IFPMA at DIA Global 2025

15 - 19 June 2025 Washington, DC
Date

15 - 19 June 2025

Hosts

DIA Global

Location

Washington, DC

Attendance

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IFPMA will be at DIA Global 2025. The conference is a key platform for sharing industry experience and engaging with global regulatory authorities, healthcare professionals, and experts to shape the future of regulatory science.

IFPMA and member experts are involved in several session at DIA Global, leveraging industry expertise on topics ranging from regulatory reliance, leveraging global standards to strengthen the drug supply chain, PQKMS and the evolving regulatory landscape in Africa.

Join us as we engage in critical discussions shaping the future of regulatory frameworks.

See below which sessions will feature contributions on behalf of IFPMA, and consult the full programme here.

Program

16 June 2025, 11:00 am - 12:00 pm EDT Putting Patients First: Leveraging Global IDMP Standards to Strengthen the Drug Supply Chain and Improve Lives

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

 

17 June 2025, 10:30 am - 11:30 am EDT Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project.

Learning Objectives

Describe the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.

17 June 2025, 16:00 - 17:00 pm EST Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

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.

18 June 2025, 08:30 - 09:30 am EDT How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance

This session will highlight the complexity of regulatory frameworks for PACs drawing from an IFPMA/Clarivate study and case studies. An expert panel from industry and regulatory agencies will discuss solutions and lessons learned on reliance implementation.

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Identify lessions learned from reliance implementation for PACs to facilitate supply of medicinal products.

18 June 2025, 13:45 - 14:45 pm EST Africa's Evolving Regulatory Landscape

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.

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