Unlocking EMA's PMS Puzzle | Deloitte’s perspective on IDMP in Europe

In this broadcast Deloitte experts summarize the information presented by the European Medicines Agency (EMA) on the PMS info day of 16/Apr/2024. The broadcast summarizes the timelines for all regulatory processes and systems at EMA that (will) make use of the central PMS database. This includes the PMS database itself (Product Management Services), the European Shortages Monitoring Platform (ESMP), the web-based electronic Application Form (PLM eAF), electronic Product Information (FHIR ePI), the Regulatory Procedure Management on the IRIS platform (RPM for PLM), and the veterinary Antimicrobial Sales and Use platform (ASU). The broadcast provides the projected timelines and the actions that industry will need to take, with a focus on the regulatory department.
Remco Munnik, Director at Deloitte and expert in electronic submissions, shares all the latest developments around EMA’s roadmap for Identification of Medicinal Products (IDMP) data standards, with the Product Management Services (PMS) database at the core. Frits Stulp, Life Science & Health Care industry lead for Deloitte NL, presents his views on the broader impact of EMA’s plans on industry based on his years of experience working with both marketing authorization holders and regulators. The session is moderated by Jeanneke Spruit, Senior Consultant Regulatory Information Management at Deloitte.