The c4c Academy Platform provides educational courses and training materials tailored to the needs of all the c4c beneficiaries involved in the conduct of paediatric clinical trials. Through these courses, c4c beneficiaries will gain greater insight and expertise into all relevant aspects of the organisation, implementation and delivery of paediatric clinical trials, including those focused on regulatory approval of new paediatric drugs.
This course aims to educate healthcare professionals about the scientific, methodological and practical issues of the design, conduct, analysis & management of clinical trials in paediatrics.
The course is designed for clinical research personnel, who have already completed a Basic GCP course (not necessarily the c4c one) to refresh their knowledge.
The course is designed to familiarise you with the essential documents needed for a Clinical Trial, following the guidelines of Good Clinical Practice.
This course focuses on the monitoring aspects of paediatric clinical trials, including the role of the monitor (CRA), site staff responsibilities, monitoring plans and study specific procedures (SSP).
The course focuses on safety data reporting in paediatric clinical trials, following Good Clinical Practice and Good Pharmacovigilance Practice guidelines.
This course provides a general overview of activities required to start paediatric clinical trials in sites, in line with international and European standards, taking into account the specific guidelines for trials involving children.
This course will present the key aspects of developmental pharmacology, covering the impact of growth and maturation on drug disposition, effects on dosage selection and evaluation in the different paediatric age groups.
This course provides the basic elements of clinical research methodologies focusing on understanding clinical research results and learning the basics of writing research papers.
This self-learning course gives an overview of some key features of gene therapy clinical trials and how the set-up of these trials can differ from other clinical trials.
This course provides an introduction to various types of innovative clinical trial design, including adaptive designs, platform trials & precision medicine approaches.
This course aims to enable students to identify activities in the development of clinical trials in which patients can contribute. Students will learn about the design of appropriate methodology and impact assessment.
This course introduces key aspects of investigational medicinal product supply planning, including regulatory requirements, blinding, placebo supply, and forecasting.
This course will explain how registry data can be used within all phases of paediatric clinical trials, the ethical and legal aspects of using registry data and how regulatory level data can be generated.
This one day Live course will provide an opportunity to learn how to conduct remote and hybrid clinical trials and manage emergency situations that may arise during home therapy.
