This self-paced online course gives an understanding of current techniques, opportunities and challenges for the creation of real-world data (RWD) to generate and use real-world evidence (RWE) for medicines in development.
Course participants come from pharmaceutical companies, regulatory authorities, health technology assessment bodies, patients’ organisations, consultancy companies and academia.
The course consists of five self-paced chapters, addressing different aspects of RWD and RWE, and requires approximately 10-12 hours of input. This non-technical course is designed for those with some familiarity with medicines development and wish to broaden their expertise of this topic.
Course Learning Units will cover the following topics:
This is an ideal course for anyone who wishes to become familiar with the various concepts, approaches and techniques of involved in generating and using RWD and RWE.
At the end of the course, you will be able to:
Self-paced online learning
This self-paced online course is available through Elevate Academy.
Participants will learn through expert video’s, blogs, interviews and individual assignments. Participants will have the opportunity to learn from key experts in the field.
The course can be started at any time and will need to be completed within 12 months. The average workload for the course is 10-12 hours in total. Participants will be able to study at their own pace and convenience and are not required to attend the course at specific times.
Advantages of an online course
Flexibility and efficiency: there is no need to travel to attend a lecture, so you can spend your time very efficiently.
Personalized learning: you can study at your own pace.
Prof. Dr. Rick Grobbee
Rick Grobbee is Professor of Clinical Epidemiology at University Medical Center Utrecht, and Distinguished University Professor International Health Sciences and Global Health at Utrecht University. He is director of the MSc and PhD training programmes in Epidemiology, Chair of Julius Global Health and Chief Scientific Officer and Director of Julius Clinical Ltd. Rick is also the founder of the Elevate online academic education platform in Life Sciences and an active researcher on cardiovascular and cardiometabolic diseases.
Prof. Dr. Wim Goettsch
Wim Goettsch is professor and chair for Health Technology Assessment (HTA) of Pharmaceuticals at the University of Utrecht. He is currently Special Advisor HTA at the Dutch National Health Care Institute (ZIN). From 2016-2021 he was director of the EU HTA Network (EUnetHTA) Joint Action 3 and from 2016-2018 he was chair of the EUnetHTA Executive Board. He is currently leading the EU Horizon 2020 consortium HTx (Next Generation Health Technology Assessment).
Mike Chambers, MSc
Mike Chambers is Director of MC Healthcare Evaluation, which he founded in 2016 to provide advice on generating evidence of value in health technologies for healthcare payers, and he currently provides consultancy services to a variety of pharma companies and specialist research organisations. He contributes to a range of projects under the EU Innovative Medicines Initiative (a public-private partnership), where he was a founding member of the IMI GetReal project, and he is also a member of the Technology Appraisal Committee at UK NICE.
Dr. Mira Zuidgeest
Mira Zuidgeest (PhD, PharmD) is an Associate Professor at the University Medical Center Utrecht in the Netherlands. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and operational. She is a board member of the GetReal Institute (www.getreal-institute.org) and led the development of a decision-support tool for randomised clinical trials integrated into routine clinical practice (www.getrealtrialtool.eu). As academic lead for the IMI Trials@Home project (www.trialsathome.com), she researches possibilities of centring trials around patients rather than clinical sites through the use of innovative technologies (Decentralised Clinical Trials).
Dr. Helga Gardarsdottir
Dr. Helga Gardarsdottir is associate professor at the Division of Pharmacoepidemiology & Clinical Pharmacology (Utrecht University, NL). Her primary research interests include the application and development of innovative approaches to generating and analysing real world data on the safety and effectiveness of medicines to inform regulatory and clinical decision making. Her special research interest is on assessing the impact of drug regulation on safe and effective use in populations. Dr Gardarsdottir was trained as a pharmacist and a pharmacoepidemiologist.
Dr. Noemi Hummel
Noemi Hummel is an Associate Director at Certara, a global consulting company in the pharmaceutical industry, with a focus on tech-enabled services and biosimulation. She holds a PhD in economics from the Swiss Federal Institute of Technology Zurich, and a master’s degree in applied mathematics from the University of Heidelberg. She has 10+ years of experience in working as a project lead in the area of statistical and health economic modelling.
Prof. Dr. Hans Hillege
Hans Hillege is member for the Netherlands of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), which is the committee that grants marketing authorisation in the EU for new medicines in specific indications.
Dr. Stephen Duffield
Stephen Duffield is Associate Director for real-world evidence methods at NICE, where he is responsible in particular for developing, communicating and implementing NICE’s real world evidence framework, which is used to guide those submitting and evaluating RWE in support of new medicines seeking reimbursement.
• Course participants come from pharmaceutical companies, regulatory authorities, health technology assessment bodies,
patients’ organisations, consultancy companies and academia.
• No diplomas are required for enrollment.
• The course will be taught in English. To successfully participate, sufficient proficiency in reading and writing English is required.
• Sufficient time should be available. Based on prior experience with the course and feedback from participants, 10-12 hours should be allocated to the course in total.
• Standard fee: €800
• Public sector: government, university and non-profit organizations: €600
• Members of the GetReal Institute: 25% discount
• Groups: 10% discount for the enrollment of 4 participants (non-GetReal members only)
Please contact us at firstname.lastname@example.org to request a discount code for the public sector fee (€600) and/or a member of the GetReal Institute or group 10% discount code.