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HTA Townhall – Ready for 2025 EU Joint Clinical Assessment
Session Chair(s)
Representative Invited
European Medicines Agency
Niklas Hedberg, MPharm
HTACG Co-Chair & Chief Pharmacist
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
The EU HTA Regulation will change the HTA decision making landscape in EU and preparation is in full speed by all stakeholders. This session will address this and other hot topics in the HTA arena. As the EU HTA Joint Clinical Assessment (JCA) will parallel the review process by Regulators, time for preparation of both dossiers, review, decision making and alignment with subsequent national reimbursement processes will provide new challenges for industry, HTA bodies and Regulatory Agencies. Patients and Physicians expect that access in innovation will be facilitated. This session will outline the challenges from various stakeholder perspectives and provide a vision on how all can best interact during the procedure while keeping the remit of the various assessment bodies. As an outcome we expect recommendations - what gaps still need to be closed on our way to full implementation. Several implementing acts are still in drafting stage.
Learning Objective : This session will provide an overview on the challenges for applicants, Regulators and HTAs in implementing the HTA regulation into practice. It will explain how companies can prepare themselves. It will predict how all stakeholders can best interact during the procedure.
Speaker(s)
Panelist
Paul De Boissieu
HAS, France
Scientific Project Manager
Panelist
Niklas Hedberg, MPharm
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTACG Co-Chair & Chief Pharmacist
Panelist
Valentina Strammiello, MA
European Patients' Forum, Belgium
Director of Programmes
Panelist
Isabelle Stoeckert, PharmD, PMP
Bayer, Germany
VP. Head Regulatory Affairs Europe Middle East Africa,
Panelist
Maya Matthews
European Commission , Belgium
Head of Unit State of Health, European Semester, Health Technology Assessment
Panelist
Inka Heikkinen, MBA, MS, MSc
Lundbeck, Denmark
Regulatory Policy Lead
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