Real-world evidence should be incorporated throughout all the product’s lifecycle to ensure a significant value during its launch and commercialization. An integrated patient-centric perspective among different stakeholders and a focus on continuous evidence generation is the way forward for the life science industry.
This course will be mainly focused on providing methods to successfully:
- Identify & prioritize the different RWE needs throughout the product lifecycle.
- Apply the observational approach to evaluate “unmet needs” during the clinical development as well as the impact of the drug utilization in the real-world (i.e. patient’s perceptions, effectiveness, safety and benefit in diverse environments and specific patients subset).
- Adopt a multidisciplinary approach to design optimized RWE projects that combine multiple stakeholders needs (i.e. Medical Affairs, Market Access and Clinical Development) to generate clinical evidence aligned with the product strategy and its lifecycle stage.
Who should attend?
The course is for professionals working in Medical Affairs, Market Access, Drug Development/Clinical Research, Real World Evidence generation, HEOR of pharmaceutical and biotech companies.
Some familiarity with biomedical research/drug development is recommended.
The course programme will focus on the following topics:
- RWD and RWE: current strategic context
- Methods for RWE generation
- Study designs
- RWE to support the value of the product over the whole lifecycle
- Potential RWE use cases
- Workshop and discussion
Focused lessons, discussions and workshops.
At the end of the training, you will be able to:
- Plan RWD projects able to support the value proposition of your product during the whole lifecycle.
- Adopt a tested multi-step technique to design your RWD project, based on the Company’s strategy and multi-stakeholders’ need leading the entire product development and commercialization.
Simona Sgarbi, Senior Real World Evidence Lead – Lundbeck
Simona holds a MS in Biophysics. Since 2002 (when she joined Medineos-an IQVIA company), she has been working in Real World Evidence research focusing on methodology and laws/regulations within the pharmaceutical and medical device fields. This has involved the project management of complex multinational peri- and post-approval studies. She is highly skilled in connecting the product development strategy with the design of observational studies (including prospective and retrospective cohort studies, case control, cross sectional) and various typology (such as epidemiological studies, patient registries, PASS/PAES, MCR, etc.). She has authored several scientific publications in peer-reviewed scientific journals and presented lectures for both national and international congresses. She is an active member of international scientific associations, including ISPOR (International Society of Pharmaco-economics and Outcomes Research). Recently, she has joined Lundbeck as Senior RWE Lead within the HEOR & RWE Medical Affairs Department, based in Copenhagen.