Introduzione
European pharmaceutical regulation is rapidly evolving.
ISO IDMP (Identification of Medicinal Products) has become central to how authorities and companies aim to structure their medicinal product data, including unique identification, registration details, and lifecycle information.
This focused module equips you with a clear understanding of the IDMP data model, current implementation landscape in the EU through SPOR, and the strategic value of aligning your processes with regulatory expectations.
The training will cover the theory behind IDMP, but will also provide you with practical use cases to get started within your own organisation.
- Introduction
- The need to identify products
- ISO IDMP datamodel
- ISO IDMP implementation status
- EU Implementation History and status
- EU Implementation Guide
- Use cases
- Impact of IDMP
- Regulatory Optimization
This course is designed for professionals working in the pharmaceutical and life sciences industry who are directly or indirectly involved in product data management, regulatory submissions, or process optimization, including:
- Regulatory Affairs specialists and managers
- Regulatory Operations specialists and managers
- Pharmacovigilance professionals
- Data Management and Master Data teams
- Quality Assurance and Compliance teams
- Supply Chain and Operations managers
Participant experience
Basic understanding of Regulatory processes and medicinal product data, including related systems such as PLM electronic Application Form and/or xEVMPD.
Highly interactive training
Docente/i
Remco Munnik
Remco holds more than 25 years of experience in Life Science and Regulatory Affairs. With more than a decade dedicated to consultancy around Regulatory Information Management (RIM) and electronic submissions, he has established himself as a prominent figure in the industry. He is a highly-regarded speaker, passionately sharing his insights on eCTD, ISO IDMP, and the importance of a data-driven way of working.Remco’s influence extends into numerous organizations where he actively participates and holds leadership roles. These include Medicines for Europe, where he serves as the Chair of the Regulatory Data & Digital Systems (ReDDS) group; he is President of the IRISS Forum: a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals; and Remco is a member of the Regulatory Optimization Group (ROG) where EMA, HMA and industry come together.
Jeanneke Spruit
Jeanneke brings 5 years of experience as a consultant in Regulatory Information Management within the Life Sciences industry. As a consultant, she partners with her clients on topics like data management, Regulatory system landscape, and IDMP / xEVMPD compliance. Clients appreciate her cross-industry experience and up-to-date knowledge on the global implementation of regulatory data standards.
Jeanneke feels right at home in the details of the ISO IDMP data standards and data model, and she is able to translate this complex material into clear stories with practical examples that attendees can immediately apply to their own regulatory work.
Online Training – 2 modules:
MODULE 1 | 19 November 2025 from 2:00 pm to 5:00 pm CET
MODULE 2 | 20 November 2025 from 2:00 pm to 5:00 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: € 745,00* until 29/10/2025
Ordinary: € 935,00*
Freelance – Individual – Academy – Public Administration: € 530,00*
*for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
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.