17 April - 12:00 - 13:00 BST / 13:00 – 14:00 CET
EMA PMS Data Alignment: Automating Medicinal Product Data Compliance with improved Operational Efficiency
The European Medicines Agency (EMA) is tightening its regulatory framework, requiring pharmaceutical companies to manage highly structured and harmonized data. These expectations put significant pressure on companies, stretching their resources and testing their ability to comply effectively. Existing data silos disrupt operations, introduce inconsistencies, and increase the risk of errors, making compliance even more challenging.
As a result, organizations struggle to gain critical insights or leverage advanced technologies like Artificial Intelligence (AI) and automation, stalling their progress and innovation. Manual efforts consume valuable time, drive up operational costs and divert resources from innovation and ultimately slowing down productivity. Failure to comply with EMA regulations carries serious risks as it can lead to delays, financial penalties, and damage to an organization’s reputation. With the stakes higher than ever, timely and precise compliance is essential for maintaining operational stability and competitiveness.
EMA’s Product Management Services (PMS) initiative presents an opportunity to drive regulatory harmonization, enhance data accessibility, and ultimately strengthen patient safety. This presentation will demonstrate how companies can overcome these challenges through an innovative data synchronization strategy. A key enabler of this transformation is data standardization through the IDMP Ontology, which establishes a common data model for regulatory information. By leveraging structured data, companies can achieve automated data synchronization and comparison, reducing redundancy and ensuring alignment with evolving regulatory requirements.
Attendees will explore the automation process, the role of IDMP in streamlining compliance, key implementation strategies, and real-world case studies demonstrating how automation transforms regulatory obligations into a strategic advantage with enhanced efficiency and accuracy.
Learning Objectives:
1. Understanding EMA's Regulatory Framework: Gain insights into the tightened regulatory requirements by the European Medicines Agency (EMA) and the importance of precisely and timely managing structured and harmonized data for compliance.
2. Challenges of Data Silos and lack of advanced technologies: Learn about the operational disruptions, inconsistencies, and risks introduced by existing data silos, and how they impact compliance efforts. Discover how the lack of critical insights and advanced technologies like AI and automation can stall progress and innovation within organizations.
3. EMA’s Product Management Services (PMS) Initiative: Explore the opportunities presented by EMA’s PMS initiative to drive regulatory harmonization, enhance data accessibility, and strengthen patient safety.
4. Automation in Compliance: Understand how leveraging structured data can achieve automated data synchronization and comparison, reduce redundancy, and ensure alignment with evolving regulatory requirements. Learn about innovative data synchronization strategies and the role of data standardization through the IDMP Ontology in establishing a common data model for regulatory information.
5. Implementation Strategies and Case Studies: Gain practical knowledge from key implementation strategies and real-world case studies demonstrating how automation can transform regulatory obligations into strategic advantages with enhanced efficiency and accuracy.
Target Audience:
This webinar is designed for key professionals in pharmaceutical companies responsible for Regulatory Affairs, Compliance, and collaboration with regulatory authorities such as the EMA and FDA. These roles are crucial for ensuring that all pharmaceutical products and processes comply with regulations, working closely with R&D, production, quality assurance, and IT to bring safe, effective, and compliant medications to market.
Speakers
Michiel Stam, Regulatory Consulting Lead at MAIN5
Michiel is a seasoned expert and Management Consultant in Regulatory Information Management with over 15 years of experience in the pharmaceutical industry. As a Regulatory Consulting Lead at MAIN5, he specializes in data governance, regulatory systems implementation, and cross-functional process optimization. Beyond compliance, his focus lies on unlocking the true value of an organization's data through initiatives like XEVMPD, IDMP, and SPOR. He ensures efficient and sustainable data quality by aligning people, cross-functional processes, and systems.
Raphael Sergent, ISO IDMP member & Pharma Solution Lead at Accurids
With 10 years of experience in the pharma industry, Raphael acquired the knowledge and business understanding of the domain. Active member of the TC215 WG6, he is involved in the establishment of the ISO IDMP International Standards and associated Technical Specifications. Raphael then joined Accurids in order to support international life-science companies to develop their FAIR principles and robust data models to face the challenges of the future (IDMP, PQ/CMC, SPOR, ESMP...) and adapt it to matrix environments and pluricultural teams.
This webinar is sponsored by Main5
Disclaimer: Whilst TOPRA is running this webinar for Main5, this is not an endorsement of Main5, Main5's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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