DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Intermediate

National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.

Learning Objectives

Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.

Chair

Amira Deia Younes

Component Type: Session
Level: Intermediate

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Kwaku Marfo

Component Type: Forum
Level: Intermediate

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speaker

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, DrMed

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm

Component Type: Session
Level: Intermediate

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

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

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

Component Type: Session
Level: Intermediate

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Component Type: Forum
Level: Basic

The Indonesian regulation for clinical research has shown a significant transformation during the past year, after practically being at a very low level for the past decade. The Ministry of Health, together with the Indonesian Drug and Food Regulatory Body are prepared to welcome global pharmaceutical companies to conduct researches in various hospitals in the country.

Learning Objectives

Discuss the recent transformations in Indonesian clinical research regulations and their impact on the country's research environment; Recognize the opportunities and challenges for global pharmaceutical companies conducting clinical research in Indonesia under the new regulatory framework.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Indonesia’s Health Research Revolution: Fast-Tracking Innovation & Global Collaboration in Clinical Trials
Budi Gunadi Sadikin, PhD

Indonesia’s Regulatory Readiness in Embracing Clinical Trial Transformation
Taruna Ikrar, MD

INA-CRC: The Catalyst of Indonesia’s Clinical Trial Ecosystem Transformation
Indri Rooslamiati Supriadi, MS, RPh

Strengthening Indonesia’s Clinical Research Quality: The Critical Role of Clinical Research Unit
Yuli Felistia, MD

Panelist
Ria Siagian

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.