DIA 2025 Global Annual Meeting

Component Type: Session
Level: Basic

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PhD, MS, RPh, FISPE

Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PhD, MS

Component Type: Session
Level: Intermediate

This session will introduce the latest efforts to enhance the quality of safety signal generation from government, industry, and academia (e.g., recommendations, regulatory frameworks, case examples) and will conclude with a panel discussion.

Learning Objectives

Explain the latest recommendations for reporting the results of safety signal generation (transparency, completeness) and relevant case example; Examine case examples to enhance the quality of safety signal generation in industry and academia: task process and methodologies; Discuss perspectives from government, industry, and academia to enhance the quality of safety signal generation.

Chair

Judy Shin, PhD

Speaker

Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA

Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD

Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh

A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and beyond
Michele Fusaroli, DrMed, PhD

Component Type: Session
Level: Intermediate

This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.

Learning Objectives

Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.

Chair

Jamie Wilkins, PharmD

Component Type: Session
Level: Intermediate

The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.

Learning Objectives

Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.

Chair

Mayur A Patel, PharmD

Component Type: Session
Level: Intermediate

Risk mitigation (RM) decisions commonly lack conclusive data and reproducibility. This session presents regulatory initiatives, TRIM, the first tool to support RM decision-making, and case studies of evidence-guided RM implementation and evaluation.

Learning Objectives

Summarize new initiatives that support regulatory decision-making on risk mitigation; Explain the use of pharmacoepidemiologic and decision-science approaches in developing an explicit risk mitigation decision tool; Discuss how qualitative and quantitative evidence can support REMS implementation; Compare study design options for formal REMS evaluation.

Chair

Almut G Winterstein, PhD, RPh, FISPE

Component Type: Session
Level: Intermediate

We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).

Learning Objectives

Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.

Chair

Greg Ball, PhD

Speaker

PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS

PHUSE Safety Analytics Education Library
William Palo, MS

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

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
Carmit Strauss, PharmD

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

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

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

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

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

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

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

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

Component Type: Session
Level: Intermediate

Planning safety reviews for a compound developed for multiple diseases is complex, requiring consistency across studies and analyses. A compound-level Data Monitoring Committee ensures unblinded safety review consistency, while an Aggregate Safety Assessment Plan (ASAP) supports post-study assessments. This presentation explores how an ASAP was implemented across a program to enable ongoing safety profile development as studies complete. It also introduces an interactive R Markdown application for real-time aggregate reviews, aligning with new draft regulatory guidance. This approach provides reviewers with access to program-level and individual study data during development, improving safety oversight. Key topics include the importance of coordination, teamwork, and standards to maintain a reliable safety database. A "year in review" will highlight lessons learned and enhancements made, concluding with an example of the application’s interactive capabilities.

Learning Objectives

Recognize and apply the Aggregate Safety Assessment Planning (ASAP) concept to drug development and aggregate safety analysis; Discuss implementing the ASAP effectively within an organization; Identify and utilize the importance of an interactive application for performing ongoing aggregate safety reviews.

Chair

Robert (Mac) Gordon, MS

Speaker

Industry Perspective on the ASAP Process
Walter Straus, DrMed, MD, MPH, FACP

Overview of the ASAP Process
Greg Ball, PhD

Perspective on the ASAP Process
Y. Veronica Pei, MD, MEd, MPH