José Ortiz, CEO of PVpharm, will be participating as a trainer in the upcoming EVWeb training, scheduled from Monday, 02 December to Friday, 06 December 2024. This comprehensive online training will take place all day and is tailored for professionals involved in reporting and analyzing suspected adverse reactions.
About the Training
EudraVigilance is the EU’s system for managing and analyzing information on adverse reactions to medicines authorized or studied within the European Economic Area (EEA). This training focuses on the mandatory use of the ISO Individual Case Safety Report (ICSR) standard, based on ICH E2B(R3) modalities, which became effective on 30 June 2022, along with the use of ISO standard terminology for dose forms and routes of administration.
Participants will learn to:
- Report and analyze suspected adverse reactions during clinical trials and post-authorization phases using the ICSR format.
- Operate as Gateway traders or WebTraders using EVWEB or EV Post.
- Fulfill electronic reporting obligations to EudraVigilance.
Who Should Attend?
The training is designed for:
- EudraVigilance users – both new and experienced.
- Pharmacovigilance professionals, including QPPVs/RPs, involved in drug safety reporting.
- Sponsors of clinical trials and regulatory professionals.
- National Competent Authorities or their representatives.
Certification
Participants who pass the knowledge evaluation will receive a notification from the EMA. Organizations registering their first user for the EudraVigilance web application (EVWEB) or initiating ICSR electronic reporting must submit this notification to the EMA to complete the registration process.
📌 Read more and register here. You can contact us for further information.
Don’t miss the opportunity to enhance your EudraVigilance skills with guidance from experienced trainers like José Ortiz.
Check Out: A Milestone Partnership: PVpharm & Teófilo Hernando Institute – PVpharm
