Valentina Berruti has more than 8 years’ experience in preparing ethics committee and regulatory authority submissions for both drug and device clinical studies, in addition to supporting clinical monitors (CRAs) and project managers in clinical study management.
Ms Berruti graduated in Psychology from Rome University, with a thesis on the difficulty in communications between clinical investigators with different therapeutic cultures, followed by an masters degree in Human Resource Management. After leaving University, she worked first at Pfizer where she was responsible for collecting and reviewing regulatory documents obtained from clinical trial sites to ensure compliance with local, European and FDA regulations. After moving to work with a small CRO in the Regulatory Approval Department, she then moved to Covance, where she worked for nearly 4 years, performing feasibility studies, regulatory reviews of study documents, ethics committee and regulatory authority submissions, budget negotiations, and site activation and maintenance. Her experience spans several therapeutic areas among which are cardiology, oncology, psychiatry and hematology.
At Donawa Lifescience Consulting, Ms Berruti helps clients with ethics commiittee and competent authority clinical study submissions for both pharmaceutical and medical device projects, in addition to supporting the clinical monitoring and management and regulatory functions of the company.