Regulatory implications and practical application in the pharmaceutical industry
Artificial Intelligence is beginning to be incorporated into different processes within the pharmaceutical industry, but its use in GMP environments raises new questions related to regulation, validation, data integrity and governance.
This training will provide a practical perspective on how to approach the implementation of AI in regulated environments, combining the regulatory perspective with real-world experiences of AI implementation in the pharmaceutical industry.
The session will cover the main implications of the new AI regulatory framework, the specific aspects that need to be considered in GMP environments, and the challenges that arise during implementation.
Miguel Ángel Campanero
CEO of A3Z Advanced
PhD in Pharmacy and specialist in Industrial and Galenic Pharmacy and in Drug Analysis and Quality Control. He has extensive experience in regulatory affairs, the development and validation of analytical methodologies, and GxP environments.
During the training, he will analyse the implications of the new Artificial Intelligence regulatory framework, as well as the key aspects to consider when applying and governing AI in GMP environments. He will also address the future Annex 22 of the EU GMP Guidelines, focused on the use of Artificial Intelligence.
Jesús López Lobo
FAES
He will share real-world experiences of Artificial Intelligence implementation in the pharmaceutical environment, addressing some of the challenges encountered during implementation and the key lessons learned.
His contribution will provide a practical perspective on how AI is being incorporated into pharmaceutical industry processes and the aspects that need to be considered when applying it in regulated environments.
Round table
The session will conclude with a round table on the challenges and opportunities arising from the adoption of AI in the pharmaceutical industry, providing an opportunity to share experiences and ask questions.
📅 15 October 2026
🕤 9:30 AM – 12:30 PM
📍 BIC Bizkaia
A training session for professionals interested in understanding how to approach the implementation of AI in regulated environments, combining both regulatory and practical perspectives.
