PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.

Raj has more than 20 years’ experience in post-authorisation and clinical trial pharmacovigilance. Since 2005, she is trainer for Eudravigilance and the Eudravigilance Product Dictionary courses. Raj is consultant member on the editorial board of the Regulatory Rapporteur Journal. She is a BSI qualified lead auditor for ISO 9001, a member of the Oxford Research Ethics Committee and the UK’s Health Research Authority Phase I Advisory Panel. She has a background in biochemistry and toxicology. Raj works as a consultant.

Monika Gappa is a Pharmacovigilance professional with a degree in Pharmacy from Medical University in Gdansk, Poland. She has 6 years of expertise in PV with a wide background in the fields of XEVMPD and EudraVigilance set-up and maintenance. Additionally, she has managed local, global and regulatory intelligence projects as well as supported Health Authority inspections and client audits. Since 2020, she is the PV Network Coordinator of Local Contact Persons for Pharmacovigilance for more than 25 countries. It is the broad range of experiences that gives Monika a different perspective on the industry she works in.