Xendo CEO André van de Sande moderating a session about Strategies for growth for Life Sciences companies at the recent Dutch Biotech Event. Synthon and Merus shared their insights about their successful company strategies.
Helena had joined Novartis in 2007 as Regional Head Clinical Quality Assurance (CQA) Auditing and subsequently became the Global Head of Country Management. In 2009 she became the Global Head of Drug Safety and Epidemiology Quality Assurance.
Prior to joining Novartis, Helena was a Senior Inspector at the Inspectorate of Health Care of the Netherlands (for GLP, GCP and PV and related regulated fields). In this role, she was responsible for the design, implementation, and execution of inspection and compliance programs for GLP, GCP, Pharmacovigilance, Ethics Committees and related regulated areas for the Dutch, European, and Global Health Authorities. Besides this, she also acted as a subject matter expert for various regulatory working parties for the Dutch Authorities and the European Commission.
Understanding pharmacovigilance regulations and requirements, access to a wide range of services, and a senior expert team are repeatedly highlighted as essential criteria when clients select Xendo Pharmacovigilance as their flexible service provider. Working globally, we understand international requirements. Being consistently quality driven and customer focused has led to a proven track record of meeting or exceeding clients` expectations. We are also regularly asked to lecture or moderate at international seminars and symposia as experts in the field.
From the outset, we have been a full-service provider for pharmacovigilance. Due to a sound Quality Management System we ensure that all activities conducted for and on behalf of clients are in line with applicable standards.