The European Medicines Agency (EMA) has developed a three-year plan to formalize, structure and develop interactions with the academic community.
The European Medicines Agency (EMA) has developed a three-year plan to formalize, structure and develop interactions with the academic community.
“Academia plays an important role in helping the EU medicines regulatory network keep abreast of the opportunities and challenges brought by science, be it in the context of the development, assessment or safety monitoring of medicines,” noted EMA’s Executive Director Guido Rasi in a statement. “The framework will allow us to integrate cutting-edge scientific knowledge more tightly into our activities. It will also help academic start-ups benefit from advice from the EU regulatory network to translate their discoveries into patient-focused medicines.”
The framework’s objectives are to:
The framework builds on EMA’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals and the pharmaceutical industry, continued the statement. The agency has also published a new web page for academia providing links to content that is likely to be of interest, and a section describing the way EMA interacts with academia, with more detail on the collaboration framework and action plan and useful resources for academics.
According to Prof. Piet H. van der Graaf, of the Leiden Academic Centre for Drug Research (LACDR) in The Netherlands, “This is an important step towards a strong alignment of the European excellence in regulatory and academic pharmaceutical sciences. In my discipline of systems pharmacology, I expect that this will act as a catalyst for new and better collaborations and cross-fertilisation in research, training and education. This should ultimately have a positive impact on the development of novel personalized medicines for patients.”
The dialogue between EMA and academia has already improved in time, but this is the perfect moment to structure this interaction and bring it to the next level, commented Dr. Rosa Giuliani, EU Policy Committee, European Society for Medical Oncology (ESMO).
“The framework of collaboration is a timely initiative, which is expected to fulfil specific tasks,” she said. “This is the platform needed to 1) promote regulatory awareness, 2) support academic research and 3) boost communication between the two parties. Now it is time to work!”
To view the full release, click herePhilip Ward is the European Editor for Applied Clinical Trials
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.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.