DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Intermediate

Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.

Learning Objectives

Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6(R2) Good Clinical Practice, E17 Multi-Regional Clinical Trials and M4Q(R2); Identify opportunities for greater regulatory harmonization to advance global drug development.

Chair

Amanda Roache, MS

Speaker

US Regulatory Perspective on the Future of International Harmonization
Theresa Mullin, PhD

Industry Priorities for the Future of International Regulatory Harmonization
Wassim Nashabeh, PhD

ANVISA Perspective on International Global Harmonization and Future Opportunities
Marcelo Moreira, MS

Component Type: Forum
Level: Intermediate

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Recognize ways to gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

FDA Perspective on Best Practices for Navigating Divergent Regulatory Feedback
Namandjé Bumpus, PhD

Best Practices for Navigating Divergent Regulatory Feedback
Natalie Tolli, MS, RPh

Component Type: Session
Level: Intermediate

A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.

Learning Objectives

Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
Samantha Roberts, PhD

Component Type: Session
Level: Intermediate

Explore WHO-led initiatives and global collaborations driving regulatory harmonization and innovation to ensure equitable access to medical products. This session highlights strategic efforts to address shared challenges and advance global health.

Learning Objectives

Discuss the progress and challenges in achieving regulatory convergence and harmonization; Recognize the role of regulatory reliance and collaboration in facilitating access to medical products; Discuss international partner’s perspective on navigating regulatory landscapes to enhance global health equity.

Chair

Hiiti Sillo, MSc, RPh

Speaker

CIP Network and its role in Advancing Global and Regional Regulatory Harmonization, Collaboration, and Work-Sharing
Jude Nwokike, MPH, MSc, RPh, RAC

Regulatory Harmonization: Advancing Global Health through Collaboration
Marion Laumonier, MSc

Shaping Global Health Research and Development through WHO Resources and Coordinated Scientific Advice
Mercedes Perez Gonzalez, MSc

Component Type: Session
Level: Intermediate

This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.

Learning Objectives

Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.

Chair

Stephanie Choi, PhD

Speaker

Barriers and enablers in international RWE harmonization
Nicole Mahoney, PhD

Comparison of RWE guidelines across regions
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH Efforts in International RWE Harmonization
David Moeny, MPH, RPh

Component Type: Session
Level: Intermediate

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator

Chair

Bianca Zimon, LLM

Speaker

Panelist
Daniel Pereira

Panelist
Marcelo Moreira, MS

Panelist
Dandara Braga Santana, MHS

Component Type: Session
Level: Intermediate

This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Elena Popa, MPharm

Speaker

Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Component Type: Session
Level: Intermediate

Global key initiatives towards harmonization, convergence and collaborative efforts in advancing the development and accessibility of advanced therapy medicinal products (ATMPs) will be explored, with a special focus on supporting MICs.

Learning Objectives

Outline global efforts on collaboration and harmonization initiatives for ATMPs; Identify and discuss efforts to build regulatory capacity, provide technical assistance, and facilitate access to ATMPs in middle-income countries (MICs); Discuss strategies for achieving convergence and harmonization for ATMPs.

Chair

Maria Antonieta Tony Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Sarah Adam

Collaborative and Harmonization Initiatives Advancing the Development and Accessibility of Advanced Therapy Medicinal Products
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

ANVISA Perspective
Renata Miranda Parca, AHIP

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: 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.