E3: xEVMPD Maintenance with Donika Doda

This video provides an in-depth exploration of xEVMPD (Extended Eudravigilance Medicinal Product Dictionary) maintenance, a critical regulatory compliance requirement for pharmaceutical companies operating within the European Union. Donika Doda, a Regulatory Affairs Specialist, discusses the complexities and strategies involved in making appropriate data submissions to the European Medicines Agency (EMA). The discussion highlights xEVMPD's role as the "mother of EMA databases," established in 2012 as part of Pharmacovigilance Legislation, serving as a central dictionary for medicinal product information and an interface for adverse event reporting.

The conversation delves into the practicalities of xEVMPD maintenance, particularly how it fits into the post-approval phase of variation management. When a variation, such as a change to a Summary of Product Characteristics (SPC) or leaflet, is approved and impacts xEVMPD, companies are mandated to submit updated data to Eudravigilance within strict timelines (typically 15 or 30 days). Donika describes a largely manual process where Regulatory Affairs teams receive approved labeling, communicate the change, and then a designated person manually enters the database, finds the correct product, performs the update, and sends it to the EMA, awaiting an acknowledgment message. This manual process is underscored as a legal compliance obligation, crucial for ensuring healthcare professionals have access to the most current and accurate information, especially concerning safety variations.

A significant portion of the discussion focuses on the challenges associated with xEVMPD maintenance. These include the inherent complexity of manual data entry, the need for precise timing, and the organizational hurdles arising from involving multiple departments like Pharmacovigilance and Regulatory Affairs. Donika emphasizes that the number of steps in the process directly impacts efficiency, advocating for streamlined workflows. A major pain point identified is the pervasive data duplication across various departmental software systems that often "do not talk to each other," leading to inefficiencies and wasted resources. This fragmentation necessitates a broader industry shift towards digital transformation.

Looking to the future, the video introduces IDMP (Identification of Medicinal Products) as the "big brother" to xEVMPD, representing a significant opportunity for the industry to enhance efficiency and collaboration. IDMP is anticipated to facilitate a real interface between company software systems and the EMA, drastically reducing the time and effort required for data communication and maintenance. This upcoming standard is seen as a catalyst for companies to align their data, foster inter-departmental collaboration, and reduce duplication. The speakers advocate for companies to embrace this digital transformation, potentially by establishing dedicated teams responsible for managing this transition, ultimately leading to quicker access to reliable information for patients, healthcare professionals, and more efficient assessment processes for regulators.

Key Takeaways:

• xEVMPD as a Core Regulatory Database: The Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) serves as the foundational "mother of EMA databases," centralizing medicinal product information and linking to pharmacovigilance for adverse event reporting.
• Mandatory Compliance for EU Operations: Since 2012, xEVMPD maintenance has been a mandatory legal compliance requirement for all pharmaceutical companies with products registered in the European Union.
• Manual and Time-Sensitive Update Process: Following the approval of variations (e.g., changes to SPC or leaflets), companies must manually update xEVMPD data within strict deadlines (15 or 30 days), involving regulatory affairs teams and direct communication with the EMA.
• Critical for Patient Safety and Healthcare Professionals: Maintaining an up-to-date xEVMPD database is vital for patient safety, as healthcare professionals rely on this information from their respective authorities to ensure they have the latest details on prescribed or used products, especially for safety variations.
• Challenges of Inter-Departmental Complexity: The maintenance process is complicated by involving multiple departments, such as Pharmacovigilance and Regulatory Affairs, highlighting the need for clear roles, responsibilities, and efficient communication channels.
• Inefficiencies Due to Data Duplication and Disparate Systems: A significant challenge is the widespread duplication of information across different departmental software systems that lack interoperability, leading to wasted resources and increased effort.
• IDMP as a Catalyst for Digital Transformation: The upcoming IDMP (Identification of Medicinal Products) standard is viewed as a major opportunity to drive digital transformation, promising a real interface between company software and the EMA, thereby reducing communication and maintenance times.
• Opportunity for Streamlined Operations and Collaboration: IDMP implementation encourages companies to align data, foster greater collaboration between departments, and reduce data duplication, leading to more efficient internal operations.
• Need for Dedicated Digital Transformation Teams: Companies are advised to consider establishing dedicated teams responsible for managing digital transformation initiatives to ensure a cohesive approach and successful adoption of new technologies and regulatory standards.
• Benefits of Digital Adoption: Embracing digital transformation and implementing connectors between systems will reduce timing and effort, improve data reliability, and ultimately lead to quicker access to information for patients and healthcare professionals, as well as more efficient regulatory assessments.

Key Concepts:

• xEVMPD (Extended Eudravigilance Medicinal Product Dictionary): A mandatory EMA database containing information on all medicinal products registered in the European Union, serving as a central dictionary and linked to pharmacovigilance.
• Eudravigilance: The European Medicines Agency's (EMA) system for managing and analyzing information on suspected adverse reactions to medicines authorized in the European Economic Area (EEA).
• EMA (European Medicines Agency): The agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union.
• Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
• IDMP (Identification of Medicinal Products): A set of ISO standards for the unique identification of medicinal products, aimed at standardizing the way medicines are identified and described globally.
• SPC (Summary of Product Characteristics): A document that describes the properties and the approved conditions of use of a medicinal product.
• Leaflet: The patient information leaflet (PIL) that comes with a medicine, providing information on how to use it safely and effectively.
• Variation Management: The process of managing changes to a medicinal product's marketing authorization after it has been approved.

Tools/Resources Mentioned:

• Eudravigilance: The database to which xEVMPD updates are submitted.
• Vault: Mentioned as a potential platform where connectors might be built for future integration.