c4c – External Training Courses Catalogue

This webinar series will cover topics from the basics, providing an introduction to how this new technology can modify diseases, though to a more in-depth look into operational aspects of delivering advanced therapies within the hospital environment. The sessions are delivered as a collaboration between London Advanced Therapies and the ATTC network.

To provide an understanding of advanced therapies and how they are delivered within the hospital environment.

The training programme consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision.

To prepare and train users in the use of the Clinical Trials Information System (CTIS).

This webinar is designed to introduce the concept of the the FAIR cookbook. The FAIR cookbook is a collection of ‘recipes’ designed to assist both academia and industry to apply FAIR data principles, which could help to build capacity for high quality data management. The FAIR cookbook was developed by FAIR Plus, which is an IMI (Innovative Medicines Initiative) funded project.

1. Learn how to improve FAIRness of data with exemplar datasets
2. Understand the levels and indicators of FAIRness
3. Discover open source technologies, tools and services
4. Find out the required skills
5. Acknowledge the challenges in FAIRification.

1. Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials.
2. Use of Real-World Data/Registries in Paediatric Drug Development.
3. Paediatric-only medicines development/First in child companies

This course from the EJP RD offers an exploration of key questions around rare disease diagnostic research and issues today, as well as insights into patient experiences.

You will discover more about the progress made through diagnostic research, as well as the types of genetic tests available for rare diseases, and the impact of having a diagnosis – or lacking a diagnosis – on patients’ lives. You’ll explore key issues relating to rare genetic diseases and undertake your own internet-based investigation into several diagnostic research topics.

The French Foundation for Rare Diseases is delighted to announce the upcoming opening of a new facilitation window of the MOOC From Lab to Clinic: Translational Research for Rare Diseases on October 9^th. This update will be available until December 2nd 2023.

With expert guidance, explore drug discovery, clinical trials, regulatory approval, and challenges in this unique field. Gain insights from patients and experts, understand trial planning, design, and data sharing. By the end, you’ll have a comprehensive understanding of how evidence is built for safe and effective treatments.

On this course you will explore the drug development process from the unique perspective of rare diseases, follow the journey from discovery to approved products, learn how therapeutic targets and drug candidates are identified and validated, examine the special regulatory frameworks, examine current research projects, and learn the definitions and contexts, as well as hearing from patients directly involved in clinical research.

You will explore some of the specific challenges of the drug development process, gaining contextual insights into this vital area of medical research.

On this five-week course from the European Joint Programme on Rare Diseases, students will explore the therapeutic development process from the unique perspective of rare diseases.

Students will follow the journey from discovery to approved treatment, learn how therapeutic targets and drug candidates are identified and validated, and examine the special regulatory frameworks.

During this course you will learn:

About each stage of a clinical trial, learning to plan and design a trial and address any regulatory issues.

To examine how to end a clinical trial and how to approach marketing approval and authorisation. Students will also investigate data sharing and reuse post-trial.

By the end of this course, students will understand how, during the process of translational research, you can build evidence that a treatment is safe and effective.

EpiCARE, in collaboration with ILAE Academy, have developed 6 patient-centred interactive e-learning modules, corresponding to diagnosis and management of some rare and complex epilepsies. Some of the modules include paediatric patient cases.

To support the diagnosis and management of some rare and complex epilepsies.

Educational webinars on rare neurological, neuromuscular and movement disorders jointly organized by the European Reference Networks for Rare Neurological Diseases (ERN-RND) and Neuromuscular Diseases (ERN-EuroNMD) and the European Academy of Neurology (EAN).

• Standardization, bias and data quality – focus on trustworthy, clinically relevant AI. 
• Regulatory framework.
• Use case MDS overview of results (both from a technical and clinical perspective) + specific onboarding requirements (e.g. minimal dataset) 
• Use case SCD overview of results (both from a technical and clinical perspective) + specific onboarding requirements (e.g. minimal dataset). 

• Use case MM overview of results (both from a technical and clinical perspective) + specific onboarding requirements (e.g. minimal dataset).

The course aims to provide healthcare professionals and caregivers with the knowledge and skills needed for managing a critically ill child during the first hour of illness, and preventing progression to cardiac arrest. Emphasis is also given to team management and non-technical skills.

• Recognition of a critically ill child
• Knowledge and skills in assessing and treating problems with the airway, breathing and circulation (including bag-mask ventilation)
• Intraosseous infusion Management of shock Scenario-based training in the management of critically ill children
• Basic life support treatment of choking
• Neonatal life support
• Advanced cardiac arrest algorithms Shockable and non-shockable rhythms, defibrillation Scenario-based training in the management of (imminent) cardiac arrest, severe trauma and special circumstances; with emphasis on non-technical skills and team approach Post-resuscitation care and ethics

This webinar aims to explore real cases and best practices for delivering a rare disease diagnosis
effectively, presented by experts from European Reference Networks (ERNs) such as ERN CRANIO,
ERN-EYE, and VASCERN. Following these presentations, a panel of specialists from various fields will
engage in a discussion to highlight identify best practice on how to deliver a diagnosis and ensure
individuals and their caregivers, families can access the psychosocial support they need.

Take this course to learn more about the three main EU institutions: the European Commission, the European Parliament and the Council of the EU. This course will guide you through this unique system, from its creation to the role of each institution.

To gain a better understanding of the main EU institutions.

