Introduzione
As defined by the EMA, "ePI refers to the authorized, regulatory product information for medicinal products (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and distribution via the web, e-platforms and print".
This course aims to provide an overview of the latest developments within EU ePI, EMA's PLM portal and integration with other initiatives such as PMS / SPOR Master Data.
A high-level overview of the Fast Healthcare Interoperability Resources (FHIR) data exchange standard, the impact of ePI on pharmaceutical companies and an outline of three approaches for ePI approaches/implementation, including an analysis of their benefits vs. risks, will be covered.
In addition, the course will explore in more detail how to manage product information as an electronic data asset and how to use this information as an organization to gain business value.
This course will help you to understand and gain insight into the current landscape of ePI and other obligations.
- Introductions
- EMA Telematics Update and latest developments on ePI
- Deep-dive into ePI, the technical implementation and impact on Industry
- Conclusion and closing
This course is aimed at individuals working in the Regulatory Affairs Professionals, Quality Assurance Specialists, Pharmacovigilance Officers, Medical Information Managers, Labeling and Artwork Coordinators.
Interactive presentations.
Docente/i
Remco Munnik
Remco holds more than 20 years of experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
Additionally, he is also an active member of EMA ISO IDMP Task Force for Organizations (OMS) and Products (PMS); Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.
Nadia Goutziers
Nadia has 6+ year experience in the Life Sciences industry, including various areas of the Regulatory Affairs department, including labeling.
Her diverse background is a strong enabler in projects, allowing an effective translation and implementation of diverse requirements of involved stakeholders.
Throughout her projects, Nadia has designed and executed process work for global labeling (including structured content authoring), but also other initiatives, such as IDMP and web-based eAF readiness analyses, data and process mappings, data and process pilots, risk assessments, IDMP and web-based eAF Operating Models, trainings, stakeholder interviews, stakeholder work sessions and workshops.
Online Training – 1 module
20 November 2024 from 2:00 pm to 6:00 pm CET
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 510,00* (until 30/10/2024)
Ordinary: € 645,00*
Freelance – Individual – Academy – Public Administration**: € 435,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Roberta Alberti
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
