Introduzione

Evidence-based medicine (EBM) hierarchically organizes different sources of medical information with meta-analyses, systematic reviews, and randomised clinical trials (RCTs) which provide the strongest and most reliable evidence and patient registries which fall under observational studies classified as a source of low-level evidence.

RCTs, the golden standard of medical evidence, are meant to generate unbiased data for inferring causality from observed associations whereas the observational studies are often seen as delivering poor quality information. However, the reality is not always so clear and straightforward. The main concern related to RCTs as guidance in medical decision-making is their applicability to daily clinical practice and generalisability to a patient population at large.

Real-world data (RWD) refer to any observational data collected outside of clinical trials or clinical investigations. Patient registries, belonging to the  RWD family, are gaining in importance as a source of medical information. Therefore, it is critical to understand the specificity of such data and the way they should be interpreted.

This course focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings including patient registries and experimental trials, and their relevance in clinical context.  It will additionally provide tools for critical appraisal of the published registry data.

 Module 1 – Principles of RWD and RWE

  • Definitions
  • Sources
  • Utilization
  • Stakeholders
  • Basics of medical research: clinical trials vs. observational studies

Module 2 – Patient registries 

  • Definition and basic principles of patient registries
  • Purposes
  • Types of registries
  • Current uses
  • Critical appraisal of published patient registry data
  • Exercise

This course addresses individuals from pharmaceutical and medical device companies primarily medical affairs, clinical, operations, medical science, R&D, market access and pharmacovigilance. Additionally, it will be beneficial for national health service decision-makers, payers, clinicians, medical doctors, health care professionals, and anyone who is interested in real-world utilization of health care services.

 Participant experience

Participants should have general understanding of drug development and clinical research relating to medical interventions. No specific experience required.

The course will consist of lectures, discussions and hands-on exercises.

Docente/i
Maria Koltowska-Häggström
Info

Maria Koltowska-Häggström

MD, PhD, CMO at Proper Medical Writing
After completing her medical studies in Wrocław, Poland, Maria worked for ten years as a paediatrician. In 1991, she began working within the pharmaceutical industry where she gained experience in both the marketing and medical sides of the business. Between 2001 and 2013, Maria worked at Pharmacia (later Pfizer) in Stockholm, Sweden, where she held various responsibilities for large patient registries. She was a leading member of numerous research groups investigating growth hormone disorders in paediatric and adult patients managed in the real-life clinical setting. She has an extensive track record of patient registry research and  lectured at multiple meetings related to patient registries, late-phase drug development, data management, drug safety evaluation, and QoL research. She earned PhD at Uppsala University, Sweden, based on patient registry studies of QoL in adult patients with growth hormone deficiency. She is a vice-president of the European Medical Writers Association (EMWA), and a member of European Association of Scientific Editors (EASE), European Society of Endocrinology (ESE), and Growth Hormone Research Society (GRS). Additionally, as a long-time EMWA member, Maria is a trainer and a workshop leader, section editor for Medical Writing, and a chair of the Expert Seminar Series Organizing Committee.

This online training is divided in 2 modules:

Module 1 | 19 April 2023 from 09:00 am to 01:00 pm CEST
Module 2 | 21 April 2023 from 09:00 am to 01:00 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: € 880,00* (until 29 March 2023)

Ordinary: € 1.070,00*

Freelance – Academy – Public Administration**: € 570,00*

*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.

Acquista
Early bird
Acquistabile fino al 29/03/2023
880,00
Ordinaria
Acquistabile fino al 18/04/2023
1.070,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 18/04/2023
570,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the principles of real-world data (RWD), real-world evidence (RWE) and patient registries
Risultato atteso
Identify pros and cons of RWE
Risultato atteso
Select the most appropriate registry design for your needs
Risultato atteso
Design a patient registry as a part of late-phase drug development
Risultato atteso
Interpret published results generated from different patient registries

<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>