The EU CTR (European Clinical Trial Regulation) comes into effect on January 31 2022 and affects everyone involved in clinical drug research in Europe, including paediatric drug trials. The EU CTR Expert course for clinical drug trials in Europe helps you understand all the vital aspects of the EU CTR regulation. You’ll learn all strategic elements, from study design, requirements to the paediatric investigation plan (PIP) to submission, to clinical conduct in our course, making you the EU CTR expert. Includes 4 interactive modules,1 test and takes 7.5 hours to complete.

• Principles of EU CTR (EU Clinical Trial Regulation)Transition period and expected implementation EU CTR
• Contents of submission dossier Part I and II, incl paediatric investigation plan (PIP)
• Preparing and submitting of the research dossier in the CTIS portal
• Role of the submitter, the reviewer,and the investigator
• Critical timelines for submission and review of a dossier
• How to answer questions from the reviewing ethics committee
• Requirements for the conduct of clinical drug research
• Safety reporting requirements
• Submitting substantial amendments via the CTIS
• End of trial reporting, summary of Clinical Trial Results for Laypersons
• Publication of trial data: requirements and transparency

• Understand the meaning of a “treatment effect” in a randomised controlled clinical trial.
• Understand different summary measures for treatment effects in clinical trials.
• Understand the interpretation of confidence intervals and significance tests.
• Understand the concept of power, its relation to study size and the importance of understanding false-negative outcomes.

All aspects of the medicines development process are subject to various degrees of regulation. In this course, you can learn more about the legal framework, guidelines, health authorities’ attitudes and requirements, which have a significant influence on the development process and its success rate. As patient advocates and researchers, it is important to understand the basic principles of regulatory affairs in order to be able to interact proactively with regulatory authorities.

1 Familiarise yourselves with the Medicines Regulatory world. The intention is not to make you Regulatory experts (though you might become one) but rather to give you an overview of the field so that you are more at ease interacting with the different actors.

2 Learn how Regulatory Affairs are embedded into pharmaceutical companies practices.

3 Develop an understanding of the general Medicines Regulatory Framework.

In this course, you will be able to learn more about the process of medicine discovery, such as pre-clinical testing, clinical trials and the methodology and statistics used in medicine development, including evidence-based medicine, blinding and study protocol.

Learn the full drug development process from discovery to post-market monitoring. Understand differences between medical and clinical research, and apply key Evidence-Based Medicine principles. Recognise essential study design elements like randomisation and blinding. Evaluate inclusion/exclusion criteria in trials and their ethical impact. Explore the unique challenges of research in rare diseases and how flexible designs can help.

The EHDEN Academy has been created as an online educational resource for anyone working in the domain of real world data and real world evidence. They have an online course that is designed to help patient organisations get up to speed with the foundational concepts of health data, and the basics of using health data in terms of creating, using and analysing it for research.

To understand foundational concepts of health data, and the basics of using health data in terms of creating, using and analysing it for research.

This course will address specific knowledge gaps to establish best practices for the care and management of children, adolescents and pregnant people living with viral hepatitis. Our goal is to provide timely and targeted support amid the ongoing global response concerning treatment and prevention of both acute and chronic paediatric hepatitis.

1. Infectious hepatitis in childhood – chronic & acute
2. Hepatitis B virus – virology
3. HBV infection in children – diagnosis, staging, monitoring
4. Prevention of vertical & horizontal transmission of HBV
5. Antiviral treatment & indications for treatment of HBV
6. Hepatitis C virus – viral genome, replication, heterogeneity
7. HCV virus infection in children
8. Diagnosis, staging & monitoring of HCV in children
9. Antiviral treatment & indications for treatment of HCV

The programme is led by a group of international experts from the Penta-ID network, and Fungal Infections and EPMyN working groups. The course consists of interactive clinical cases with animations and voice narrations, discussion forums, video presentations, live Q&A webinars and a wealth of further reading educational resources. Moreover, the course is a unique networking opportunity for participants, with the chance to engage with a wide range of delegates and leading experts from around the globe.

1. Fungal infections in children with haematological
   malignancies
2. HIV/AIDs associated mycoses
3. Invasive candidiasis in neonatal and paediatric intensive care settings
4. Fungal infections in children with primary
   immunodeficiencies
5. Neglected fungal diseases in children
6. Skin and mucosal mycoses in children

The course will will explore the basics of epidemiology, statistics and implementation science, outbreak investigation, setting up surveillance mechanisms for IPC, Personal Protective Equipment (PPE) usage, challenges and solutions for IPC in LMICs, tools for IPC and AMS programs, a wealth of further educational resources – not to mention unique networking opportunities!

This online course provides recommendations on the competencies (understood as knowledge, skills and behaviours) and resources that each stakeholder organisation should aspire to have in place in order to plan, implement and evaluate meaningful and sustainable patient engagement activities across the medicines lifecycle.

This course is based on one of the main outcomes of the IMI funded multi-stakeholder consortium PARADIGM (Patients active in research and dialogues for an improved generation of medicines).

The objective of this online course is to increase the preparedness of stakeholder organisations by identifying the capabilities required by those individuals involved in implementing patient engagement activities and the resources (processes, tools and systems, organisational structure) needed within the organisation.

This webinar explores why FAIR data is valuable by giving presentations from the perspective of different stakeholders including academia, industry, regulators and funders. This webinar was hosted by FAIR Plus, which is an IMI (Innovative Medicines Initiative) funded project.

To be able to understand the value of making data FAIR, from the perspective of different stakeholders.