity centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety, Pharmacovigilance and Medical Affairs. Carmit participants... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speakers
WB

William Blumentals

Head of Pharmacoepidemiology, Special Care, Sanofi, United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Trustworthy AI Solutions for Next-Generation Pharmacovigilance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

Despite advances in AI and Generative AI, its routine use in pharmacovigilance (PV) and high-risk applications is limited. This session will explore what’s needed to enable trusted use, highlighting technical challenges with multistakeholder input.

Learning Objectives

Demonstrate and discuss how Generative AI can facilitate the future approach in augmenting PV systems in a trusted, compliant, and transparent manner; Summarize the opportunities and challenges with such an approach.

Chair

Jens-Ulrich Stegmann, MD, RN

Speakers
avatar for Jens Stegmann

Jens Stegmann

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium
Jens-Ulrich Stegmann, MD, RN, is Senior Vice President, Head of Clinical Safety and Pharmacovigilance, and EU QPPV at GSK, Belgium. With an M.D. in nursing from the University of Essen and a Ph.D. in Physiology from Christian-Albrechts University in Kiel, Germany, Jens began his career... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Panelist
François Houyez

Panelist
Anja Schiel, PhD


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for François Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France
François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also... Read More →
avatar for Anja Schiel

Anja Schiel

Special Advisor, Lead Methodologist/Statistician; NoMA, Norwegian Medicines Agency (NoMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   01: ClinSafety-PV, Session

12:00pm EDT

Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Clinical Safety & Pharmacovigilance Community for a follow up round table discussion tied to session: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships (Tuesday June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PhD

Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   01: ClinSafety-PV, Session

1:45pm EDT

Addressing Challenges in Devices Safety Monitoring
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Discuss and assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Speaker

Industry Perspective
Khaudeja Bano, DrMed, MD, MS

WHO Perspective
Hiiti Sillo, MSc, RPh


Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Genentech, United States
Dr. Bano is the Global Head - Vice President of Device / Combination product Quality at Genentech / Roche. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional... Read More →
avatar for Hiiti Sillo

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Discuss the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Recognize how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson, PhD

Panelist
Szczepan Baran


Speakers
SB

Szczepan Baran

Tech4Pets, Chief Barks and Purrs Officer, United States
avatar for Julie Frearson

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Judy Shin, PhD

Speaker

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh


Speakers
BK

Bonggi Kim

Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of
avatar for Jeff Lange

Jeff Lange

Director of Observational Research in Asia, Amgen, Hong Kong
Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the... Read More →
avatar for Min-Jung Lim

Min-Jung Lim

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of
avatar for Judy Shin

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
SW

Shinya Watanabe

Reviewer (Epidemiology), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinya Watanabe is an epidemiologist at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. He conducts pharmacoepidemiological studies using medical information databases, such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   01: ClinSafety-PV, Session

1:45pm EDT

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Chair

Sophie Radicke, MSc

Speaker

Health Canada Perspective
Myriam Salem, MSc


Speakers
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   01: ClinSafety-PV, Session

4:00pm EDT

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.

Learning Objectives

Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.

Chair

Daniele Sartori, MPharm

Speaker

Computerized Labeling Assessment Using AI
Suranjan De, MBA, MS


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
DS

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre, 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 →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
 
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  • 00: Plenary
  • 01: ClinSafety-PV
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