Leaflet digitalization in the European Union?

Photo by Danielle Rice - map of europe
Photo by Danielle Rice

If you follow us, you would remember an earlier article about changes in the pharmaceutical industry in the last years, around tools and technology for document management.

Was it an exponential change in the industry ?

Some examples of these changes are:

  • A paper archive/database
  • Tracing in an spreadsheet
  • Control of changes on paper
  • Email or Fax as project manager
  • Visual Artwork review
Photo by EMA

These types of processes are now a thing of the past, and are being replaced by Artwork Management systems, and proofing tools that take change management to a totally new level.

The change has been enormous and more changes could be needed due to agreements between the European Medicines Agency (EMA) , management at Medicine agencies (HMA) and the European commission projects from 2018, aiming at a digital transformation in sanitary support in the European Union (see the draft here: EMA)

This transformation has implications that are beyond my knowledge, but some of the phases that it entails were:

  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 2018 – collaboration between EMA-HMA-EC identifying the needs for a future digitalization.
  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 28 november 2018 – EMA runs a workshop with patients/consumers, health professionals, interested parties in the industry, academics, NGOs and regulators. This returned the key principles of this process.
  • February to July 2019 – public consultation with over 500 comments.

After reviewing these comments in relation to the key principles defined, a pilot program emerged in January 2022, aimed at evaluating the impact of the removal of the paper leaflets in a small portion of medicines for human use, within hospitals.

These medicines should include in their primary packaging a non serialised Data Matrix code that, once captured, would allow direct access to the digital version of the leaflet from the information allocated in CIMA.

Photo by Rodion Kutsaev

The pilot duration will be at least 2 years, and it will be implemented progressively.

Would there really be a digitalization in health assistance in the European Union? I believe that after all the effort, this will become a reality. The only question is to what extent is the EU capable of coordinating for the big change of digital times.

And you, are you ready?

Rafael Cruz Núñez
Artwork Manager

The Perfect Artwork Request / Briefing

Photo by afif-kusuma-RjqCk9MqhNg-unsplash

Depicts a dartboard with red darts on it
Photo by afif-kusuma-RjqCk9MqhNg

What is an Artwork Request/Briefing?

An Artwork Request is the start of the journey for a design agency. It contains the description of work that needs to be done on a design so that it meets all the necessary requirements to be ready to print and produce. This is applicable to both new designs and edits, and covers the process until it has gotten the sign off from all necessary departments and external parties.

Your design agency/studio needs a good request so that they can translate those requirements into a good artwork version.

Why is a perfect artwork request/briefing important?

  • It guarantees that you, as a client, get what you are expecting from your designs
  • It will reduce the number of back-and-forth iterations to complete the project
  • It assures that the chance of error is kept to a minimum
  • It makes turnaround times faster

Sounds simple. But in reality, it is not always so.

Why is that?

The reality is that many of the people making change requests do not create their information themselves, but they receive it from a third party (or sometimes even fourth). Frequently in a different language.

Furthermore, the level of understanding and knowledge about design/printing specifics of everybody involved in the artwork process varies a lot: across organisations, across different roles, across countries. It is literally impossible to expect that every single person involved knows the same, and that they are good at translating that information into an actionable instruction.

When that happens, and not enough/clear information is provided, it is very easy to fall into a trend that leads to extra time to ask questions and get answers, and to obtain and provide the right details (measurements, keylines, logos, images…).

What is then the perfect request?

The perfect request is one that describes the changes required in a way that makes the outcome anticipated clear and agreed on by both the requestor and the executor, but also other parties that may need to get involved later (e.g. manufacturer).

The perfect request should cover 5 main areas:

  1. Product guidelines – becoming familiar with the client’s guidelines is a pre. All designs must follow these, so they become a hidden requirement after the first iterations with a customer, but nonetheless, a very important item to request at the beginning or refer to.
  2. (Manufacturing) technical requirements – any printer/manufacturer requirements are important to understand so that the artworks are not sent back for adjustments at the last step of the process.
  3. Key data – including the text, changes to this, and graphics that the artwork needs to include and any earlier mockups or open artworks that may exist.
  4. Keylines – attach these always to a request, as using a wrong one will require big changes to your artwork versions.
  5. Format specifications – dimensions and other details about the artwork.

Obtaining this information may require interaction between different departments. It may be best to ask the experts on each area to pitch in to your request so that you get the right information in one go. Also important to have one system where to collate it all, rather than letting it fly through emails and attachments. But we can talk about that another time!

The important thing is to establish a great collaboration between your design agency and your quality and/or regulatory teams. They, together, need to manage the workflow process in a way that brings an artwork from request to execution with the least amount of changes and time to market.

And this collaboration starts with defining what is for your company a perfect starting point, using the above criteria, and what information needs to be provided and by whom at the start of the process.

Do you already know what YOUR perfect request looks like?

Share with us your perfect briefings via: marketing@twonas.com!

Zuriñe García
Marketing