Paolo Tomasi EMA

Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose. For more information, see for example Applied Sciences | Free Full-Text | Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps.

IRIS Industry Users should note that uploading a Letter of Authorization is not required in IRIS for Paediatric submissions (or for Scientific Advice, PRIME, Orphan, or ITF submissions), since the portal already performs authentication of the user at login. In addition, there is no need to create and upload also the old Part A PDF form, since the information required is already included in the webforms of the IRIS Industry Portal, or to upload previous EMA paediatric decisions for the same product. 
EMA aims at improving and simplifying submissions for scientific procedures via the IRIS portal. 

In IRIS each submission for a Paediatric Investigation Plan or a Product-specific Waiver must specify a single condition. For example, if a PIPs is required for two separate conditions (not indications in the same condition), then two separate submissions are required, one for each condition, and separate Regulatory Entitlements will be generated by IRIS after a positive decision.  

This is due to legal and technical reasons, among which the following are of particular relevance: 

1. Regulatory entitlements for development-related procedures in IRIS are linked to a single condition, as for Scientific Advice and Orphan Designations.

2. Art. 14 of the Paediatric Regulation requires EMA to publish a list of the waivers granted, which is not possible if a Regulatory entitlement contains several conditions, for some of which a PIP may be granted and for others a Product-specific waiver is granted. Regulatory entitlements for paediatric applications are thus of two categories, Paediatric Investigation Plan (with or without deferrals or partial waivers) and Product-specific waiver.  

3. Experience with the past system and database has shown that it is more convenient for applicants to have separate PIP decisions for different conditions, to prevent the "never-ending PIP" issue and to be able to claim the reward after completion of development in a single condition (i.e. after completing the "reward PIP"). For additional information on this, please see EMA policy on changes in scope of PIP decisions (europa.eu).

Each submission should contain all the relevant information and documents. It is of course possible to re-upload the same document(s) several times, and copy paste the same data sections for more than one application, whenever the applicant believes this to be appropriate. In IRIS, it is possible to open multiple instances of the IRIS portal in different browser tabs, at the same time, and create separate submissions in parallel. 

Key Elements should be submitted in the IRIS platform as per current procedural guidance. 

At present, the "Application form" generated by IRIS when clicking on the button in the submission form, or when the application is actually submitted after completion, includes a table of proposed studies and measures that contains a selected subset of the key elements. A User story to change the application form so that all key elements are included has been added to the IRIS backlog (193557 - Improve the "Application form" document for Initial PIPs, Modification, PSW and Compliance check [all structured data to be included in the document]).
Possible workarounds are to paste the key elements into IRIS from an existing document, or to take screenshots of the webforms, or even to use a web scraping algorithm or software. 

A contact person is assigned for most paediatric regulatory entitlements (PIPs or waivers granted) and is visible to the IRIS Industry users who are affiliated to the organization, only in the IRIS Industry portal. This contact person can usually be reassigned to another IRIS manager associated to that organisation. However, due to a glitch in the synchronization between OMS, IAM and IRIS, newer locations of a pre-existing parent organization are not associated automatically to all the users who are affiliated to the parent organization. As the popup list shows only users affiliated to the location that owns the Regulatory Entitlement, it may contain a reduced number of individuals, or none at all. EMA is aware of the issue and a fix is under development; meanwhile, a potential workaround is transfer the RE to another location of the same parent organization, such as the legal seat or an older location, where more users are associated. 

Please note that the contact person for a regulatory entitlement is not published, and is only stored in case EMA needs to contact the RE holder outside of an ongoing procedure. Consequently, there is no obligation for Industry to ensure that information is updated frequently.

On the other hand, the contact email and telephone number for interested parties are not affected by the described glitch; since EMA plans to make that information public in the IRIS Paediatric Register in the near future, it is important to maintain the information in those two fields updated.  

The IRIS system by default limits the size of individual files uploaded as part of an application to 50 Mb. Almost all text and PDF files can be reduced to a size within this limit through the use of appropriate techniques, some of which are reported below. Zip files should not be used, except for references (which can also, preferably, be sent as a single combined PDF file). 

For Word Documents:

1. Compress Images:

   • Go to File > Options > Advanced.
   • Scroll down to the "Image Size and Quality" section.
   • Uncheck the box for "Do not compress images in file" and select a lower resolution, such as 150ppi, in the field below.
      

2. Save As Different Format:

   • Save the document as a .docx file instead of .doc. The .docx format is more efficient in terms of file size.
      

3. Remove Unused Styles and Formatting:

   • Go to Home > Styles.
   • Clean up unused styles by right-clicking and deleting them.
      

4. Embed Fonts Efficiently:

   • Go to File > Options > Save.
   • Under "Preserve fidelity when sharing this document," check the box for "Embed fonts in the file" but uncheck "Embed all characters" and "Do not embed common system fonts."

For PDF Documents:

1. Optimize PDF Using Adobe Acrobat:

   • Open the PDF in Adobe Acrobat Pro.
   • Go to File > Save As Other > Optimized PDF.
   • Use the settings to compress images, discard unnecessary objects, and streamline the document structure.
      

2. Reduce PDF Size Online:

   • Use online tools like Smallpdf, ILovePDF, or PDF Compressor to reduce file size.
      

3. Save As Reduced Size PDF:

   • Open the PDF in Adobe Acrobat.
   • Go to File > Save As Other > Reduced Size PDF.
      

4. Remove Unnecessary Objects:

   • Use the "Edit PDF" tool in Adobe Acrobat to remove any unnecessary images, text, or other objects.

Additional Tips for Both Formats:

• Remove Metadata: Removing metadata and document properties can reduce file size.
• Use External Tools: Use tools like Microsoft Word's "Compress Media" feature for videos or third-party software designed for file compression.
• Split Document: If the document is still too large, consider splitting it into multiple smaller documents.

Draft submissions should not be deleted. They are part of the procedure and are necessary. As mentioned in the notice, no action is required or necessary. Draft submissions will be changed to "completed" at the end of the migration process. 

Please see Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures · IRIS (europa.eu)

During the migration of old, closed paediatric procedures from EMA's previous system into IRIS, the standard submission receipt notification has been erroneously sent to the case contact person by an automated workflow. This has affected more than 5000 cases. 
Please ignore any submission receipt email for Paediatric cases with a case title starting with "EMEA-", as these are the migrated cases. There is no need to reply to the email or to undertake any action. 
We apologise for any confusion induced, and we thank you for your understanding.