Pharma

Embracing the future of document authoring in pharma: a structured and data-driven approach

In the fast-paced world of pharmaceuticals, the clarity and precision of documentation are not just a matter of compliance, but a cornerstone of innovation and patient safety. Structured content plays a critical role in meeting the stringent regulatory demands and the quest for efficiency. The shift towards structured content authoring is revolutionizing the way we […]

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Understanding structured content: definition and benefits

In today’s digital age, the way we manage and utilize information has evolved dramatically. Conventionally, document content is unstructured, with text, figures, and tables that authors can freely arrange in the way they want to. By structuring content, we can shift from a document-based to a content and data-based approach. But what exactly is structured

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Standardize and Harmonize Product Information with Fonto: Advancing the ePI Initiative

In the ever-evolving landscape of pharmaceutical regulations and information management, the need to standardize and harmonize product information has become increasingly crucial. At the forefront of this movement is the Swedish Medical Products Agency, Läkemedelsverket, which has recently made significant strides with their ePI (electronic Product Information) Proof of Concept. In this post, we’re sharing

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Update on national pilot study for pharmaceutical companies creating ePI

In 2022, the Swedish Medical Products Agency (Swedish MPA) selected Fonto as the editor of choice for the creation of electronic structured SmPC’s. Over the past few months, the Swedish MPA has developed an XML template adapted for Fonto. Electronic product information In a Proof-of-Concept model, information elements are divided into categories depending on the

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Swedish Medical Products Agency selects Fonto

Hurra! Fonto has been selected as the XML editor of choice by the Swedish Medical Products Agency (Swedish MPA) for a national pilot study for pharmaceutical companies creating ePI.  Electronic Product Information (ePI) ePI refers to the authorized, statutory product information for medicines (including the Summary of Product Characteristics, Package leaflet and labelling) adapted for

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Structured content for pharma

It takes pharma companies about five times longer to create content, compared to other industries. Delayed drug approvals turn into an average loss of $1 million dollars per day for pharma companies. Val Swisher and Regina Lynn Preciado from Content Rules recently published an interesting e-book: “Structured Content for Pharma – Making the Case for

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Moving from Word: why changing the interface is unacceptable

In pharma—and many other industries, too—Microsoft Word is the tool to create content. It’s the natural environment for many subject-matter experts to write, edit and review content. Every author is familiar with the Word interface. But it’s not structured content that’s created … “We cannot change the authoring experience” Forcing subject-matter experts, for example medical

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Global Pharmaceutical Regulatory Affairs Summit: Structured Content and Integrated Data

Today, Jan Benedictus presented at the Global Pharmaceutical Regulatory Affairs Summit 2022 in Berlin: “The Future of Documents: Structured Content, Integrated Data”. Global Pharmaceutical Regulatory Affairs Summit The Global Pharmaceutical Regulatory Affairs Summit focuses on the challenges of IDMP, RIM, eSubmissions and Global Market Regulation in the pharmaceutical industry. The Future of Documents The Future

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"Highly regulated industries such as finance and life sciences, should be the next target for structured content"

In December 2020 Forrester published a report that strongly confirmed our thoughts, and the developments we see in our market(s): The Future Of Documents: A Look Beyond The Paradigm Of Paper And Into Opportunities For Innovation – Forrester 2020. Based upon this report, we’ve interviewed thought leaders about the future of documents. In this article,

"Highly regulated industries such as finance and life sciences, should be the next target for structured content" Read More »

"Data is the heart of the business, whereas documents are the “packaging” with the intent to create the context of the data in the associated processes"

In December 2020 Forrester published a report that strongly confirmed our thoughts, and the developments we see in our market(s): The Future Of Documents: A Look Beyond The Paradigm Of Paper And Into Opportunities For Innovation – Forrester 2020. Based upon this report, we’ve interviewed thought leaders about the future of documents. In this article,

"Data is the heart of the business, whereas documents are the “packaging” with the intent to create the context of the data in the associated processes" Read More »

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