This self-paced online course will give an understanding of current techniques, opportunities and challenges for the use of real-world evidence (RWE) in medicine development. This is an ideal course for anyone who wishes to become familiar with key issues in the area of real-world data (RWD) and wishes to broaden his/her expertise.
Course participants will come from pharmaceutical companies, regulatory authorities, health technology assessment bodies, patients’ organizations, consultancy companies and academia. The course will foster discussion, interaction and mutual learning across all professionals involved in medicine development.
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Course participants will come from pharmaceutical companies, regulatory authorities, health techonology assessment bodies, patients’ organisations, consultancy companies and academia. The course will foster discussion, interaction and mutual learning across all professionals involved in medicine development.
The course consists of self-paced Learning Units, addressing different aspects of RWE. The five Learning Unit’s require approximately 20-25 hours of input. Please note that this course is designed for those with some familiarity with the development process for medicines. The course aims to give an overview of various concepts, approaches and techniques in real-world evidence generation. It is not designed to provide detailed training on specific methods (analytical techniques and study designs).
Course Learning Units will cover the following topics:
There are two editions of the Real-World Evidence in Medicine Development course in April and October 2023.
At the end of the course, you will be able to:
Self-paced online learning via the platform of Elevate Health
This self-paced online course is available through Elevate Health’s Virtual Learning Environment. Participants will be guided by an e-moderator from Elevate, who will assist with any questions about online learning and the Virtual Learning Environment.
Participants will learn through web lectures, case studies as well as individual assignments and self-tests. Participants will have the opportunity to connect with a key expert from the GetReal Academy for questions on the content and assignments in the course.
The course can be started at any time and will need to be completed within 6 months. The average workload for the course is 20-25 hours per week. 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 and choose which form of guidance works best for you.
Interaction with an international peer group: you will be able to learn, communicate and share knowledge with fellow students from all over the world.
Professional e-moderation: during your online learning journey, you will be guided by a professional moderator from Elevate Health.
This course consists of individual assignments such as web-lectures, self-tests, as well as reading assignments and stimulating questions.
Pieter Stolk, PhD
Pieter Stolk has been part of the project management team in IMI GetReal from the start in 2013, and was part of the team developing the Online RWEMD course. He has a background as a pharmacist, and has a PhD from the Division of Pharmacoepidemiology and Clinical Pharmacology at Utrecht University. He considers himself as a ‘generalist’, with a focus on topics around regulatory/HTA/policy issues around medicines development.
Mira Zuidgeest, PhD
Mira Zuidgeest works as an assistant professor at the University Medical Center Utrecht (UMCU) and also part-time at the science driven clinical research organization Julius Clinical, the Netherlands. She is a pharmacist by training with a master in epidemiology and a PhD in pharmacoepidemiology. She has a strong background in observational research, experience as health care provider in hospital pharmacy and a special interest in pediatric asthma, which led her to do a post-doc in Brazil.
Her current work at the Julius Center focuses mainly on the topic of pragmatic trials and how to translate the concept of pragmatic trials to a methodologically sound and operationally feasible trial. As such, she is the scientific lead for the task force on pragmatic trials of the IMI GetReal Initiative. Combining the methodological work at the UMCU with the practice of clinical trial conduct at Julius Clinical provides her with a direct link between theory and practice.
Noemi Hummel, PhD
Noemi has a background in biomathematics and statistics, with a great interest in modelling. Her experience in the biomedical field comes from both academia and industry. She works as a Senior Scientific Manager in a company consulting pharmaceutical companies and HTA. She holds a master in mathematics and a PhD in economics.
Mike Chambers, MSc
Mike Chambers is Director of MC Healthcare Evaluation, which he set up in 2016 to provide advice on the generation of evidence of value of health technologies for healthcare payers. Until 2015 he was head of Value Demonstration and Reimbursement in Market Access at GSK, where he advised on emerging evidence requirements for reimbursement and local access to medicines, and developed innovative methods for communicating the value of GSK’s medicines to healthcare decision makers. He was previously Director of Health Economics in GSK R&D, where he led the respiratory therapy area health outcomes team. From 2001 to 2006 he established a health economics function (for diagnostic imaging) at Amersham Health/GE Healthcare. Mike has degrees in mathematical philosophy, demography and health economics and has also worked in the UK NHS, University of London, and HEOR consulting.
There are no set deadlines in this course but the course needs to be completed within 6 months.
Participants will receive a certificate upon timely and successful completion of all assignments.
• Participants distributed over the whole medicine development chain: from academic researchers and patients’ organisations to industry, regulatory and HTA professionals.
• No diplomas are required for enrollment, but the course is aimed at participants with some familiarity with biomedical research/medicines development.
• 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, 8-10 hours should be allocated to the course each week. This level of intensity will make the course of most value to participants.
• Standard fee: €1200
• 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.
• To enroll, please select a date and click on the red ‘enroll’ button on this page. You will be directed to our online enrollment system. After successful application, you will receive an email confirming your enrollment.
• Are you experiencing problems when enrolling? Please check whether you have filled out all required fields (all that are marked with *). If you need any help with your enrollment or have any questions, please don’t hesitate to contact us at email@example.com or +31 (0)85 488 5380.
• In the online enrollment system we offer a couple of payments options: you can pay by Visa or MasterCard, or if you live in the Netherlands, by using iDEAL. You can also arrange for payment by your employer via an invoice. After you have enrolled, you will receive a confirmation email including the invoice. If you choose to pay via invoice, you will receive an invoice (PDF file) by email once your application has been approved. Please forward the invoice to your employer. Please pay as soon as possible before the course starts.
• International wire transfers may take up to two or three weeks to process internally. After this period, please contact us at firstname.lastname@example.org to enquire about the status of your payment should the status of your application still mention ‘not paid’ while you already transferred the money. Please include a proof of the payment so that we can track your payment.
• In case of cancellation by the participant: all cancellations must be received in writing. You may cancel/transfer your enrollment in a course:
– Without administrative charge: at least 30 days prior to the starting date of the Course.
– With payment of an administrative charge of €125 if the cancellation is between 10-30 days before the course will start.
– No refunds are given in cases enrollment will be cancelled 10 days before, on, or after, the date on which the course starts.
• Occasionally, due to various circumstances, Elevate may change course schedules or locations or cancel a course without specifying the reasons thereof. If Elevate cancels the course in which you have enrolled and if Elevate is not able to reschedule you into another course that suits your needs, Elevate will refund the costs you have paid for the relevant course and will in no event have any further liability to you with regard to the cancelled course.
• In case of cancellation by Elevate: You will be informed personally before the course would have started. You can then either enroll in another online medical course at that time, or we can reimburse your fee.
We believe that future-proof research is essential for good care. That is why we combine innovative medical knowledge with didactics. Thanks to our extensive network and proven didactic methods, we make Life Sciences and Health professionals better than yesterday.
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