What have global regulators learned from the pandemic?
At #DIA2022 Global Annual Meeting this week, I have had the opportunity to chair two sessions dedicated to the International Coalition of Medicines Regulatory Authorities, or ICMRA.
Session 1 focused on the COVID-19 response and international collaboration.
Session 2 highlighted how to best use the COVID-19 learnings for the future.
ICMRA has had a critical role in harmonising the response of global regulators to the pandemic. It has helped to align our different approaches and the?regulatory flexibilities for the development and approval of urgently needed vaccines and therapeutics against COVID-19.
If ICMRA hadn’t existed, we would have had to invent it.
We are committed to further expand and strengthen cooperation between global regulators and look at new ways of working together even beyond crisis situations. With COVID-19 we learned that no single agency – no matter how big or well-resourced – can ‘go it alone’.?
Some proposed ways of demonstrating collaboration are reliance on hybrid inspections and joint assessments in the area of manufacturing and product quality, where specific pilots are underway. We will also explore new approaches to clinical trials for public health emergencies, look?to expand real-world evidence networks and tools, as well as how best to use artificial intelligence in medicines regulation and safety.
During the pandemic we have shown that we can do things differently and that we can be innovative. There is no going back.
Partner, Life Sciences KPMG: Former Biotech, Pharmaceutical, Med Tech and Devices Commercial Leader and Marketer with global, EMEA and Local market experiences. Contact [email protected] for further information.
2 年There is no doubt that ICMRA played a fulcrum role in supporting more rapid solution finding during the COViD 19 pandemic. Lessons learned will have enduring value. Evaluating the relevance of emergency response tactics in the context of everyday medicine needs careful consideration. It’s all about the knowledge balance of risks and benefits in the context of the appropriate timeframe. Delighted that this is still being critically reviewed with pilots emerging.
Tendering Engineer
2 年With COVID-19 we learned to give in our ears that curious kid - no matter how small or under - resourced – can ‘make a difference and permutatively save life'.?