Alessandra Sola

Regulatory & Start-up Manager @IQVIA

Milano, IT

Responsible for the set-up and execution of regulatory related tasks within the designated clinical projects in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and IQVIA MedTech SOPs. Acts as an intermediary between the different parties involved, which may include a Regulatory Authority, Ethics/Review Committee, study investigators, third party vendors (e.g. consultants and translation agencies) and the client. Final responsible for performance of correct and complete submissions to EC, IRB, NCA or any other reviewing body involved in the clinical study.Acts as a contact person for all regulatory related aspects within the organization. Evaluates and formulates recommendations or improvements to company systems & processes to ensure clinical study regulatory issues are identified and resolved.Writes and/or provides input to department specific SOPs and Working Practices.Assures adherence to ICH-GCP, compliance with IQVIA MedTech regulatory SOPs, study procedures and regulatory requirements.Provides ongoing coaching and development of training materials to new staff or where needed.

Università degli Studi di Milano

Degree Chemistry and Pharmacological Techniques, Farmacologia