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.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors

Course elements:
• Introduction to drug development
• The need for clinical studies in the pediatric population
• Declaration of Helsinki
• good clinical practice – ICH GCP (E6 R2)
• Clinical study protocol for Pediatric studies
• Vigilance
• Applicable local regulations

In this training, learners will understand the benefits of adopting CDISC standards. The training will also provide academics with a useful toolkit and helpful information for collecting and organizing research data using CDISC standards. This training also outlines navigating CDISC resources and how to contribute to clinical research standards development.

• Describe the CDISC standards and how they improve the findability, accessibility, interoperability, and reusability of research data in order to recognize their value in academic research.
• Identify individual CDISC standards in order to set the stage for implementation.
• Support the adoption of implementing CDISC standards for data collection and organization in academic research.

This webinar, presented by some of the foremost CDISC experts, will cover the fundamentals to get you up to speed on the what, how, and why of CDISC standards. We will address such topics as:

• The need for global standards in the current industry environment,
• An overview of the CDISC Model
• Regulatory requirements
• Use cases for CDISC Standards.

To provide an introduction to CDISC and the use of data standards.

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).

The conference will focus on Global Paediatric Development, its challenges and solutions, and in particular on what has been achieved during the pandemic, and the remaining opportunities and challenges. To this effect, the conference brings together distinguished speakers from all around the world and all stakeholders involved in paediatric drug development.

To bring together all stakeholders in paediatric drug development to discuss challenges and solutions, as well as share best practice.

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.

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.

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 face to face symposium will take place at the AC Hotel Marriot in Genoa, Italy. This symposium includes lectures, workshops and clinical cases. EPAS will provide a unique opportunity to understand the evolving techniques and equipment available for paediatric airway management. The course is open to 100 health care professionals. This course is accredited by ECM (29 credits).

Strengthen collaborative care and share knowledge between different specialties (Anaesthesiologists, ENT
surgeons, Intensivists, Neonatologists, Pneumologists and Radiologists) involved in the paediatric airway
management with the aim to improve patient outcome.

Have a better understanding of the evolving techniques and equipment in paediatric airway management in
order to improve clinical care.

Identify the challenges raised by the difficult paediatric airways and learn about the
best strategies to master these challenges.

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

The MRC NIHR Trials Methodology Research Partnership aims to Improve health by improving trials. 3 year funded studentships are available in statistics, data analytics and informatics, computer science,
health economics, qualitative methods, mixed methods, clinical medicine and psychology

Students will become members of the TMRP, offering a broader spectrum of training activities and networking opportunities beyond their host Research Organisation. Students will be encouraged to join relevant TMRP working groups, where they will meet other PhD students, post-doctoral researchers and senior academic staff from relevant and complementary research themes. In addition to a structured ‘core’ training programme, we are able to provide a range of more specific training that students may choose to attend following consultation with their supervisors.

This is the first University-accredited postgraduate programme in Paediatrics and Child Health in Ireland and forms part of a unique suite of Paediatrics and Child Health courses, designed so students who complete the Postgraduate Certificate have the option to proceed to a Diploma and Masters level qualification.

These Paediatrics and Child Health courses were established by the Universities College of Medicine and Health to meet the demand for dynamic multidisciplinary healthcare models for treating children. The course is designed for busy healthcare professionals, including those working full time, who want to learn flexibly. Offering a broad coverage of the scientific basis of childhood disease, the principles of evidence-based paediatric medicine, and focus on the various multidisciplinary assessment and treatment approaches within the field of paediatrics.

On successful completion of this Certificate course, you will be able to:

Outline a systematic approach to new-born and infant clinical assessment;
Define the principles of managing common illnesses in infants and children;
Describe the principles of assessing and managing a febrile child with reference to sepsis;
Outline the roles and responsibilities of the multi-disciplinary team in child health;
Describe the assessment and management of accidental and non-accidental injuries in children.

This training programme utilizes a child-centered teaching model to support ongoing learning
needs with innovative e-learning methods. Modules include:

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

• To highlight knowledge gaps and provide more guidance around existing treatment strategies and guidelines using case-based teaching (incl. relevance to the LMIC setting)
• To share specialist knowledge and experience in the management of paediatric fungal infections
• Building and enhancing in national international networks for future collaborations and clinical support – providing lasting links to allow ongoing sharing of expertise
• Linking centers for clinical care, as well as epidemiological and clinical research
• To promote and share best practice in clinical research
• To foster meaningful, enduring and verifiable change in day-to-day clinical/professional practice.

As well as presenting the impact of the platform on drug development and data analysis in rare diseases, this workshop will also address case studies and will include industry expert presentations as well as panel discussions on the importance of building a rare disease community that works together to share optimal data and generate actionable solutions for the benefit of all rare disease patients.

The workshop will take place in person at the Westin Crystal City Reagan National Airport, Arlington, USA. It is possible to register to attend virtually but this is only possible for the first day of the workshop and it will be via live stream.

To gain an understanding of:​

• RDCA-DAP’s current and future impact on drug development in rare diseases from the perspectives of patients, regulators and industry partners
• How RDCA-DAP is unique in supporting multiple data and analysis-types across rare diseases
• The critical importance of building a rare disease community that works together to share optimal data and generate actionable solutions for the benefit of all rare disease patients

This interactive online course will provide an understanding of current techniques, opportunities and challenges for the use of real-world evidence 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 and wishes to broaden their expertise.

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).

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.