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Day 1

9th RWE, Market Access, Pricing & Reimbursement Global Congress 2023 Europe

Day 1 - Thursday 4th - May 2023


  • Trends that will continue to impact, Market Access, Pricing and Reimbursement in healthcare
  • Unlocking data from early access
  • Effective communications with internal and external stakeholders
  • Embracing the digital vision
  • Future trends and developments in the healthcare distribution


 Dr. Marco Rauland, Vice President, Global Value Demonstration, Market Access & Pricing, Merck KGaA


Libby Hamson, Senior Manager, Market Access, Pfizer
Senior Representative, OPTiMAX Access

  • Current trends in parallel advice: What has changed?
  • Importance of seeking early regulatory, HTA, and joint consultation
  • Risk and advantages of using parallel consultation at the EU or national level?
  • Successful strategies to maximise the benefit of parallel consultation
  • Overview and key aspects
  • Status and timeline
  • EU joint HTA and national submissions
  • Challenges and implications

 Elvira Müller, Vice President, Evidence & Access, CERTARA

  • Impact of the Life Science Strategy Sector Deal
  • NHS 10 Year Plan
  • Future of the UK Government/Industry Voluntary Scheme for Branded medicines.

 Santoke Naal, Director Market Access, IGES U.K. Pharma Ltd

  • When and how to integrate value planning into development
  • Staying responsive to changing market conditions Trends to watch
  • Enabling diverse perspectives through timely engagement

 Esther  Nzenza, Founder and CEO, Decisive Consulting Ltd.

  • Historical use, and impact, of value-based pricing in multi-indication drugs and combination drugs
  • Lessons to be learnt from historical VBP cases
  • Potential avenues to improve on value-based pricing of ‘special’ drug categories
  • Examples of how health systems are adapting their pricing mechanisms

 Mitun Patel, Director, Red Nucleus

 Higia Vassoler, Associate Director, Red Nucleus


  • Plasma-derived medicines (PDMPs) are essential for some 300,000 patients across the EU who rely on these therapies every day to treat a variety of rare, chronic, and life threatening conditions. Without these treatments, many patients would have a substantially diminished quality of life, and some may not survive.
  • PDMPs are a finite resource because the manufacture of these medicines is dependent on the amounts of human plasma collected.
  • Using the AIFA CTS Innovation Algorithm and the WHO Framework for Appropriate Medical Use, a broad range of Key Opinion leaders, in the field of immunology, neurology, rheumatology and dermatology, debated about the appropriate use of Immunoglobulins for their patients. The discussion
    was concluded in a Green Paper developed by Vintura.

 Maarten Van Baelen, Executive Director, Plasma Protein Therapeutics Association

  • Robust RWE generation to accelerate drug approval and inform clinical practice during a rapidly
    evolving pandemic
  • COVID-19 and the wide-ranging role of RWE in informing decision making: From disease monitoring to
    treatment effectiveness
  • Methodological considerations and cautionary tales of RWE generation in COVID-19
  • Best practices and lessons learned for effectively utilizing RWD/RWE in future pandemics

 Stephane Read, Sr Technical Consultant, Epidemiology, Certara Evidence & Access

  • Recognize the potential of Personalized Medicine in Oncology / Cancer Patients benefits;
  • Identify challenges which could be encountered during HTA process;
  • Develop strategies to overcome or to remove any barrier for Patient Access to Precision Oncology
  • Cost to Society, Health System and Government
  • Technology and Evidence Development

 Rafael Souza, Head, Access Solutions & Pricing, New Markets, BeiGene Switzerland

  • The use of RWD early in the process to boost trial diversity and inclusion
  • Challenge in setting diversity goals early in clinical trial planning
  • Development of a diversity plan to ensure adequate representation of racial and ethnic subgroups in clinical trials
  • Utilizing RWE in the post-marketing setting to complement clinical trial findings and support post marketing requirements or commitments for safety and efficacy data in a diverse patient population

 Riad Dirani, VP of Global HEOR, Medical Operations & Excellence, Teva

  • Regulatory challenges following Brexit and its effect
  • Steps taken by MHRA to alleviate the effects of leaving the European regulatory network.
  • Understanding the current state of pharmaceutical sector
  • Addressing the priorities for negotiations
  • The ability of UK citizens to access new medications


 Matthias Heck, Sr Director, International TA Policy Strategy, Alexion Pharmaceuticals


 Santoke Naal, Director Market Access, IGES U.K. Pharma Ltd

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