Navigating EMA PMS Requirements: A Strategic Guide for Regulatory Leaders.
Authors:
Manfred Voglmaier – ACCURIDS
Raphael Sergent – ACCURIDS
Michiel Stam—MAIN5
Dominik Gigli – MAIN5
A Strategic Guide for Regulatory Leaders.
Regulatory requirements in the pharmaceutical industry are becoming more stringent.
By 2026, IDMP compliance will become drastically more challenging for all pharmaceutical companies operating in the EU due to the broader adoption of the IDMP data model. The EMA Product Management Services (PMS) Requirements present a strategic opportunity, not just another regulatory burden. This whitepaper provides actionable insights for regulatory leaders to streamline compliance, enhance efficiency, and drive competitive advantage.
By understanding and implementing the ISO IDMP standards and, therefore, aligning to EMA PMS requirements, pharmaceutical companies can streamline their regulatory submissions, improve data accuracy and facilitate efficient communication with
regulatory authorities. This proactive approach not only ensures compliance but also enhances the accuracy of product lifecycle management, ultimately leading to faster approval times and improved market access.
This whitepaper is designed for regulatory professionals and decision-makers in the pharmaceutical industry, including:
Heads of Regulatory Affairs & Compliance:
Ensuring alignment with EMA PMS requirements and IDMP standards.
Regulatory Operations Teams:
Managing data standardization and submission processes.
IT & Digital Transformation Leaders:
Implementing and integrating PMS-compliant data infrastructures and exchanges.
Quality & Pharmacovigilance Professionals:
Enhancing data accuracy and patient safety.
