Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Jun 30, 2025 2:00 PM - Jul 04, 2025 6:30 PM

(Central Europe Standard Time)

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS.

Faculty

Raj  Bains

Raj Bains

Principal Consultant, Gxpconsult Limited, Germany

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.

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Isabella  Palagiano

Isabella Palagiano

Deputy QPPV/LCPPV, PVCS Line Manager, PVpharm, Spain

Isabella Palagiano graduated from Alma Mater Studiorum, University of Bologna with a master’s in Pharmacy&Pharmaceutical Industry. She is a PV professional with more than 5 years of experience on different positions across pharmacovigilance, with the main focus on ICSR Management, SPOR, EudraVigilance and XEVMPD set-up and maintenance, Deputy EU/UK QPPV activities, Local Contact Person for Pharmacovigilance, PSMF maintenance, audits/inspections and project management in post-marketing and clinical trials. From the beginning of her career, she has been involved in the maintenance of the XEVMPD and EudraVigilance operations for both Sponsors and MAHs.

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.