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A number of regulatory convergence efforts are underway globally, including efforts from the Asia-Pacific Economic Cooperation (APEC). The overarching goal of these convergence efforts are to ensure that global standards for drug approvals are being applied consistently across agencies. In an effort to ensure convergence, APEC has implemented a Center of Excellence training model. This model will ensure convergence through fostering international collaborations between agencies and ensuring harmonized standards are applied, which will bring products to market faster and cheaper. APEC has identified Cell and Tissue Based therapies as an up and coming area for convergence. In order to ensure regulatory convergence, there must be convergence in training and capacity building, thus APEC is working closely with other organizations including the International Conference for Harmonization (ICH).

Ability Level: All

Session ID: 21075