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!

SPASD course, developed as part of the SPASD project, with the sponsorship of the University of Bari “A. Moro ”, aims to guide teachers in the delicate process of inclusion of students affected by Autistic Spectrum Disorders (ASD).

In order for a student to be able to successfully complete an inclusive or ordinary course, it is essential that teachers have knowledge of the autism spectrum and what this condition entails for students in the school environment.

Structure of the course

The course is composed of the following four modules:

1. Understanding and managing ASD in the classroom
2. Curriculum adaptation for students diagnosed with Autism Spectrum Disorder
3. Information and Communication Technologies (ICTs) and Autistic Spectrum Disorders (ASD)
4. Transition from school to adult life of ASD students

Before each Module there is a self-assessment quiz, while at the end of each module it will be possible to access a final test consisted of ten questions. Only by passing this test it will be possible to start the next module. If all the four tests are successfully completed with at least the 80% of corrected answers, a certificate of training will be released.

Access to the course

The course is available online on the dedicated e-learning platform (https://teachasd.com/?lang=it) and all the materials can be viewed via web or saved by the user on the computer.

To start and access the course, the user should register himself/herself by filling in the registration form available at this link: https://teachasd.com/wp-login.php?action=register&lang=it

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.

In the framework of “Estrazione dei Talenti” programme, an initiative promoted by Apulia Region, the Factory EVOLUTIO STARTUP, has been kicked off with the aim to support the evolution and consolidation of the individual business initiatives, through specific pathways of mentoring and coaching focused on technological transfer and business development, initiatives to support the strategies definition, business models and business plans, thus helping the start-upper Teams to achieve a good level of prospective sustainability and to promote the possible transformation of “ideas of business” in real innovative companies. Factory EVOLUTIO START UP will include a pool of experts coming from CVBF, the University of Bari, Gianni Benzi Foundation, the Bioindustry Park (BIPCA) and the National Research Council (CNR) of Bari.

Structure and operational methods

The interventional programme foresees different phases. A screening phase foreseeing a meeting with each Team interested in the programme. During this phase, the teams will be identified as “low”, “medium” or “high” entrepreneurial maturity level. According to the category, different training activities and interventional initiatives will be undertaken.

Common sessions will be conducted by expert personnel in order to homogenize the language and the fundamental themes (Entrepreneurship and innovation management), as well as the critical nodes related to the genesis and the development of business plans. In these sessions the Teams will receive focused “transversal” know-how especially on organization and business management. Later on, each Team, in the specific training course, will then apply the theory to its specific case thanks to the support of its own Coach.

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).