DIA 2025 Global Annual Meeting: Full Schedule

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1:45pm EDT

#340: 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

201

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-640-L04-P; CME 1.00; RN 1.00

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

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

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

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

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

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

Min-Jung Lim is the CEO and Senior Pharmacovigilance Consultant at MediSafe, with over 25 years of experience in clinical research and pharmacovigilance. She previously led drug safety functions as Head of Pharmacovigilance & Post Marketing Studies at GSK Korea. She also serves as... Read More →

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
201 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
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulatory Convergence and Harmonization,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

#345: Africa's Evolving Regulatory Landscape

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

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-645-L04-P; CME 1.00; RN 1.00

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

Janis Bernat, MSc

Speaker

Panelist
Bunmi Femi-Oyekan

Panelist
David Mukanga, PhD, MPH

Panelist
Grace Matimba, MS

Panelist
Chimwemwe Chamdimba

Speakers

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland

Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →

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 →

Bunmi Femi-Oyekan

Senior Director Accord & Access Regulatory Lead, Pfizer Specialities Ltd, Nigeria

Bunmi Femi-Oyekan is a pharmacist with over 32 years of experience in the pharmaceutical industry, primarily in regulatory, sales, and safety, currently serving as the Regulatory Lead, Accord and Access for Pfizer. She is responsible for development and execution of regulatory strategies... Read More →

Grace Matimba

Chief Regulatory Officer, Medicines Control Authority of Zimbabwe, Zimbabwe

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB 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
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulator Perspectives,Regulatory Reliance,Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

4:00pm EDT

#365: 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

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-661-L04-P; CME 1.00; RN 1.00

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.

Chair

Ralf Herold, DrMed, MD

Speaker

How Industry Is Shaping Public-private Partnerships To Facilitate New Development Pathways For Products
Ginny Beakes-Read, BSN, JD

The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges
Louis Stancato, PhD

Accelerating Translation of Regulatory Science Research – EFPIA’s perspective
Solange Corriol-Rohou, DrMed, MD, PhD

Speakers

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →

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 →

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands

Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →

Louis Stancato

VP Enabling Technologies, Indiana Biosciences Research Institute, United States

Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB 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
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Forum

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