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The GxP Quality x AI Innovation Summit

  • 9 - 10 March 2027
  • Amsterdam, The Netherlands
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The GxP Quality x AI Innovation Summit

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Turn AI Risk Into Regulatory Readiness

Pharma quality teams are already facing regulatory warning letters citing AI overreliance, inspection findings built on fabricated AI-generated content, and shadow AI use spreading through GxP-adjacent work with 77% of staff turning to ungoverned tools — all while EU GMP Annex 22 and the EU AI Act’s high-risk provisions close in fast.

The GxP Quality x AI Innovation Summit brings together senior QA, regulatory, and compliance leaders across GCP, GMP, and GDP to convert AI ambition into validated, inspection-ready practice — grounded in real enforcement cases, not hype.

Event speakers

Nuno Valério | Speaker | Fleming
Linkedin
Nuno Valério
Head of Innovation, R&D Quality
Merck, Germany
Kristoffer Lindner | Speaker | Fleming
Linkedin
Kristoffer Lindner
VP Quality for Operations
dsm-firmenich, Netherlands
Marta Rodriguez Velez | Speaker | Fleming
Linkedin
Marta Rodriguez Velez
Head of Corporate Quality
LETI Pharma, Spain
Ewa Rybak | Speaker | Fleming
Linkedin
Ewa Rybak
Head of Quality Compliance and Quality Systems/Qualified Person
JJP Biologics, Poland
Maxim Bunimovich | Speaker | Fleming
Linkedin
Maxim Bunimovich
CEO & Co-Founder
The QARP, Spain
Natalia Vtyurina | Speaker | Fleming
Linkedin
Natalia Vtyurina, PhD
Chair of ISPE NL Quality CoP
ISPE, Netherlands
Martin Heitmann | Speaker | Fleming
Linkedin
Martin Heitmann
Secretary of the GAMP Global Special Interest Group Software Automation & Artificial Intelligence
ISPE, Germany
Pourya Vali | Speaker | Fleming
Linkedin
Pourya Vali
Founder
Nordic GxP Compliance, Denmark
Georgi Gerov | Speaker | Fleming
Linkedin
Georgi Gerov, MD
Founder & Enterprise Quality Consultant
Q CONS Consulting, Switzerland
Barbara Glantschnig | Speaker | Fleming
Linkedin
Barbara Glantschnig
SVP Global Quality, Plasma Derived Therapies
Takeda, Austria
Milind Nadgouda | Speaker | Fleming
Linkedin
Milind Nadgouda
Co-founder and Director of Operations
RiverArk, United Kingdom
CONFERENCE

Highlights

  • 20+ Senior Thought Leaders
  • 15+ Hands-on Presentations and Case Studies
  • 120+ Senior Expert Attendees
  • 6+ hours of Networking and Collaboration
Conference

Brochure

Get the complete program line-up, speaker details and more.
download brochure
The GxP Quality AI Innovation Summit organized by Fleming_Agenda Cover

WHY ATTEND THE GXP QUALITY X AI INNOVATION SUMMIT?

  • Get ahead of the rules that are about to bind you:
    Understand what EU GMP Annex 22, ICH E6(R3), and the EU AI Act's 2027 high-risk provisions actually require — and where the current guidance stops short, leaving you to decide how much risk is acceptable.

  • Close the gap between shadow use and sanctioned AI:
    Build a practical inventory and risk register for the AI already running inside your quality system, and take home a governance model that covers vendor- embedded AI, not just the tools you built yourself.

  • Turn compliance into operating advantage:
    See documented results — faster deviation closure, reduced audit-prep time, earlier CAPA detection — from organizations that treated AI governance as a capability to build, not just a box to check.

What Previous Attendees Say

It was a pleasure to participate in the Pharma and Biotech Quality Summit and to contribute as a speaker. I truly appreciated the opportunity to share experiences and exchange perspectives with other professionals from the industry.
Ewa RybakJJP Biologics
The conference was massively interesting for me to meet QA professionals, to have an opportunity to discuss all the challenges in the field and to understand that we're all suddenly got the same topics with the same challenges.
Aleksandra WojtowMedPharm
My expectation was quite high, and so far, these 2 days have been highly rewarding with colleagues presenting not only um, their perspectives, but also real cases where we can learn from each other experience.
Sandra Lopes GuerreiroESTEVE
Everything was great, really, great organization and very good networking and topics.
Fabio GeremiaQualified Person
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Contact us

Natalie Pearson | Marketing Manager | Fleming
Linkedin
Natalie Pearson
Marketing Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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