Finding ways to work closely with the European Medicine’s Agency (EMA) to learn how best to support our researchers in the regulatory strategy of their therapeutic development, remains a key focus of EATRIS. Through the ADVANCE Programme which aims to educate and train the next generation of ATMP developers, the EMA has worked closely with EATRIS to drive the regulatory aspect of our online course.
In addition to the collaboration on the ADVANCE online course which currently has over 500 registrations, on 29 November 2021, EATRIS, EMA and the ADVANCE Programme also co-hosted a webinar titled “Navigating the regulatory requirements for ATMPs”. This highly successful, and informative webinar was attended by over 300 participants, with scientists and regulatory experts represented from across academia, industry, and governmental organisations. You can rewatch the webinar below. This webinar aimed to introduce the ATMP research community to a new set of flowcharts and checklists that can help stakeholders navigate the regulatory requirements for ATMPs. These documents can now be found here under Guidance on the development of advanced therapy medicinal products – Flowcharts and checklists and we hope you find them useful in answering some of the key questions that your ATMP development presents.
ADVANCE Programme webinars, that educate the ATMP developers on the different challenges that these complex products face on their way to the patients that need them, will continue in 2022. For the updated schedule for ADVANCE 2022 events, keep an eye on ADVANCE LinkedIn and Twitter.