DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-551-L04-P; CME 1.00; RN 1.00

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

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

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

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

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-562-L04-P; CME 1.00; RN 1.00

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 Patel, PharmD

Speaker

Panelist
Suranjan De, MBA, MS

Panelist
Andrew Bate, PhD, MA

Panelist
Phil Tregunno

Panelist
Jeremy Jokinen, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-563-L04-P; CME 1.00; RN 1.00

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
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-593-L04-P; CME 1.00; RN 1.00

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

FDA Medical Queries (FMQs)
Linda Jeng, MD, PhD

Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MEd, MPH

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-601-L04-P; CME 1.00; RN 1.00

A rare opportunity to hear inspectors from three global regulators and a European industry association compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts. It is well recognized that pharmacovigilance is a global activity; however, the regulation of pharmacovigilance (PV) still occurs very much at a country-specific level. Regulation is enforced by inspectors in each country which results in organizations being inspected frequently by multiple regulators. Inspectors from three global world-renowned regulatory agencies (US FDA, Health Canada, UK MHRA) will come together in this fireside chat in a rare opportunity to hear inspectors’ perspectives and how they can envision working together to ensure the systems in place are adequately capturing safety issues. The regulator perspective will be complemented by industry views from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Discussions will focus on differences and similarities in inspection styles and requirements across the three regulators, including inspector expectations and conduct of inspections. You will have the opportunity to hear from inspectors about key emerging issues. Common inspection trends will be discussed highlighting areas where inspectors see compliance issues across all three regulators. There will be a chance to hear from the panel discussing the future of inspections, including hot topics such as AI and new initiatives in each of the respective regions . Discussions will also focus on collaboration efforts, such as efforts to reduce burden on industry and looking into the future about upcoming best practices in pharmacovigilance. The audience will have a chance to pose questions to panel members to gain simultaneous insights from regulators and industry.

Learning Objectives

Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators and understand their impact on industry; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.

Chair

Sophie Radicke, MSc

Speaker

Industry Perspective
Carrie Scott

FDA Perspective
Namita Kothary, PharmD, RAC

Health Canada Perspective
Stephane Berard, MS