Addressed to professionals working at public bodies, research institutes and private companies, CVBF’s training activities support the Consortium’s areas of expertise. CVBF is also involved in the design and execution of Continuing Medical Education (CME) programmes.
The main residential training activities organised with its Partner FGB are the annual Foresight Training Courses, short intensive face-to-face courses for experts in the field of regulatory sciences acting in public and private sector aimed to share the existing knowledge in the field and to promote their integration into the European regulatory context. Participants from more than 20 EU/non EU Countries have been involved in the eight courses organised until today.
To date, the following e-learning courses have been realised:
- Authorisation procedures for multi-centre and multi-national trials
- Marketing a drug for human use in Europe
- Procedure autorizzative per studi multicentrici e multinazionali
- Le procedure di registrazione dei farmaci in Europa
- The relationship and the communication with the thalassaemic patients
- Children are not little adults
- The European Paediatric Regulation
- Paediatric status and off-label use of drugs in children
- Clinical trials involving children – Methodological aspects
- Clinical trials involving children – Ethical aspects
- Pharmacoepidemiology and drug utilisation in childhood
- Pharmacovigilance and drug adverse reactions in paediatrics
- Innovative medicines and orphan drugs for children
- Therapeutic needs in the paediatric population
- Teddy results
In addition, the following two modules of the International “Master of Science in Paediatric Medicines Development and Evaluation”, awarded by the University of Rome “Tor Vergata” School of Paediatrics in collaboration with the Children’s Hospital Bambino Gesù, in the context of the GRiP project have been developed and coordinated:
- Experimental Drug Evaluation in Paediatrics (Module 4);
- Biomarkers and Innovative Tools in Paediatric Clinical Pharmacology (Module 9).
Moreover, CVBF has developed a TransCelerate BioPharma accredited ICH-Good Clinical Practice (GCP) Training Course.
The “ICH-Good Clinical Practice (GCP) Training Course”, is an e-learning training course lasting 3 hours aimed at providing a guide for all individuals that are involved in clinical research and clinical trials and they need to acquire GCP recognized certification. The e-learning training course is based on the international E6 ICH Good Clinical Practice (R2), revised in 2016, and 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. The ICH-GCP training course is intended to provide indication for all the steps of a clinical trial, starting from the planning phase and Ethics Committee submission, passing through the trial conduction and up to the reporting of results.
Structure of the course
The course is available online on a dedicated e-learning platform (www.gcptraining.cvbf.net) and all materials can be viewed via web or saved by the user on the computer. The course is structured in 3 parts: an introductory presentation of the training course and 2 modules, each about one hour and a half. Each part is constituted by a PowerPoint presentation supported by audio comments.
Access to the course
To access the course, the user should register himself/herself by filling in the registration form available at the “ACCESS TO THE COURSE” page to create his/her account. Once the user has already registered himself/herself and created the account, he/she can log in at the LOGIN page to access the course material.
Start the registration here!