Regulatory Operations: Data Management

Offers a full range of services to provide a comprehensive support for data compliance for: Human medicines, Veterinary medicines and Medical devices.

Being a reference point for xEVMPD services, we are fully ready to support companies with: ISO IDMP, RIMS and DMS implementation.

Regulatory Operations: Data Management

Asphalion offers a full range of services to provide a comprehensive support for data compliance for:

  • Human medicines
  • Veterinary medicines
  • Medical devices

Being a reference point  for xEVMPD services, we are fully ready to support companies with:

  • ISO IDMP implementation
  • Regulatory Information Management System (RIMS) implementation
  • Document Management System  (DMS) implementation

 

Data Management Unit Services

Regulatory Operations: Data Management Solutions

At Asphalion we can give you support and help you navigate through the awareness process and work with you to be ISO IDMP compliant whether you have, need or can’t yet access a RIM system.

  • xEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicines Agency (EMA). It provides a standardized vocabulary for the Marketing Authorization of medicinal products.
  • Supporting xEVMPD submissions from the inception of the obligation, since July 1st, 2012.
  • Managing an average of 3500 xEVMPD petitions per year

 

Importance of 3rd Acknowledgement management in the context of data migration to PMS

⚠️ Managing EMA’s 3rd ACK is a crucial step in the context of migrating xEVMPD data into PMS, aimed at preventing and minimizing inconsistent data input into both the PMS database and eAF.

What is ISO IDMP?

  • The EMA is implementing the International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP).
  • The ISO IDMP standards specify the use of standardized definitions for identifying and describing medicinal products for human use.
  • The goals are to enhance clarity and efficiency in communications regarding medicinal product information in a robust and consistent manner.
  • ISO IDMP encompasses the entire lifecycle of medicinal products, including those in development, investigational stages, under evaluation, and already authorized. It offers a more comprehensive and detailed approach compared to xEVMPD. It is expected to be implemented starting from 2025 onwards.

 

How to implement ISO IDMP

 

ISO IDMP Implementation

 

Why choose ASPHALION for ISO IDMP implementation

  • Regulatory Expertise: Asphalion’s team has specialized knowledge in regulatory affairs, ensuring ISO IDMP compliance with current regulations.
  • Custom Implementation: We offer tailored strategies to meet the unique needs and challenges of each client’s product portfolio.
  • Technology Integration: Asphalion excels in integrating IDMP solutions with clients’ current systems, guaranteeing a smooth transition.
  • Proven Success: Asphalion has a demonstrated history of successful ISO IDMP implementations, supported by client testimonials and case studies.

 

If you need further information or wish to explore how we can assist you during this transition:

Contact us here!

What is a RIMS?

  • A Regulatory Information Management System (RIMS) facilitates the submission of both human and veterinary medicinal products to regulatory agencies for marketing authorization.
  • This invaluable software system aids in managing product dossiers and regulatory data, preparing submissions, and maintaining regulatory product information in the required formats.
  • Despite the widespread adoption of RIMS by pharmaceutical companies, many still rely on manual data entry. In the current landscape, it´s imperative for RIMS to be capable of directly transmitting data to the EMA.
  • Companies are now required to gather a larger volume of data at earlier stages, necessitating robust technological solutions to meet these demands.

 

What should an effective RIMS look like?

  • Enables to quickly and accurately identify product information requested by regulatory agencies
  • Collects product information under the eCTD specification
  • Takes into account the variation of products in the different agencies when creating a record
  • Correctly manages file changes and revisions, as well as product updates
  • Generates documentation subject to be submitted according to standards
  • Tracks all presentations and publications
  • Reduces times to issue submission to Regulatory agencies
  • Allows a clear monitoring from original submission during product life cycle
  • Adapts to company needs in terms of data volume and size to be managed
  • Complies with Regulatory requirements

 

Partners

RIMS implementation partners

 

WHY choose Asphalion for migration activities during RIMS implementation

  • Regulatory Information Expertise: Asphalion possesses deep expertise in managing regulatory information, ensuring that RIMS implementation aligns with global regulatory standards.
  • Streamlined Data Management: Our company provides solutions that streamline the management of regulatory data across the product lifecycle, enhancing efficiency and accuracy.
  • Customized Integration: Asphalion tailors RIMS integration to client-specific systems and processes, facilitating a smooth incorporation with minimal operational disruption.
  • Compliance Assurance: With a strong focus on compliance, Asphalion collaborates with vendors to ensures that the RIMS implementation meets all regional and international regulatory requirements.
  • Technology Leadership: Asphalion stays at the forefront of technological advancements, offering clients cutting-edge RIMS solutions that provide a competitive advantage

 

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What is PMS?

  • The Product Management Service (PMS) is a database that houses structured and consistent data on authorized products, adhering to established standards.
  • PMS assigns a unique identifier to each medicinal product.
  • The database will integrate master data from Substance, Organization and Referential Management Services.
  • PMS Data structure is ISO IDMP compliant.

 

Uniquely identification of medical products

PMS

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Why Asphalion?

xEVMPD Compliance

  • Over 10 years of experience since the inception of the Art. 57 obligation
  • We offer comprenhensive services, including bulk updates and products exports

RIMS Implementation Expertise

  • Diverse expertise in human and animal health products, including innovative, OTC and generics.

Leading ISO IDMP Transition

  • Our dedicated team ensures a smooth transition to ISO IDMP
  • Direct engagement with EMA, contributing to the EU Implementation Guide.
  • We provide end-to-end support, from initial awareness to hands-on data management.
Silvia Santos - Asphalion
Silvia Santos
Data Management Associate Director
“Asphalion is pleased to be an experienced service provider in the transition to data governance, covering our clients’ needs from xEVMPD submissions and SPOR management to transition to ISO IDMP, PMS verification and RIMS implementation”

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Beginning 15th September 2021
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