On this episode, Dr. Anke-Peggy Holtorf joins us to help demystify the complex processes of regulatory affairs and health technology assessment (HTA) and explain the crucial role of patients in these processes. Anke acts as Secretary of the Board at Health Technology Assessment international  and is a Steering Committee member and project coordinator for the Patient and Citizen Involvement in HTA Interest Group. She is co-editor of the 2nd edition of the book on Patient Involvement in HTA, which will be published in 2025. Anke has also taught graduate courses in International Health Policy, HTA, and the role of patient involvement. Anke's global experience and depth of knowledge spanning decades shine through as she simplifies some highly technical and complex concepts for our listeners.  Chapters:0:00 - Introductions1:34 - Overview of regulatory affairs and HTA6:48 - The regulatory approval process12:09 - Patient involvement in regulatory affairs22:19 - Overcoming barriers to patient involvement27:32 - Regulatory success rates30:30 - The HTA process32:32 - Differences in healthcare models36:46 - Factors evaluated in HTA43:45 - Patient involvement in HTA54:32 - Advice for patients and stakeholders59:08 - Reflections with Caitlin and ClarindaResources and definitions:HTA - Health Technology Assessment Reimbursement: the process by which healthcare providers are compensated/paid back for the medical services they provide, either by the government or through insuranceOut-of-pocket costs: when patients pay for their own medical costsFDA - US Food and Drug AdministrationEMA - European Medicines AgencyChinese FDA QALY - Quality adjusted life yearsWHO - World Health OrganizationNICE - National Institute for Health and Care Excellence, UKCF Trust - Cystic Fibrosis Trust EUPATI - European Patients' Academy on Therapeutic Innovation EUCAPA - European Capacity Building for Patients Anke's report on Patient Involvement in HTA in Europe - full report and short versionHave feedback or suggestions for us? We'd love to hear from you!Website: notjustpatients.comLinkedIn: Not Just PatientsEmail: [email protected]

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