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ONLINE TRAINING: Inside Real World Evidence
Filling data gaps: methodology, updates and insights in RWE and Observational Studies
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 provide methods and hints to successfully:
• identify and 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.
• understanding the methodology behind complex statistical methods used for RWE in published scientific papers.
1. Current scenario: introduction to Real World Evidence
2. A practical taxonomy of observational research
3. RWE strategy and study designs
4. Statistics for RWE: sample size and bias
5. Methods for retrospective research
6. Best practices for publishing observational studies
7. Understanding propensity score and its uses in RWE generation
8. Lies, damned lies and… propensity score: controversies
9. Case studies
Laureato in Scienze Statistiche all’Università di Padova, 30 anni di esperienza nella ricerca clinica sperimentale ed osservazionale, ha disegnato o partecipato a più di 200 progetti tra ricerca, comunicazione e formazione per aziende multinazionali del settore Life Science. Docente in master universitari e formatore aziendale su temi di Real-World Evidence, metodologia della ricerca e innovazione. Facilitatore di numerosi Advisory Board e gruppi di esperti. La sua passione è unire rigorosità metodologica e creatività risolutiva nell’ideazione di progetti innovativi e mobilitare persone e organizzazioni a cambiamenti sorprendenti.
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 willing to promote, design and manage Real World Evidence project to generate evidence and support the product value.
Interactive training with practical approach and Q&A sessions
This online training in divided in 3 modules:
- Module 1 | 16 October 2020 from 09.30 to 12.30 CEST
- Module 2 | 23 October 2020 from 09.30 to 12.30 CEST
- Module 3 | 30 October 2020 from 09.30 to 12.30 CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 1080,00* (until 2 October 2020)
Ordinary: € 1260,00*
Freelance - Academy - Public Administration: € 663,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuition, teaching materials and attendance certificate that will be sent after the training via e-mail.
Friday, October 2, 2020
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