Alessandra Oortwijn
Global Head of Evidence Generation Alfasigma Spa
Dr. Alessandra Nunes Faria Oortwijn is a seasoned medical affairs leader and the current Global Head of Evidence Generation at Alfasigma S.p.a. With over a decade of clinical and academic experience and more than 20 years in the pharmaceutical industry, she brings a wealth of expertise across clinical development, scientific communication, medical education, launch excellence, KOL engagement and real-world evidence (RWE) research. Her work spans multiple therapeutic areas, with a strong focus on internal medicine, particularly endocrinology and immunology. Dr. Oortwijn is recognized for her strategic vision and commitment to advancing evidence-based healthcare on a global scale.
Seminars
With EHDS moving from regulation towards implementation, the challenge for RWE teams is shifting from understanding what the legislation means to preparing for how data will actually be accessed, reused and governed across Europe. This interactive workshop will put attendees in the role of RWE strategists, working through realistic data access scenarios to navigate different national requirements, data holders, contracting models and ethical considerations. By the end of the session, attendees will have practical frameworks to assess data-access routes, anticipate country-level barriers and build more efficient strategies for future RWE programmes.
This workshop will gather experts to discuss:
- Work through real-world data access scenarios involving registries, hospitals, academic institutions and patient organisations to identify potential bottlenecks before studies begin and build a practical framework for assessing data-access routes across European countries, including regulatory, ethics, contractual and commercial considerations.
- Develop strategies for negotiating with diverse data holders and establishing clearer expectations around access, payment, data use and timelines.
- Identify the internal processes, partnerships and infrastructure RWE teams should start building now to be operationally ready as EHDS implementation progresses.
