Introduzione

Real-world data (RWD) is an extraordinary resource that is increasingly available to provide useful information to guide development of a new product, to understand characteristics of the diseases, to identify needs of caregivers and patients, and to assess the clinical value of a health technology or medical procedure under 'real-world' conditions. Increasingly, RWD are being used to support regulatory or health economic decisions.

In this context, observational clinical research methods are the main tool for collecting RWD and generating Real World Evidence (RWE). However, due to their complexity, the variety of study designs and the lack of clear regulations, observational clinical studies often lead to lower than expected results or encounter serious difficulties in their regular conduct, with increased costs and time.

The aim of this course is to provide the basic knowledge needed to conduct RWE using observational clinical methods. Therefore, there will be ample time devoted to topics such as:

  • the observational method and its main study designs
  • what to expect and what not to expect from a real world study
  • when and why to use the observational method in pre- and post-marketing product development, using a multidisciplinary approach
  • the main sources of real world in the digital health era
  • what regulations impact on real world and how to address the challenges they pose
  • How to organise and conduct an observational clinical study.

Module 1
The observational method
Aims and study designs
Prospective and retrospective studies

Module 2
The value of RWD
Main types of studies (PASS, PAES, registries, etc.)
Hybrid studies

Module 3
Regulatory framework
Off-label studies and studies with additional diagnostic procedures
How to set up observational clinical research

 

The course is highly recommended for curious people who want to explore the fascinating and complex world of observational clinical research in a methodical and systematic way, and especially for professionals already working or starting to work in the functions of Medical Affairs, Market Access, Drug Development/Clinical Research, Real World Evidence Generation of Life Sciences companies who are faced for the first time with the need to design and/or conduct projects to generate RWE evidence on their own products and on specific healthcare processes or technologies.

Participant experience: Familiarity with biomedical research/drug development is recommended but not required.

Highly interactive training. Discussion of real cases.

Docente/i
Giovanni Fiori
Info

Giovanni Fiori

RWE Advise & Projects

He holds a PhD in the Biology of Human Populations and a master’s in public health. Since 1994 he has conducted epidemiological research as part of international cooperation programs in Central Asia led by the University of Bologna. In 2003 he was the founder, president (until August 2018) and scientific director (until March 2022) of Medineos (formerly MediData Studi e Ricerche) where, in addition to developing the business, he was responsible for defining the strategy for designing and conducting more than 150 local and international Real World multi-centre observational studies for the pharmaceutical industry and non-profit organisations. Together with French, German, Czech and Spanish colleagues, he was one of the founders of the European observational research network WellCRO. From 2018 to 2022, following the entry of Medineos into the IQVIA group, he also held the position of Senior Principal Observational Study in the Italian branch. Since 2005 he has been the coordinator of the “Observational Studies and Real-World Evidence” Working Group of the Italian Society of Pharmaceutical Medicine (SiMeF, ex SSFA), where he was also a board member of directors. At the European level, he was responsible for the “Late Phase” working group of the European CRO Federation (EUCROF). He regularly teaches the Master of Clinical Research at the Bicocca University of Milan. Invited as a speaker at various congresses & conferences, he is the author or co-author of over a hundred articles and scientific communications.

This online training is divided in 3 modules:

Module 1 | 17 October 2023 from 09:00 am to 12:00 pm CEST
Module 2 | 19 October 2023 from 09:00 am to 12:00 pm CEST
Module 3 | 24 October 2023 from 09:00 am to 12:00 pm CEST

Some days before the online training 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: € 945,00* (until 26 September 2023)

Ordinary: € 1.155,00* 

Freelance – Academy – Public Administration: € 615,00* 

* 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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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
correctly define what RWD is and what is meant by clinical research using observational methods
Risultato atteso
understand the usefulness and limitations of RWD to generate RWE, and how to capture its value both pre- and post-marketing
Risultato atteso
set up a RWD collection, taking into account the regulatory aspects and organizational constraints associated with observational clinical research
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Generating Real World Evidence (RWE) with Observational Methods