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47665 - Plenary Session 3 - Global Submissions and Regulatory Assessments: Towards Harmonized Approaches in the Regulation of Medicines to Patients

‐ Jan 24, 2023 5:15pm

The COVID-19 pandemic demonstrated that international collaboration among global regulatory authorities and with industry is essential, achievable and enables the best use of available resources and expertise. Regulators and industry collaborated to expedite product development and decision-making processes to enable treatment availability at an unprecedented pace, scale, and geographical reach.
What are our lessons learned? How can we leverage the experiences gained during the pandemic to streamline development, harmonize systems, and drive faster approvals to deliver quality medicines to more patients faster not only in preparation for the next pandemic but also as a new way of working?
This regulatory panel will bring together regulators from several global regions for an interactive discussion about evolving practices and initiatives to support agency-agency, agency-industry and industry-industry collaborations, including:
- Discussions on the role of regional and international harmonization and regulatory convergence initiatives, including a wider implementation of international guidelines e.g., ICH, WHO, and their updates to address advances in pharmaceutical science, technology, analytics, data management, and regulatory concepts
- Share experiences from collaborative reviews, e.g., ICMRA pilots, project Orbis/Access Consortium and other collaborative pathways, discuss traditional and alternative approaches to inspectional assessment, and outline next steps to foster the use of reliance pathways
- Explore how we can accelerate regulatory harmonization not only for initial marketing authorizations but also for post-approval changes to achieve the blue-sky vision “One dossier, one submission, one inspection, one approval”, e.g., ICH M4Q revision, CMC dossier content alignment, ICH Q12 benefits.

Session Panelists:

Samvel Azatyan, World Health Organization

Christopher Downey, CDER, FDA

Veronica Jekerle, European Medicines Agency

Ingrid Markovic, CBER, FDA

Elkiane Rama, ANVISA, Brazil

Dean Smith, Health Canada

Eric Karikari-Boateng, Food and Drugs Authority, Ghana

Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency, Japan

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