Introduzione
It is a today common opinion that the vast potential of Real-World Data (RWD) is a valuable resource not only for disease understanding but also for product development, health technology assessment and market access.
In this context is very much important to understand the pivotal role of research methods in collecting Real World Evidence (RWE) to support regulatory decisions and /or to allow a strategic use of clinical RWD.
This 2-step intensive course will allow you to learn how to setup a methodologically sound RWD collection able to generate RWE, focusing on several critical success factors: methodological, regulatory and operational.
Gain insights into navigating the digital health era, understanding regulations that impact real-world research, and effectively organising and conducting data collections.
Step 1 of this course empowers you with essential knowledge, covering topics like methodological and technical aspects of real-world studies, different study designs and applications and how to manage the complexity of a very heterogenous regulatory environment.
Step 2 explores the concept of "study-project dualism" in real-world research, where study and project objectives may not align entirely. Grasp the strategic design phase's importance in overcoming organizational and cultural barriers, involving various stakeholders from clinical R&D, marketing, market access, and more.
A remote homework, between step 1 and 2, will allow you to consolidate the notions and concepts learned by applying them to a real case taken from your company context, which you can then use to deepen the advanced design techniques that will be exposed in the second part of the course, learning from a well-established methodology, honed through the successful design of numerous observational studies, how to align study and project objectives seamlessly.
PROGRAM STEP 1: METHODS, VALUE AND REGULATIONS
MODULE 1 | DEFINITION AND METHODS
- Methodological characteristics of RWD collections
- Types of data collections (aims versus study designs)
- Primary data and secondary use of existing data; the “hybrid studies”
MODULE 2 | THE VALUE OF RWE
- The value of RWD: an historical overview. Current and future impact of RWD on life sciences product development
- Limits of the observational methods in generating RWE
MODULE 3 | REGULATIONS AND GUIDELINES
- International regulatory framework
- Ethical and administrative authorization processes
- Special cases: off-label drugs and EAP; additional diagnostic procedures; registries; hybrid studies;
PROGRAMM STEP 2: STRATEGIES FOR RWE GENERATION
MODULE 4 | THE PROJECT DESIGN
- Methodological introduction to “project” (the strategy) and “study” (the tool) design
- The strategic use of RWD in the pre- and post-marketing phases
- Case studies and exercises
MODULE 5 | DEVELOPMENT OF A CONCEPT SHEET
- From the strategy to the study: how to combine business with ethical and scientific objectives in clinical research
- The executive design phases: from study scenarios to the concept sheet
- Case studies and exercises
Step 1 is highly recommended for curious people who want to systematically explore the fascinating and complex methodologies of RWD use in the context of clinical research, and especially for professionals already working or starting to work in Medical Affairs, Market Access, Regulatory, Drug Development/Clinical Research, Real World Evidence Generation functions of Life Sciences companies.
Step 2 is recommended for those in decision-making and coordinating roles in Medical Affairs, Clinical Research, Real World Evidence Generation who must generate pre- and post-marketing Real World Evidences to support corporate product development and define strategies to market access.
Participant’s experience
Step 1: Familiarity with clinical research is useful.
Step 2: Familiarity with the topics covered in Step 1
Highly interactive training and discussion of real cases.
Docente/i
Giovanni Fiori
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.
Online Training – 5 modules
STEP 1
Module 1 | 08 May 2024 from 9:30 am to 12:30 pm CEST
Module 2 | 15 May 2024 from 9:30 am to 12:30 pm CEST
Module 3 | 22 May 2024 from 9:30 am to 12:30 pm CEST
STEP 2
Module 4 | 10 October 2024 from 9:30 am to 12:30 pm CEST
Module 5 | 17 October 2024 from 9:30 am to 12:30 pm 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.
STEP 1
Early Bird: € 945,00* (until 17 April 2024)
Ordinary: € 1.155,00*
Freelance – Individual – Academy – Public Administration**: € 615,00*
STEP 1+2 (whole course)
Early Bird: € 1.450,00* (until 17 April 2024)
Ordinary: € 1.790,00*
Freelance – Individual – Academy – Public Administration**: € 930,00*
STEP 2
Early Bird: € 650,00* (until 19 September 2024)
Ordinary: € 850,00*
Freelance – Individual – Academy – Public Administration**: € 490,00
To register for step 2, you need to have the basic knowledge needed to conduct RWE using observational clinical methods, such as the observational method and its main study designs, what to expect and what not to expect from a real-world study, how regulations affect real-world studies and how to address the challenges they pose, and how to organise and conduct an observational clinical study
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – 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.
Mara Claudia Algarotti
Training Manager & MW Operations
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.
