Geraldine Dal Pra

Almost 30 years’ experience in clinical research: from 1994 as a CRA for a Swiss CRO, from 1999 as a Quality Assurance Manager, founding the QA Department of the company; from 2012 to 2021 as a Director Clinical Quality Assurance for an international CRO. Main areas of expertise are:  Development, revision, review and training of SOPs and other QMS documents Planning and conduct of different types of project specific (e.g. TMF, investigation site and CSR audits), system and vendor (including Phase I units) GCP audits.  Preparation and hosting of GCP sponsor audits and inspections performed by regulatory agencies (in Switzerland and Italy) as well as preparation and coordination of the audit/inspections’ follow-up activities  Management of CAPAs Development of Risk Management Plans Speaker for GCP trainings and seminars for investigators and pharmaceutical companies (in Switzerland trainings accredited by Swissethics) as well as for pre-inspectional trainings.