Aurélie WEISS

Temporary Contract (CDD) within Global Medical Affairs – Clinical Operations Department.  Ensure and coordinate the public disclosure of Medical Affairs studies. Participate in the implementation of the new paediatric regulation Exploit the data of Medical A ffairs database

Internship within Global Medical Affairs – Clinical Operations Department. Set-up and updating quality documents and procedures (SOPs) within all GMA-CO department. Develop communication supports and training of quality documents. Ensure communications through Regions and Affiliates.

Internship in Research and Development. Implementation of protocols for the studies on the interaction between apolipoprotein H and Escherichia coli by bioluminescence. Analysis of study-results with the aim of writing scientific publications.

Internship in Clinical Research. Follow-up of clinical trials in phase III of Adalimumab (HUMIRA) in Crohn disease by executing co-monitoring visits in clinical sites. Knowledges regarding GCP - ICH Training in audit processes (Quality Assurance) and other GMP processes for customers.

Responsible for two disease registries and one prospective product registry (Diabetology and Cardiology areas): -Liaising with Competent Authority (MoH) and Ethics Committee to obtain approvals to conduct the study, -Setting up Investigators’ meeting to initiate the study and to present the study documents, -Setting up the study from the start-up stage, through initiation and monitoring to closing out of the study sites,

Pharmaceutical development