What is NIS2?
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, 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.