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Workshop overview

Discover how AI and digital transformation are revolutionizing pharmaceutical manufacturing while meeting evolving regulatory requirements. This practical workshop explores high-impact AI applications, regulatory compliance, cybersecurity considerations, and proven strategies for implementing digital solutions with confidence. Join industry experts to gain actionable insights and a clear roadmap for driving innovation in a regulated environment.

Workshop Agenda

1st of September 

ACT 1-The Mandate: What the Regulator Now Requires

  • 11:20 – 11:32: The Global direction of travel
  • 11:32 – 11:44: The frameworks you will be held to
  • 11:44 – 11:52: The hard part: validating AI 
  • 11:52 – 12:00: Table-talk + poll #2 
  • 12:00 – 12:15: Break

1st of September 

ACT 2 — The Reward: Where AI Actually Pays Back

  • 12:15 – 12:25: The value framework
  • 12:25 - 12:45: High-ROI use cases (the core)
  • 12:45 - 12:55: Case study: a real before/after
  • 12:55 - 13:05: Poll #3 + table-talk

1st of September

ACT 3 — The Risk: How These Systems Fail 

  • 13:05 - 13:18: Risk class 1: the data & the model
  • 13:18 - 13:38: Risk class 2: cybersecurity
  • 13:38 - 13:48: Defending: practical controls
  • 13:48 - 13:55: Poll #4
  • 13:55 - 14:05: Break


1st of September

ACT 4 — The Roadmap: Starting Without Betting the Plant

  • 14:05 - 14:15: Assess before you buy
  • 14:15 - 14:28: Pilot, gate, scale
  • 14:28 - 14:40: he vendor & buildvs-buy questions
  • 14:40 - 15:00: Consolidated Q&A

Our Instructor

Eng. Yara Al Mouti
CEO and Projects Director at Agon Pharmaceutical Consulting

Yara is a passionate and enthusiastic consultant with more than 19 years of experience. She has an extensive background in topics related to cGMP, GSDP and Quality Management systems. She has analytical and conceptual thinking skills which enable her to effectively partner with senior managers to assess companies’ current statuses, facilitate brainstorming for strategic decisions, and drive successful implementations.

Yara’s ability to assess complex situations and identify appropriate and innovative solutions underscores her ability to gain meaningful insight and follow up with thorough analysis. She is particularly skilled at performing mock audits, gap analysis, due diligences and group facilitation.

Workshop Partner