DIA 2025 Global Annual Meeting: Full Schedule

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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

Bonggi Kim

Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of

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 →

Min-Jung Lim

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of

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 →

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

Level Intermediate
Keyword Global Perspectives, Regulatory Convergence and Harmonization, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Feature Topics Global Perspectives,Regulatory Convergence and Harmonization,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

Africa's Evolving Regulatory Landscape

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Saba Berhane, BSN, MPharm

Speaker

Panelist
David Mukanga, PhD, MPH

Speakers

Saba Berhane

Manager, Regulatory Affairs, IFPMA, Switzerland

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... 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

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulator Perspectives, Regulatory Reliance, Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Feature Topics Regulatory Collaboration ,Regulator Perspectives,Regulatory Reliance,Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

4:00pm EDT

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.

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

09: Regulatory, Forum

Level Intermediate
Keyword Regulator Perspectives, Regulatory Convergence and Harmonization, Student Programming, Global Perspectives
Level Intermediate
format csv
Feature Topics Regulator Perspectives,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Forum

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