2024 ADB-CoRE Capacity Building Programme

ADB-CoRE Training Workshop: Indonesian Food and Drug Authority Regulatory Oversight for Advanced Therapy Medicinal Products (ATMP)

Period

11 - 14 November 2024

Project Details

Advanced therapies, covering the scope of cellular, tissue and gene treatment modalities, is a rapidly advancing field that offers exciting new life enhancing and saving therapeutic possibilities but constantly challenges the regulatory environment to expedite access to these new innovations. The field of advanced therapies is increasingly converging with biological products, and regulators who can understand the science and regulations of vaccines, biological products and advanced therapies will be able to enable innovations and support economic developments in these areas.

CoRE was delighted to conduct the 2nd ADB-CoRE training workshop in Jakarta from 11 to 14 November, on Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs). This workshop aims to provide a better understanding of the different frameworks and practices regulating advanced therapies, including requirements for product evaluation and dossier submission for an effective product life cycle management. The course will be productive for Indonesian Food and Drug Authority (BPOM) regulators to understand global trends in regulatory approaches and strengthen the skillsets to accommodate innovation. There is also a focus on promoting convergence of regulatory approaches for advanced therapies

This bespoke workshop, developed for the Indonesian Food and Drug Authority (BPOM), was made possible with the support of the Asian Development Bank and in collaboration with BPOM and global regulatory experts in this emerging field. Together, this workshop discussed the complex and nuanced regulatory decisions on regulating ATMPs in a risk-based and scientific approach to facilitate access to quality, safe and efficacious ATMP.

Click here to view the programme brochure