Message from EMA’s Outgoing Executive Director
Professor Guido Rasi’s last day as Executive Director of EMA comes in the middle of one of the biggest public health emergencies of the past century. “We are seeing an unprecedented effort…to tackle the pandemic. The number of therapeutics and vaccines that are currently under development is encouraging, and information on the initial results from clinical trials on vaccines is starting to be reported by the pharmaceutical industry. In the words of one developer, ‘we are a significant step closer’ to a vaccine.”
He emphasized the importance of the role that regulators would be playing in reviewing the available data packages. “EMA will ensure that the scientific review is conducted as rapidly as possible. This is a vitally important step as the time spent in conducting the review will not only ensure that our stringent regulatory standards are met but will also serve to reinforce public confidence in the vaccines.”
His successor, Emer Cooke, he describes as, “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the Agency’s work on COVID-19-related activities continues uninterrupted.” And that What is needed now is, “a reinforcement of EMA’s resources so that it can continue to deliver on its core business, deliver on the joint EMA/Heads of Medicines Agencies strategy…to address future challenges and undertake the additional activities to fulfil its new mandate.”
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
