Introduzione
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.
MODULE 1 – 24 November 2021 from 09:30 am to 12:30 pm CET
1. Current scenario: introduction to Real World Evidence
2. A practical taxonomy of observational research
3. RWE strategy and study designs
MODULE 2 – 26 November 2021 from 09:30 am to 12:30 pm CET
4. Statistics for RWE: sample size and bias
5. Methods for retrospective research
6. Best practices for publishing observational studies
MODULE 3 – 30 November 2021 from 09:30 am to 12:30 pm CET
7. Understanding propensity score and its uses in RWE generation
8. Lies, damned lies and… propensity score: controversies
9. Case studies
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.
Participants’ experience: some familiarity with biomedical research/drug development is recommended
Interactive training with practical approach and Q&A sessions
Docente/i
Stefano Viaggi
Statistician and Real World Evidence expert, with a passion for innovation and creativity. Senior consultant with 30+ years’ experience in the pharmaceutical and healthcare sector, providing statistical, scientific and strategic support to leading multinational companies and scientific organizations. Scientific facilitator and trained business coach following the international standards of ICF (International Coach Federation).
Online Training – 3 modules
MODULE 1 | 24 November 2021 from 09:30 am to 12:30 pm CET
MODULE 2 | 26 November 2021 from 09:30 am to 12:30 pm CET
MODULE 3 | 30 November 2021 from 09:30 am to 12:30 pm CET
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: € 1.080,00* (until 25 October 2021)
Ordinary: € 1.260,00*
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, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.