IDMP PREcollector Service Package
Preparing your organization ready for the move to IDMP
The transition from XEVMPD to IDMP is significant. IDMP requires the collection of a much broader set of data than XEVMPD or other similar standards. It includes things such as medicinal products, pharmaceutical products, clinical particulars, substance information, packaging, manufacturing and marketing authorizations. This information comes from various systems and groups within your organization including: product development, regulatory affairs, manufacturing, and drug safety.
With so many things to consider, the question is where to start?
Preparing your existing data for IDMP
At EXTEDO we understand the finer details of the new IDMP requirements, in fact several our lead consultants were involved in the definition of the standard itself. Our team of technical and regulatory consultants can provide you with an in-depth analysis of your existing processes and technologies and create an accurate assessment of the changes your organization needs to make to ensure IDMP compliance.
An important service EXTEDO offers in this process is our IDMP PREcollector Service Package. It is designed to help organizations of all types to understand the data required by the IDMP standard.
The IDMP PREcollector Service Package covers the entire IDMP standard and is adapted to the needs of each customer. The result of the IDMP PREcollector service is an Excel template that enables the user to pre-collect all required IDMP data. But it is more than just a template, it is a bundle of services including training and consulting to guide your organization through the early stages of IDMP preparation and planning.
Supporting you through your first steps
Presented by one of EXTEDO’s leading IDMP experts, an initial workshop and day of training will ensure that your staff understands the IDMP standard and its implications on your business. We will also review your requirements relating to the specification, including details of the data that needs to be captured and stored.
Having gained a full understanding of your requirements, we will work with your team on the configuration and completion of the PREcollector spreadsheet. After final creation of your IDMP PREcollector spreadsheet we will provide detailed IDMP training for your staff, enabling your team to fill in the spreadsheet with all required data to remain Art. 57 compliant for now and for the future and to be ready for any IDMP adventures that will come along our path.
Gap Analysis and Prefill with XEVMPD Data
Through a series of on-site workshops, we will help you to identify where data currently exists and where there are holes in your current data capture processes that need to be addressed in preparation for IDMP. With our knowledge of the standards and your knowledge of your business, we will ensure that no stone goes unturned. Using our internal tools, EXTEDO is able to extract a large part of the mandatory IDMP data from your existing XEVMPD data directly from EVWEB. We will then import this into the PREcollector spreadsheet. Through cooperation with our Partners we are also able to automatically extract data directly from SmPCs and add them to the IDMP PREcollector spreadsheet. This saves you the time associated with having to fill in mandatory IDMP data manually.
Looking forward, our goal is to enable you to extract all the data you have collected within the IDMP PREcollector spreadsheet in SPL format and directly import it to MPDmanager. With all the necessary IDMP data in MPDmanager, the tool allows you submit it directly to the authorities. With EXTEDO by your side means, you no longer have to worry about the upcoming IDMP changes anymore.
- learn about the IDMP migration process
- reduce time and resources associated with the transition from XEVMPD to IDMP
- understand the efforts involved in migrating your data to IDMP
- ensure effective IDMP data planning
- start IDMP data collection now in a lean and efficient way
Get ready for IDMP now
As the partner of choice to over 35 regulatory authorities around the world, EXTEDO’s services team is well-equipped with the knowledge and experience to help your organization transition painlessly from XEVMPD to IDMP.
If you would like to start a discussion and learn more about our solutions for accelerating IDMP compliance within your company, contact one of our specialists at firstname.lastname@example.org.