READY! for ePI
READY! for ePI is the first commercially available solution that enables pharmaceutical companies and regulators to create ePI by using our state-of-the-art IT technology with the help of Artificial Intelligence.
The solution enables the industry and the regulators to start with the preparation and migration activities. For the purpose of handling ePI, we have pre-configured our READY! platform to meet the specific demands of recognition, import, indexing, authoring, quality check, lifecycle management, and submissions of ePI documents in XML format. The use of Artificial Intelligence makes the process faster and improves the accuracy of the migrated documents.
What is ePI (electronic Product Information)?
ePI is authorised, statutory product information for EU medicines in a semi-structured electronic format using the EU Common Standard.
The ePI standard comprises:
- Package leaflet (PL) – for patients/consumers.
- SmPC – intended for healthcare professionals.
- Labelling – outer and inner packaging information.
The adoption of ePI could make access to product information easier for both healthcare professionals and patients.
The EU ePI Common Standard refers to the technical features of ePI agreed to by regulators and stakeholders.
The standard is based on FHIR, on open international data exchange standard for healthcare information. It makes it easy and quick to build healthcare applications and to exchange data.
ePI is adapted for electronic handling and allows dissemination via the web, e-platforms, mobile devices, and print.
More information: EU Common Standard for electronic product information (ePI).
READY! for ePI comprises:
DiCE XML Editor
The specific implementation of DiCE is designed to meet the requirements of subject matter experts to quickly author ePI and SPL documents.
READY! – A Product Lifecycle and Document Management System
We have preconfigured our READY! platform for the purpose of handling ePI.
ePI Document Templates
Our preconfigured process templates are based on QRD templates and cover the complete management of document in all phases of the lifecycle.
Artificial Intelligence services
We are integrating Artificial Intelligence services for automatic document recognition, identification, data extraction, indexing, and quality control of PI documents.
READY! ePI FHIR Gateway
The FHIR standard is well-defined, and it is easy to implement the gateway to implement the automatic upload of the ePI documents as soon as the EMA makes this feasible.
Nanokinetik®, ready4ePI® and DICE® are registered trademarks of Nanokinetik.
Why should you care?
To prepare, submit, and maintain documents in ePI, the industry will have to:
- Identify and collect approved and effective versions of existing valid PI documents,
- Transform existing valid documents into new XML format using new tools,
- Create new documents in XML using new tools,
- Check all documents and their translations,
- Submit documents to the authorities using new IT technology,
- Keep track of regulatory status of the documents,
- Keep record of the documents in electronic format,
- Maintain changes and new versions of the documents,
- Manage lifecycle of the documents in electronic format,
- Track approved and effective status of ePI documents,
- Keep links between translations of same documents,
- Link documents to the related medicinal products,
- Reuse documents in other systems (integrations), and
- Integrate documents with digital sources in IDMP/SPOR format.
Why should you care?
To prepare, submit, and maintain documents in ePI, the industry will have to:
- Identify and collect approved and effective versions of existing valid PI documents,
- Transform existing valid documents into new XML format using new tools,
- Create new documents in XML using new tools,
- Check all documents and their translations,
- Submit documents to the authorities using new IT technology,
- Keep track of regulatory status of the documents,
- Keep record of the documents in electronic format,
- Maintain changes and new versions of the documents,
- Manage lifecycle of the documents in electronic format,
- Track approved and effective status of ePI documents,
- Keep links between translations of same documents,
- Link documents to the related medicinal products,
- Reuse documents in other systems (integrations), and
- Integrate documents with digital sources in IDMP/SPOR format.
Why should you care?
To prepare, submit, and maintain documents in ePI, the industry will have to:
- Identify and collect approved and effective versions of existing valid PI documents,
- Transform existing valid documents into new XML format using new tools,
- Create new documents in XML using new tools,
- Check all documents and their translations,
- Submit documents to the authorities using new IT technology,
- Keep track of regulatory status of the documents,
- Keep record of the documents in electronic format,
- Maintain changes and new versions of the documents,
- Manage lifecycle of the documents in electronic format,
- Track approved and effective status of ePI documents,
- Keep links between translations of same documents,
- Link documents to the related medicinal products,
- Reuse documents in other systems (integrations), and
- Integrate documents with digital sources in IDMP/SPOR format.
EMA ePI Authoring tool
The EMA will make an authoring tool available that will help small companies to create their ePI information online. However, this is not a solution for large and medium-sized companies. For this purpose we have developed our own XML editor – DiCE.
What is the challenge for large and medium-sized companies?
The problem the industry faces first is how to find, collect, and analyse existing PI documents and where to store this information.
The industry will have to collect, analyse, create, and check millions of PI documents in many languages. Most of these final and approved versions of documents are currently in paper or scanned PDF and image formats.
The second problem is to rewrite all of the documents using new XML tools. Traditional document authoring tools such as Microsoft Word will be obsolete.
Finally, the industry will have to maintain the lifecycle and approval process of these electronic documents in a validated environment.
Approved and effective PI documents in ePI format will have to be uploaded to the EMA using the FHIR gateway, a new technology.
After the upload, the maintenance of the documents including new version will have to be facilitated, like the management of Article 57 data.
Contact Us for more details and a live demo.
Nanokinetik Ltd
2 Leman Street
E1W 9US London, UK
info@nanokinetik.com
www.nanokinetik.com
For more than 15 years, our sole focus has been the design, implementation, and validation of innovative software solutions for the pharmaceutical industry.
