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|Mondher Toumi MD, PhD
Professor of Public Health University of Marseille
Creativ-Ceutical,a MEDiSTRAVA company
VP HEOR and Market Access, Associate researcher at the University of Marseille
Creativ-Ceutical, a MEDiSTRAVA company
Despite having obtained a Marketing Authorization and addressing medical needs, medicines may fail to be reimbursed or access the market as expected. Therefore it is essential to have a clear identification of the evidence gaps from the various perspective (regulatory, clinical and payers/HTA) and to develop an actionable evidence generation plan that will fill these gaps. Traditionally every function (medical, regulatory, commercial, and market access) develop their plan for their specific activities, but there is a needs to have a global plan for optimal evidence generation that addresses all the stakeholder's needs.
This webinar will help the learner, in the context of complex disease, to:
1) Understand the regulatory, clinical and payers archetypes and their respective needs and how to tailor the evidence to these archetypes
2) Guidance on how to collect and elicit the internal and external stakeholder feedback on the different evidence gaps (clinical, regulatory, economic, humanistic )and recommendations for evidence generation
3) Learn the key types of Real World Evidence studies and how they can address different stakeholder needs
4) Ensure that the Evidence generation plan and deliverables serve both the purpose of informing and guiding the medical community and also supporting Price & Reimbursement negotiations
5) Guidance on how to collect and elicit the internal and external stakeholder feedback and recommendations for evidence generation
6) How to develop an actionable evidence generation plan that addresses the needs of all stakeholders
In this webinar, the facilitator of the will categorise the stakeholders into different categories (Regulatory, Clinical, Payers) and different archetypes and define their specific needs for complex disease.
In particular, the Professor of Market Access will reflect on basic design types of real-world evidence studies with a focus on complex disease, and prompt feedback from the audience on other examples of studies that could be part of the evidence generation plan and present and discuss examples in the complex disease area.
Finally using a hypothetical product in a complex disease, the Professor of Market Access and VP of HEOR will provide guidance on how to develop an actionable evidence generation plan that addresses the needs of all stakeholders.
|To register for this Webinar, click here.|