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Levelling the Interaction Between Patients and European National Competent Authorities (NCAs) - Challenges & Possible Pitfalls
Session Chair(s)
David Haerry
Co-Chair Advisory Committee
EUPATI Foundation,European AIDS Treatment Group, Belgium
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department
European Medicines Agency, Netherlands
Today, the EMA and some National Competent Authorities (NCAs) increasingly involve patients in their work. Specifically, EMA engages in the provision of information and support for the patient community and in-house capacity building for its staff. Patient organisations, and others, like the European Patients’ Academy on Therapeutic Innovation (EUPATI), also provide training for all stakeholders on the regulatory processes and possible roads to collaboration. This session provides a closer look at the current level and framework of NCA patient involvement in their regulatory procedures based on a survey run in 2023 by EUPATI with the support of the Heads of Medicines Agencies (HMA). Survey results and surfacing gaps and obstacles for NCA-patient collaboration will be presented as well as emerging needs for capacity building for the patient community and in-house staff and possible solutions will be discussed in a roundtable.
Learning Objective : Expand the discussion on patient involvement in regulatory procedures in NCAs. Obtain a high-level overview of the present NCA regulators’ interaction with patients/patient organisations. Identify needs and gaps and identify opportunities for improvement of capacity building for patients as well as for NCA staff.
Speaker(s)
Presentation of Survey Results: Overview of the Survey Conducted by EUPATI Analysing the Current Level of NCA-Patient Interaction in Regulatory Procedures at NCAs
David Haerry
EUPATI Foundation,European AIDS Treatment Group, Belgium
Co-Chair Advisory Committee
Panelist
Lars Bo Nielsen, MSc
Danish Medicines Agency (DKMA), Denmark
Director General
Panelist
Sinead Curran
HPRA, Ireland
Director of Human Products Monitoring
Panelist
Richard Ballerand
AXOLOTL/NICE/NHSE/UKABIF/EUPATI, United Kingdom
Patient Advocate/Expert Advisor
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