EPEMED is a central point of communication and coordinated actions that accelerates broader adoption of personalised medicine and advanced diagnostics, and access to these treatments by patients across Europe by

  • Recommending optimal regulatory and reimbursement routes to delivering personalised medicines to patients efficiently
  • Promoting improved development of personalised medicine through the creation and application of advanced diagnostic tests
  • Designing and developing education and training programs to help stakeholders better understand the needs and challenges around personalised medicine

Personalised medicine has introduced a new mode of thinking with major impacts on all organizations positioned in the field of healthcare. Among these organizations, regulatory agencies are keys stakeholders providing the frame and rules to manage patient-related risks. The regulatory context impact directly on market access conditions for the diagnostic industry in terms of constraints (cost, time) but also for value recognition (e.g. LDT vs approved tests) and innovation for the patients (performance evaluation, availability of new assays). This context is subject to major evolution in the coming years. The EPEMED Regulatory Committee ambition is to impact on the future IVD regulatory landscape for the benefit of patients, industry and translational research.

The regulatory committee of EPEMED focuses on the followings:

  • Gather EPEMED members position on current and future regulatory context, formulate a consensus positioning that can be communicated/publicized to PM stakeholders
  • Convey to EU regulatory agencies / EMA / SANCO the EPEMED positioning on new guidance and regulation (Directive 98/79/EC, EMA guidance on PGx)
  • Participate and intervene in major events /meetings comprising regulatory discussions to make sure the voice of EPEMED is transmitted
  • Interact with major trade association (EDMA, BIVDA, EFPIA, Europabio,…) to articulate and leverage EPEMED actions
  • Interact with National regulatory bodies to influence decision making process at the European and National levels


Chair: Karen S. Long,
DVP, Medical, Regulatory, and Clinical Affairs, Abbott Molecular Inc
and EPEMED Member
Vice Chair: Patrick Larcier,
Pharm.D., MBA, Senior Director,
Head of the Personalized Medicine Group, Voisin Consulting Life Sciences
and EPEMED Member