CEO at Insife
Executive leader with 10 years of experience within the pharma industry and another 10+ years in consulting. Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance. His current role is CEO of Insife, a global consulting and technology company. In this capacity, digital transformation is central to Martin’s engagements with Industry and Regulatory Agencies. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating.
Title: Multivigilance – re-inventing the vigilance system for drug safety with devices, complaints, counterfeits etc.
With the introduction of new legislation such as the EU MDR or the FDA combination product reporting, maintaining vigilance is becoming increasingly interconnected.
In this session, we will talk about process orchestration, computerized workflows, signal detection and automation/AI approaches to Multivigilance, and ultimately pose the question: Is the role and the remit of the PV department changing and therefore in need of a re-alignment within organizations ?