What is NIS2?

In this blog post, or Pharma IT Insight, we describe the EU's new NIS2 Directive including the life science companies that are now in scope

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.

AI in Pharma: Commercial Use Cases

Banner image displaying the title of a blog post concerning the use of AI in the pharma industry with a particular focus on commercial use cases.

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.

CMC vs GMP: What’s the difference?

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

5 Microsoft Word Hacks for Regulatory Writing 

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.

Equipment Qualification in Pharma

Displays the title of the Pharma IT Insight as well as a background image showing an example of Pharmaceutical Manufacturing Equipment that could be validated.

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 in Pharma with Martin Rother Breyen

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!

3 Key Take Aways from the New GAMP5 Second Edition

Banner Image showing a snapshot of the crowd and Sion Wyn, Editor of the GAMP5 Second Edition at an event hosted by the Pharma IT Academy

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.​