To kick off the iDR25 conference series, two exclusive pre-conference workshops will be held on 6th May 2025 at the Royal Netherlands Academy of Arts and Sciences (KNAW). The workshops are primarily aimed at academics, early career researchers and patient representatives looking to increase the understanding of key topics related to medicines repurposing and gain practical skills to apply to current and future drug repurposing projects.

Register today for the pre-iDR25 workshop series!

Workshop 1: Health Technology Assessment: a key tool to patient access

Tuesday 6th May 2025

12:30-14:30

After regulatory approval by the EMA, Health Technology Assessment (HTA) becomes a pivotal process in determining whether new treatments will be accessible to patients, influencing their affordability, availability, and overall impact on healthcare systems. The HTA dossier encapsulates critical information, including the medical, economic, social, and ethical considerations of using a health technology—such as a repurposed medicine. Prepared by the product developer or sponsor, these dossiers undergo evaluation by HTA agencies, like EUnetHTA 21 in the EU or NICE in the UK, to assess their value and feasibility.

This workshop will equip researchers, patient representatives and product developers with the knowledge and tools to design their repurposing projects to meet HTA standards from the onset. With a focus on early alignment with HTA requirements, evidence planning, and incorporating patient engagement into the HTA process from the beginning, attendees will gain actionable insights to streamline their projects through HTA evaluations, enhancing the likelihood of timely patient access.

This workshop offers a unique opportunity to learn proactive strategies to maximise the success of drug repurposing projects in achieving their ultimate goal—reaching and benefiting patients.

Workshop 2: Navigating the regulatory path for medicinal product repurposing

Tuesday 6th May 2025

15:00-17:00

In this workshop, we will discuss the regulatory path and key milestones for advancing a repurposed/repositioned medicinal product from preclinical development to market authorisation in Europe, tailored for academic researchers and early-career developers navigating such processes for the first time. Whether you are preparing for your first clinical trial application or strategising for market authorisation, this session will provide crucial tools and insights to help build your regulatory strategy including:

• Core elements of a Clinical Trial Application (CTA)
• Obtaining Orphan Drug Designations for rare diseases
• Effective engagement with regulatory authorities (e.g. scientific advice)
• Overview of possible registration pathways to bring promising therapies to patients faster
• Building the Common Technical Document (CTD) for a European Marketing Authorisation Application (MAA)

Register today for the pre-iDR25 workshop series!

Note: this event is separate to the main conference. Find out more about iDR25: Medicines Reimagined here.

Questions? Contact conference@remedi4all.org.