Dear PhD students,
Dear Post-docs,
Dear Academics,

We are pleased to invite you at the following symposium : “PhD Training in clinical research: from project drafting to study completion” on May 30^th 2024

Are you managing a clinical study/trial?
Do you want to get trained with basic knowledge in clinical research?

We organize a unique symposium for PhD students.

Please see below the detailed program.

Registration is mandatory for all day before May 10^th : https://forms.office.com/r/AtbCD5tLev

PRACTICAL INFORMATION :

All sessions in English; max 100
Please subscribe via Google Form
Location : Auditorium Maisin – Avenue E. Mounier 51 – level 0
Lunch and closing drinks are included (on registration)
Doctoral training credits : for PhD students: 3 ECTS (3 credits ‘transferable skills’ training) – certificate of attendance
For more info : julie.vanacker@uclouvain.be

Program of the training

Session 1. Introducing the context and rules

• 9.00: Introduction - Nathalie Delzenne (Research coordinator in Health Sector)
• 9.10: Presentation of the structure of the UCLouvain and related hospitals. Key contacts in all organizations - Christophe Depoix
• 9.30: Context of belgian and european regulations/competent authorities regarding the different types of substances (Case studies) - Julie Vanacker

10.00: Questions, discussion and break

• 10.20: Specificities of Clinical Research in Industry – Bernard Hoet from Bavarian Nordic pharmaceutical company (Switzerland)
• 10:50: Introduction to Good Clinical Practice GCP Dominique Van Ophem (Clinical Trial Center, CUSL)
• 11.20: UCLouvain biobank : regulatory requirements (incl. Ethical requirements) Ilse Gutierrez

11.50: Questions and discussion

12.00: Lunch

Session 2. Application of the rules to clinical research project elaboration and data management

• 13.00: Statistics : sample size calculation, Statistical Plan incl. REDCap training presentation - Céline Bugli and Valérie Dormal
• 13.45: DMP online Christophe Depoix
• 14.15: Data protection, GDPR and data sharing Joëlle Desterbecq (to be confirmed)
• 14.45: Management of a clinical study : amendments, closure, monitoring, … Julie Vanacker

15.10: Questions, discussion and break

Session 3: Practical and self-training

• 15.30: Sharing of experience from a PhD students/postdocs and a study nurse
• 16.15: Practical training : case studies presentation according to your own protocol/submission papers/Trial Master file - Julie Vanacker
• 17.15: Closing remarks; Presentation of tools available (informations, links on UCLouvain/ SSS web ….)

17.30: Closing drink and networking