WeeklyTalk #147
IT for the pharmaceutical industry: More than just bits and bytes
In this episode, we focus on the specialized field of pharmaceutical IT.
In this episode we will focus on the special topic of pharmaceutical IT. We will discuss how customized IT solutions enable and secure the development, manufacture, and monitoring of drugs. What exactly does the term pharmaceutical IT mean, and how does it differ from IT in other industries? What role do regulatory requirements such as GxP compliance play in this context?
Chapter Tokens
00:00:00 - Introduction: Pharmaceutical IT vs. Life Sciences
00:01:07 - Historical overview: From Höchst AG to today
00:01:55 - Special features of the industry: Patient safety and high R&D investments
00:02:42 - Networked IT: Data flow from research to production
00:04:14 - Regulatory requirements: GXP guidelines and the influence of the FDA and EMA
00:05:55 - Validated systems and change management
00:07:48 - Cloud updates, agile methods, and GAMP 5.2
00:10:11 - Risks, audits, and production stoppages
00:11:38 - Specialists vs. generalists: The importance of process understanding
00:12:08 - "Markus, I don't have to explain to you what pharmacovigilance is."
00:13:31 - Project example: Outsourcing clinical research to CROs
00:15:21 - Center of Excellence: Low-code platforms in the GXP environment
00:17:35 - Future trends: AI in drug discovery and simulation
00:20:37 - Standards, cybersecurity (IEC 81001), and certifications
Note on Operation: A single click on the play icon activates both the interactive chapter navigation and the sound of the video.
November 06, 2025