As efforts on the African continent are concentrated on accelerating the operationalization of the African Medicines Agency (AMA), it is important to consider and leverage the experience and learnings from mature regulatory agencies such as EMA and international work-sharing schemes like WHO CRP, EUM4All, Swissmedic MAGHP, and ACCESS Consortium.

As a new, modern regulatory agency, AMA has the potential to establish a robust and unique regulatory framework to address gaps and inconsistencies in national regulatory systems as well as optimize technical capabilities, regulatory expertise, and digital tools to drive efficient and sustainable regulatory operations at the continental level.

Great strides have been made in enhancing regulatory harmonization and convergence in Africa via the Africa Medicines Regulatory Harmonization initiative and its partnership platform, and the Regional Economic Communities’ (RECs) implementation of several joint assessment procedures (JAPs) (e.g., EAC, ZAZIBONA, and ECOWAS).

The need to strengthen harmonization of other parts of the registration is also imperative. To further enhance collaboration and work-sharing, AMA must consider lessons learned from the various regional JAPs and international regulatory work-sharing procedures. Given the positive impact of digitalization, digital tools can also drive efficiencies in the AMA’s operations, benefitting all stakeholders in the regulatory ecosystem, especially patients.

This session will highlight regional and international experiences from JAPs, and how these can uplift the Africa regulatory ecosystem, including by advancing maturity of several national regulatory agencies and RECs in Africa. The session will also cover the adoption of digitization initiatives on the continent and offer a platform for engagement and dialogue on optimizing operationalization of the AMA.

More information about the session here.

This session will focus on the current status of reliance and recognition between European and other global regulators. The speakers will cover flagship topics of high interest to industry, including ICMRA pilot programs, the experience of industry innovators in developing a global vaccines reliance pilot, and reflections on the status of reliance and recognition in GMP.

Regulators and industry will offer reflections and proposals for how the future state can increasingly use reliance and recognition to enable more harmonized and streamlined approaches to assessment of the CMC dossier and assurance of GMP, with the ultimate goal of enabling more accelerated and secure supply of medicines to patients.

Stephan Roenninger, Amgen, will present on behalf of IFPMA on the future of inspection frameworks.

More information about the session here.

This session will focus on the global regulatory frameworks for enabling innovation in manufacturing and quality. Innovation includes the development and manufacture of new types of products, new manufacturing platforms, innovative technologies such as model-based controls, the wider scope of and new analytical technologies.

The implementation of new digital tools and manufacturing technologies are key to the evolution of manufacturing, which can be enabled by tools such platform technology master files. The session will reflect on how groups such as the new EMA Quality Innovation Group is seeking to lead the transformation of medicines’ manufacturing in Europe and how this is linked to fast moving initiatives outside of Europe, such as FDA FRAME and platform design technology programs, ICH, and ICMRA collaborative initiatives under the PQKMS umbrella, including collaborative assessments. The discussion will also focus on how collaboration and the identification of risk can already enable technology.

Gert Thurau, Roche, will bring a perspective on the use of artificial intelligence in manufacturing on behalf of IFPMA.

More information about the session here.