Enrolment open from 16th Sep to 18th Oct 2024


Name of the course: Safety Data Reporting

Edition of the course: First Regular Edition

Start date: 21st October 2024

End date: 24th November 2024

Enrolment Dates: 16th Sep to 18th Oct 2024

Course Duration: 7- 8 hours over 5 weeks

Please see enrolment procedure below!
Once enrolled and you have received your password, please log in on c4c Academy Platform to begin your course.
If you don’t have an account yet, click on Create new account and follow the instructions.


General Description: 

The course focuses on safety data reporting in paediatric clinical trials, following Good Clinical Practice and Good Pharmacovigilance Practice guidelines. The reading material will introduce you to the topic and lead to the animated video lessons. The video lessons aim to capture the lively discussion that takes place among all interested parties, paediatric participants, their caregivers, and investigators but also sponsors, drug agency and Ethics Committee representatives, and patient advocates during the evaluation of a paediatric clinical trial. During the 4th week, a webinar will be held with all students to explore the topic more deeply. In addition, an online discussion forum will be available throughout the course to allow students interact with the teachers and among themselves easily.


Programme:

  • Week 1: Study of background material provided by the teachers;

  • Week 2 and 3: interactive animated video-lessons;

  • Week 4: webinar on the c4c VLE Platform – Tuesday, November 12th at 2:00 pm

  • Week 5: final exam and certification.

A discussion forum will be available on the c4c VLE Platform during the course.


Who should apply?

Health care professionals involved in clinical trials regarding neonates, children and adolescents.


Max. number of persons that each national hub can enrol: 20: 1 per each National Hub

The minimum number of participants to activate the course is 10.

Bloom’s Taxonomy Level of the Course:  3,4,5


Faculty:

  • Lenka Souckova (lsouckova@med.muni.cz)

  • Salma Malik (salma.malik@ecrin.org)

  • Pavla Pokorna (pavla.pokorna@vfn.cz)

  • Katerina Nebeska (nebeska@med.muni.cz)

Enrolment Procedure

  • The enrolment time opens on the 16th Sep 2024 until the 30th Sep 2024

  • Each National Hub can select 1 CANDIDATE (who meets the eligibily criteria) and provide them with the course’s enrolment password.

  • The selected candidates must enroll to the course before the enrolment’s deadline (30th Sep 2024)

  • After the enrolment deadline passes – and ONLY if there are vacant places (less than 20 enrolled) – c4c Academy Management Secretariat will inform the National Hubs that there are “xx” spots remaining on the course.

  • At this point there will be an “extraordinary enrolment phase” – beginning on 1st Oct and ending on the 18th Oct 2024.

  • The National Hubs and the EFPIA Partners can, at this point, enroll participants with no number limitations until the 20 is reached: the vacant places will be assigned based on a precedence criterion (who enrolls first gets the spot).

  • Enrolment will close as soon as the maximum number (i.e. 20) is reached

  • If less than 10 participants enrol the course will not be carried out (if the number of students enrolled is less than 20 only 1 webinar will be carried out).