Keynote · Agentic AI for pharma & life sciences
Keynote on AI in pharma: agentic AI and GMP
How can autonomous AI agents meet the strict requirements of Good Manufacturing Practice – and who is liable if they don't? Sadia De Kiden gives leaders in pharma and biotech clear answers.
The issue
When AI takes part in GMP decisions
In pharma, what is not documented did not happen. That is exactly what makes AI agents a challenge. They work fast and flexibly – but in a GMP environment they must remain traceable, validated and controllable.
EU GMP guidelines require validation, data integrity and clear responsibilities for computerised systems (Annex 11). The qualified person remains responsible for batch release – however much groundwork an AI does. With the new Annex 22 on artificial intelligence, currently a draft, the EU plans its first GMP rules specific to AI: critical applications are to use only static, validated models, and generative AI only non-critical tasks under human oversight. In addition, there are the EU AI Act and the new Product Liability Directive, which covers software from December 2026.
This keynote on AI in pharma turns the rules into leadership questions: where may an agent act, where is a human needed, and how do you demonstrate that during an inspection?
Key messages
What your audience takes away
Agents need boundaries
An AI agent in a GMP environment needs a defined scope, approvals and an audit trail – otherwise it will not stand up to inspection.
Liability cannot be delegated
Responsibility for quality and patient safety stays within the company. The keynote shows exactly where it sits.
Compliance as an advantage
Those who validate and document AI properly can deploy it faster and more safely than their competitors.
Content
Questions the keynote answers
What is agentic AI?
The difference between an assistant that suggests and an agent that acts.
GMP meets AI
Validation, data integrity, audit trail and the planned Annex 22: which principles apply to AI agents.
Who is liable when things go wrong?
Provider, deployer, qualified person, management – how responsibility is distributed.
The path to safe deployment
Questions for leaders before the first agent goes into production, quality or pharmacovigilance.
The keynote is tailored to your audience in advance – from quality assurance to the board.
Why Sadia De Kiden
Medical law meets artificial intelligence
Sadia De Kiden is a lawyer with an LL.M. in medical law and has worked in healthcare for 20 years. She advises practices and pharma and combines regulatory knowledge with the view of an entrepreneur who is responsible for people and processes herself.
- LawLawyer: studied law at LMU Munich, LL.B. from the University of London and three LL.M. degrees, including medical law and human rights law
- Healthcare20 years of practice in healthcare, advising medical practices and pharma
- EntrepreneurLeads 26 employees at SdK Dental & Medical Services and has run companies with more than 30 staff
- AwardsImpact Icon Award 2026 – top 3 (SHEconomy & herCAREER), Phönix Prize of the City of Munich
- MediaBR documentary “Lebenslinien”, Bayern 2 / ARD Sounds podcast, SAT.1 breakfast TV
- StageHas spoken for UN Women (Dubai, Mauritius), at herCAREER Munich and at Heartseeds & Mic Dropz in Luxembourg
FAQ
Frequently asked questions
How long is the keynote?
The keynote on agentic AI and GMP runs 45 to 60 minutes. For internal events there is a 30 to 50-minute short talk, for teams a half-day workshop. Panels and moderating are also available.
Is the keynote available in German or online?
Yes. Every talk can be booked in English or German – on site, online or hybrid, for example for international conferences and distributed teams.
Who in pharma is the keynote for?
For leaders in quality, production, IT, regulatory affairs, medical and compliance – and for boards deciding on AI. In the workshop format your team works on its own use cases.
Does the keynote cover specific products or vendors?
No. The keynote is vendor-neutral and does not assess individual software products. It provides questions you can use to assess any system.
What does a keynote cost?
The fee depends on format, length, location and how much tailoring is needed. You receive an individual proposal. If you have a budget range, feel free to state it in the enquiry form.
How does booking work?
Send the date, location and audience via the form. Sadia De Kiden reviews every enquiry personally. In a 30-minute briefing call you then agree on goals and focus, and you receive the proposal.
More keynotes
Related topics
Contact
Request a date
Share the date, location and audience. You will receive a proposal promptly – or book a 30-minute briefing call right away.