EURORDIS website
⌛️ 5h45m
EURORDIS Open Academy School on Medicines Research & Development
The EURORDIS Open Academy School on Medicines Research & Development is made up of one week of face-to-face training, held in June in Barcelona, and the free e-learning modules below, available on demand.
The EURORDIS Open Academy School on Medicines Research & Development aims to provide rare disease patient advocates with the knowledge and skills needed to become experts in medicines research and development. Since 2015, researchers are also welcome to attend the School.
Over 20 experts, from across all rare disease stakeholders, deliver the training each year. The topics covered include clinical trials methodology, clinical research, ethics in medicines development, regulatory affairs, health technology assessment and marketing authorisation.
Download the Open Academy School on Medicines Research & Development flyer
Take part in free online training
Learn more about medicines research and development at a time and place that suits you! Take the free e-learning courses below.
The conditions of use for all EURORDIS e-learning courses have been licensed with Creative Commons. More information on the conditions of use.
Before you start, you may want to download the following Glossary document, which covers key terms that you will find in the different courses below:
[▼] Glossary on Methodology, Ethics, Statistics, Pharmacology and Regulation
We also advise you to download this compilation elaborated by the European Medicines Agency (EMA) containing plain-language descriptions of medical terms commonly used in information about medicines:
[▼] EMA Medical Terms Simplifier
Free
Medical Research and Development
Free
Ethics in clinical trials
⌛️ 2h
Free
Fundamentals of statistics in clinical trials
⌛️ 3h
Free
Benefit-risk assessment and pharmacovigilance
⌛️ 2h 45m
Free
The European Medicines Agency (EMA)
⌛️ 4h45
Free
Medical Regulatory Framework and Procedures
⌛️ 2h30m
Free
Market access & Health Technology Assessment
⌛️ 1h30
Support Materials for the EURORDIS Open Academy School on Medicines Research & Development
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E-learning courses
Free
Recommendations on the required capabilities for patient engagement
⌛️ 2h
Free
Conflict of interest in patient engagement
⌛️ 2h
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Other resources
IRDiRC’s Orphan Drug Development Guidebook
The “Orphan Drug Development Guidebook” is a patient-focused guidebook that describes the available tools, incentives, resources and practices for developing traditional and innovative drugs/therapies for rare diseases and how to best use them. It can be used by academic, non-profit organizations, small and larger (innovative) biotechs and patient-driven drug developers.
READ MORE
Community Advisory Boards
Community Advisory Board (CAB) refers to a group of patients who offer their expertise to sponsors of clinical research and who advise several sponsors in their field. CABs are autonomous bodies, not related to the sponsor or chosen by them.
READ MORE
Engaging with the European Medicines Agency
The European Medicines Agency (EMA) plays a crucial role in the regulation and oversight of medicines within the European Union (EU). Recognizing the importance of patient involvement, the EMA actively seeks to engage patients throughout the regulatory lifecycle of medicines. By involving patients, the EMA aims to gather valuable insights, promote patient-centric decision-making, and enhance the overall safety and effectiveness of medicines. Open this page to read the various activities in which patients can engage and how they can actively participate in shaping the regulatory landscape.
READ MORE
About the EURORDIS Open Academy School on Medicines Research & Development
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Alumni
To date, more than 400 participants from over 40 countries representing more than 75 diseases have participated in the EURORDIS Open Academy School on Medicines Research & Development.
Thanks to capacity-building provided by EURORDIS, alumni members have gone on to become involved in various activities at the European Medicines Agency (EMA), such as Protocol Assistance, and to participate in activities related to the European Network for Health Technology Assessment (EUnetHTA).
Open Academy School on Medicines Research & Development alumni report an increased awareness of the importance of their involvement in all aspects of medicines development and of their potential to be a real force at the European and national levels.
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History of the School
The first School was launched in 2008 and was originally developed to fill specific needs identified by expert patients, EURORDIS and the European Medicines Agency.
Expert patients from EURORDIS are permanent representatives on EMA Scientific Committees and working parties, for example, the Committee for Orphan Medicinal Products, the Patients’ and Consumers’ Working Party and the Scientific Advice Working Party.
EURORDIS, therefore, created the Open Academy School on Medicines Research & Development (formerly Summer School) in recognition of patients’ needs for support and training that includes an overview of clinical research and methodology, medicines development and regulatory procedures.
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Financial support
The EURORDIS Open Academy School on Medicines Research & Development receives funding under an operating grant from the European Union’s Health Programme (2014-2020) and under the European Union’s Horizon 2020 Research and Innovation Programme, notably under the European Joint Programme on Rare Diseases.