Pharma IT Insights

This Insight explores the impact of EcoVadis Ratings on procurement decisions in the life sciences. Director of Sustainability, Communications, and Culture @Naomi Jade Kellogg breaks down why EcoVadis matters, how it’s shaping procurement, and what suppliers can do to boost their ratings and stay ahead.

Pharma IT Insights Drug-Device Combination Products and the Impact of the EU MDR By Anne Louise Kirkegaard February 9, 2025 Pharma IT Insights Drug-Device Combination

This Insight is part of our AI in Pharma Series, where we share use cases for AI & automation in a highly regulated reality. With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated AI solution to solve them.

This Insight, written by Pharma IT Director of Regulatory Affairs (RA) Anne Louise Kirkegaard, highlights the importance of a solid RA strategy for small pharma and biotech companies. Plus tips to ensure market success and compliance.

This Insight, written by Pharma IT Cybersecurity expert Steen Lindebjerg provides a high level overview of the EU’s NIS2 Directive, including key changes in the old NIS legsilation and steps to take towards compliance.

This Insight is part of our AI in Pharma Series, where we share use cases for AI in a highly regulated reality. Pharma IT’s Director of Commercial & Medical Consulting discusses the use of AI in the commercial stage of the pharmaceutical life cycle. This includes use cases in promotional content ideation, creation, review, and approval.

This Insight describes the 3 main types of automation being used to increase the efficiency of pharmacovigilance and safety case processing! Learn about RBA, RPA, and AI.

This Insight describes the similarities and differences between CMC and GMP. Both are crucial to guarantee drug product quality, safety, and consistency.

Microsoft Word is a widely utilized tool for creating and editing regulatory documents. However, its full potential is often overlooked. In this Insight, Principal Medical Writer Katja Heinemeier provides 5 Microsoft Word Hacks for regulatory writers to increase writing speed & efficiency.

In this Insight, Jakob Juul Rasmussen highlights the recently released EMA Guideline on computerised systems and electronic data in clinical trials. The Insight includes a high-level overview of what’s included in the new guidance and background context for its adoption.

Equipment Qualification is critical in the pharmaceutical industry. In this Pharma IT Insight, Rojan Demirtas provides a high-level description of the equipment qualification process, the expertise required to do it successfully, and the biggest challenge facing the life sciences industry’s ability to do so.

Omnichannel Marketing is a key trend within the commercial pharma space. For this Insight, we sat down with Director of Commercial & Medical Systems, Martin Rother Breyen, to learn more about what it is, why it matters, and how to use it!

The Pharma IT Academy recently hosted Sion Wyn for an exclusive event highlighting the new GAMP5 Second Edition. In this Insight, we recap the event and provide 3 Key Takeaways.​

The Pharma IT Academy recently hosted Sion Wyn for an exclusive event highlighting the new GAMP5 Second Edition. In this Insight, we recap the event and provide 3 Key Takeaways.​

From January 31st, 2023, it will be mandatory to use Clinical Trials Information System (CTIS) for the submission of clinical trial applications (CTAs) and for documents related to the maintenance of the clinical trial authorisation for clinical trials in Europe. In this insight, Principal Consultant Lena Brahe briefly describes the CTIS, and then focuses on the Investigator’s Brochure and explains the implications sponsors should be aware of following the requirement for public disclosure of information submitted to CTIS.

Martin Willer provides a guide to choosing the right expression system for heterologous protein production. Every expression system comes with a unique profile of strengths and weaknesses that should be considered, including both qualitative and quantitative parameters. This includes the factors you should consider and why it is important to plan your documentation process from the very start.

The EU’s new Clinical Trials Regulation (CTR) is now live! This Insight briefly describes the purpose of the new regulation and shares 5 important considerations for clinical trial sponors.

Testing and validation are a central component of ensuring the security and continuity of computerized systems. For this reason, automation of testing efforts is an important aspect of an overall automation strategy. This Insight outlines the benefits of test automation and discusses how Selenium can be used to automate processes, like regression tests in Veeva, which have traditionally been done manually.

DevOps has become a bit of a buzzword, its use in practice is often too vague. To demystify the topic, this Insight examines DevOps from a technical perspective. By viewing the concept through the lens of Cloud Computing and Infrastructure as Code (IaC), a fuzzy DevOps concept becomes much more clear.

Ensuring compliance with the European Pharmacopeia (Ph. Eur.) is a cornerstone of European GMP compliance. This Insight highlights the importance of monitor coming changes in the pharmacopeias, and highlights the latest revised general monograph 2.2.46 Chromatographic Separation Techniques.