Hurry! Less than two weeks remaining to apply for a free 2024 ‘Portfolio and Technology’ meeting with the European Medicines Agency
As part of its efforts to foster research and the uptake of innovation in the development of medicines, the European Medicines Agency (EMA) have recently offered free-of-charge ‘Portfolio and Technology’ meetings within 2024 to pharmaceutical companies with large medicinal product portfolios. Now, with less than two weeks to go before applications close, companies are advised to submit their 2024 meeting request without delay.
The virtual meetings are intended to allow companies to discuss the issues impacting the progress of their medicinal products, to capture new and disruptive technology already in use, and to anticipate the scientific and regulatory expertise needed to assess any future applications.
To be considered for a meeting, interested pharmaceutical companies must submit an online meeting request to the EMA via a dedicated application form, before 10 November 2023.
The application form requires companies to provide details of the product(s) to be discussed, their stage of development, mode of action and the therapeutic area concerned, as well as the enabling tools and technology employed in their development. Up to eight topics may be proposed for discussion, with the form inviting applicants to consider the focus areas identified in the EMA’s Regulatory Science Strategy to 2025. These include innovation within nonclinical models and clinical trials, as well as application of digital technology, artificial intelligence, big data and real world data within the scope of the current regulatory frameworks. Topics also include the integration of science and technology in medicines’ development, such as:
- Precision medicines
- Translation of advanced therapy medicinal products into patient treatments
- Innovative medical devices and borderline products
- New materials in pharmaceuticals and novel manufacturing technologies.
Prior to submission, any agency-specific queries regarding the planned meetings or meeting request form can be directed to the EMA’s Business Pipeline address (email@example.com). Following submission of the meeting request, companies can expect the EMA to advise on the appropriate next steps by the end of 2023. Applicants can request the quarter within 2024 in which they would prefer to meet with the EMA.
If you have any questions on this topic or want to reach out regarding any aspect of your own Regulatory programme, please don’t hesitate to get in touch. You can contact us via email (firstname.lastname@example.org), or by telephone (S-cubed Ltd: +44 1235 77 22 60).
How can S-cubed help you?
Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds, and therapies for orphan indications. We know that regulatory advice is crucial to your product’s success and as our client, we will ensure that you receive the best and most up to date advice and hands-on expertise. Why not get in touch to see how we can help?
Source: Innovation in medicines – Portfolio and technology meetings