ADVANCED THERAPEUTICS WORKSHOP
13-15 January 2016
Amphitheatre, Level 2
Duke-NUS Medical School
The Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School held an “Advanced Therapeutics Workshop” from 13 – 15 January 2016, bringing together 93 speakers and participants from international and ASEAN regulatory authorities, government agencies, industry, academia, healthcare providers and research institutions.
The workshop provided a neutral academic forum for sharing and learning of experiences in the challenging area of regulating advanced therapeutic products, developing a better understanding of relevant regulatory requirements and systems in more advanced jurisdictions, and identifying opportunities for regulatory convergence in this field.
Participants found the workshop very helpful in gaining a better understanding of the scientific fundamentals of advanced therapeutics, the basis of existing regulatory frameworks, and experiences faced by different regulatory authorities.
The workshop concluded with an emphasis on early and continued engagement amongst multiple stakeholders as an important step to move forward and strengthen regulatory processes and frameworks, to enhance robustness, flexibility and alignment with the latest scientific perspectives in this field.
Leveraging on the knowledge and expertise of the international experts present at the workshop, a closed-door roundtable was held on the afternoon of 15 January to discuss and identify practical steps to enhance the regulation of advanced therapeutics in Asia. The roundtable participants, including regulators and industry representatives, contributed helpful advice and opinions on identifying priority areas and feasible actions towards capacity building in Asia through a more constructive platform for better collaboration between regulators and key stakeholders. The roundtable discussion and recommendations will be reported in a white paper later in 2016.