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Levelling the Interaction Between Patients and European National Competent Authorities (NCAs) - Challenges & Possible Pitfalls
Session Chair(s)
David Haerry
Patient Advocate, EATG, Switzerland
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)
David Haerry
Patient Advocate, EATG, Switzerland
Presentation of Survey Results: Overview of the Survey Conducted by EUPATI Analysing the Current Level of NCA-Patient Interaction in Regulatory Procedures at NCAs
Lars Bo Nielsen, MSC
Director General, Danish Medicines Agency (DKMA), Denmark
Panelist
Sinead Curran
Director of Human Products Monitoring, HPRA, Ireland
Panelist
Richard Ballerand
Partner, AXOLOTL/HDRUK/NICE/NHSE/EUPATI/EITH/JPAC, United Kingdom
Panelist
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