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WEBINAR: Real-World Data and Real-World Evidence
An intensive Webinar to learn the main concepts behind Real-World Evidence and Observational Research and to design innovative studies that generate evidence
Nowadays Real-World Data (RWD) are an essential tool to develop and show the value of new health technologies through the observation of what happens in a real clinical setting. Real-World Evidence (RWE) gives us an excellent opportunity to better understand diseases, patients’ needs and improve health processes. The promise of RWE is that a rich diversity of data collected from extremely large patient samples will produce more precise, targeted and more effective healthcare treatments on an individual patient level. The methodology to generate RWE can very much differ from one study to the other, since one may use different study designs and data sources. However, all RWE projects, with the sole exception of pragmatic trials, have the scientific methodology in common with observational studies. For this reason, a solid knowledge of the principles of observational research, and of its distinctive characteristics as compared to interventional clinical trials, will provide participants with a sound methodological background to approach RWE projects. During this 2-days course, we will address methodological and contextual aspects of observational research, insights on specific types of projects and on the impact of new technologies in the field. Observational research is only partially regulated - both locally and internationally - so a basic knowledge of some ethical and regulatory constraints is also required in order to properly design RWE studies. The experience and perspective of a relevant Ethics Committee will help participants to consolidate their knowledge to appropriately design and conduct observational research. The quality of the evidence produced by observational research will also be analysed based on the perspectives of the different guidelines and tools that are used to study evidence from the perspective of the payer and of companies willing to liaise with payers.
REAL-WORLD EVIDENCE RESEARCH METHODOLOGY
- The context of Real-World Evidence
- Real-World Evidence and Observational Research
- Project and study design in Observational Research
- Sample size and Bias
- Retrospective Observational Research
- Overview of the different types of RWE projects
- From Real-World Data to artificial intelligence: what Machine Learning can offer
REGULATIONS GOVERNING OBSERVATIONAL RESEARCH
- Regulations and data privacy in observational research
- The Ethics Committee perspective: practical experiences
- Advertising and promotion of observational research
- Guidelines to evaluate scientific evidence
Workgroup: interactive exercise of Design Thinking
She has a Bahcelor’s degree in Statistical Sciences at the University of Padua. She has worked in the pharmaceutical industry taking part in the drafting of research projects and in the analysis of results. She has also worked at The Italian National Institute of Statistics (ISTAT) as a researcher for the 2000 Census and finally at the University of Padua where she has been an associate professor since 2015.
She has co-authored over 150 scientific articles mainly in the cardiology, hepatology and paediatric fields. She has been a member of the Clinical Research Ethics Committee of Padua since 2005, which she has chaired since the end of 2013. Finally, since 2010 she has been a member of the Ethics Committee for Animal Experimentation of the University.
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.
To all those who work in the Life Science field within pharmaceutical, medical device or biotech companies and find themselves in the need to promote, design or conduct Real-World Evidence projects to generate evidence and support the value of their products. To professionals operating in the fields of medical affairs, clinical research, market access, RWE and / or in all areas involved in the strategic planning of innovative data-driven projects to generate scientific evidence.
This Webinar in divided in 4 modules:
- Module 1 | 6 May 2020 from 11.00 to 13.00
- Module 2 | 8 May 2020 from 11.00 to 13.00
- Module 3 | 12 May 2020 from 11.00 to 13.00
- Module 4 | 14 May 2020 from 11.00 to 13.00
The fee includes
Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
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: € 890,00* (until 29 April 2020)
Ordinary: € 965,00*
Freelance - Academy - Public Administration: € 534,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Wednesday, April 29, 2020
At the end of the training, you will be able to
Know which are the keys for the successful design of a Real-World Evidence project
Liaise with in-house and external stakeholders on Real-World Evidence
Identify the appropriate methodologies to design and conduct Real-World Evidence innovative projects