Pharma IT Insights

Pharma IT Insights

Pharma IT provides insights on IT Applications, Medical Devices, Drug Development, and more. All of our insights are based on the latest knowledge within Pharma, Biotech, and IT - and all insights are written by our consultants.


Featured Insight

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.

Latest Insights

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


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.

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.


AI in Pharma: 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.

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 in Pharma

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!


Increased disclosure of clinical trial documents following the EU Clinical Trials Regulation (CTR)

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.


Choosing the Right Expression System for Heterologous Protein Production

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.

An image of a clinical scientist in a lab setting, overlaid with the text "5 Considerations for Ensuring EU CTR Readiness"


Top 5 Considerations for Ensuring CTR Readiness

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.


Automated Testing of IT Systems in GxP environments with Selenium

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.

Importance of European Pharmacopeia Monitoring for GMP Compliance


Importance of European Pharmacopeia Monitoring for Lab GMP Compliance

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.


Pharmacovigilance During COVID-19

Pharma IT Consultant Sara Hamilton discusses the important highlights of two reports published in late 2021 which are relevant and informative for improving compliance in pharmacovigilance.


News

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


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.


Read More →

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.


AI in Pharma: 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.


Read More →

Are you looking for more expert knowledge on pharma and biotech?

Pharma IT provides highly experienced consultants for the Pharma, Biotech, and Medical Device Industries

Are you looking for more expert knowledge on pharma and biotech?

Pharma IT provides highly experienced consultants for the Pharma, Biotech, and Medical Device Industries