B10 - Research: From marketing authorisation to patient use and beyond

Carron

Organised by the FIP Social and Administrative Pharmacy Section in collaboration with the FIP Community Pharmacy Section, the FIP Hospital Pharmacy Section and the FIP Industrial Pharmacy Section

Chairs

Katja Hakkarainen (StatFinn & EPID Research, Sweden) and John Hertig (Purdue College of Pharmacy, Purdue University, USA)

Introduction

After a medicine has obtained a marketing authorisation, a great body of research on optimising health outcomes is conducted. Such research includes real-world evidence studies by marketing authorisation holders (pharmaceutical industry), for example, health economic evaluations, post-authorisation safety, and comparative effectiveness studies. In addition, outcomes of therapies, pharmaceutical services, and quality and safety in healthcare are studied by entities other than the pharmaceutical industry, for example, by health authorities, insurers, healthcare organisations (such as hospitals), often in collaboration with academia. Research after marketing authorisation may be conducted to meet regulatory demands, to inform decisions on reimbursement for the medicine, to optimise patient outcomes and to improve the delivery of high-quality and value healthcare across settings.

Even though research after marketing authorisation in different settings shares the same goal of optimising patient outcomes and improving the quality and value of healthcare, the real-world evidence studies by pharmaceutical industry and by other entities are commonly conducted separately, with little collaboration. This session will provide an overview of the variety of research being conducted after marketing authorisation, and discuss new collaborative research models with the goal of further optimising patient outcomes as well as improving the quality and value of healthcare.

Programme

14:30 – 14:35 Introduction by the chairs

  1. 14:35 – 15:50  Overview of research from marketing authorisation to patient use and beyond in varying settings
    1. 14:35 -14:50 Reasons for the pharmaceutical industry to promote real-life evidence
      Katja Hakkarainen (StatFinn & EPID Research, Sweden)
    2. 14:50 – 15:10 Research for optimising medication outcomes and improving the quality and value of medicines use in hospitals
      Jannet Carmichael (Pharm Consult NV LLC, USA)
    3. 15:10 – 15:30 Community pharmacy perspective on research for optimising patient outcomes and improving the quality and value of healthcare
      Luís Lourenço (Farmacia Central, Portugal)
    4. 15:30 – 15:50 The role of academia and professional organisations in research, from marketing authorisation to patient use and beyond in varying settings
      Timothy Chen (Faculty of Pharmacy, The University of Sydney, Australia)15:50 – 16:10 Coffee/tea break
  2. 16:10 – 17:20 Workshop – Bridging research from marketing authorisation to patient use and beyond in a variety of settings
    Discussion on new collaborative research models optimising patient outcomes and improving the quality and value of healthcare

17:20 – 17:30 Conclusion by the chairs

Learning Objectives

At the end of this session, participants will be able to:

  1. Outline research on real-world evidence conducted by pharmaceutical industry;
  2. Describe research for optimising patient outcomes and improving the quality and value healthcare in hospital and community pharmacy settings;
    3. Describe the role of academia and professional organisations in research from marketing authorisation to patient use and beyond;
    4. Identify new collaborative research models after marketing authorisation for optimising patient outcomes and improving the quality and value of healthcare across settings.

Type of session: Knowledge-based


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