This session will feature a presentation from Heraclio Rodriguez, Sanofi, on Cooperation Agreements, Memorandums of Understanding, and Letters of Intents as instruments to facilitate the implementation of reliance in Latin America

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For over a decade, the medicines regulatory landscape in Africa is undergoing a transformation under the AMRH initiative.

During the years, several national regulatory systems showed significant progress with at least 4 countries obtaining the (WHO) Maturity Level 3.

Progressing towards common continental regulatory standards will form the bedrock of future reliance, though some degree of regulatory convergence exists under the various Regional Regulatory Harmonization Initiatives there are issues with implementation in practice.

Progress in capacity development is realized through the implementation of medical regulatory harmonization initiatives in regional economic communities, as well as through the Regional Centers of Regulatory Excellence.

Establishment of the AMA is perceived as a highlight of all these activities and is foreseen to contribute to the overall efforts in ensuring faster access to medicines, vaccines, and diagnostics, and achieving a broader overview of all regulatory activities in the continent.

In the early days of the new agency establishment, it is important to reflect on all the learnings along the way, but also to connect with similar efforts from other regions and utilize all experiences to set the right foundation and consistently and diligently build on it.

It is important to reflect on the expectations from stakeholders related to AMA deliverables, consider how the success will be measured and what mechanisms should be established to allow for adjustments needed along the way.

This session aims to connect AMRH partners and key stakeholders with the relevant EU partners with relevant experience while establishing EMA.

It will offer a platform to discuss the learnings, challenges and opportunities for establishment of efficient, functional, modern continental agency as the AMA, which will not only ensure efficient and fit-for-purpose regulatory institutions are established, and ready to adequately address challenges, but also contribute to the overall improvements of the healthcare systems and ultimately health of African patients.

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This session will feature a presentation from Stephan Roenninger, Amgen, on The Innovation Landscape and Opportunities Facilitated By ICH Quality Guidance

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This session will feature a presentation from Stephan Roenninger, Amgen, on ‘Risk-based efficiency’ of inspections: Not just a buzzword but a real opportunity after the pandemic

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This session will feature a presentation from Jeffrey Scott, Pfizer, on Industry Perspectives on Data Ethics and Trust

More information about the session here.