Credibility Assessment of Digital Predictive Tools in CMC

Credibility Assessment of Digital Predictive Tools in CMC
AI  and digital predictive tools are rapidly transforming pharmaceutical development, but success depends on using them in ways that are scientifically robust, explainable, and regulator-ready. This webinar will help you move beyond awareness to practical application, showing how AI and predictive digital tools can be developed, governed, and justified within regulated environments. Through real-world examples from pharmaceutical manufacturing, you’ll gain clarity on what good practice looks like and how to align innovation with regulatory expectations. Bought to you by the Chemical Manufacturing and Controls SPIN




Date: Tuesday 31 March 2026
Time: 11:00 - 12:00  GMT




What you'll learn


By attending, you'll gain:

  • A clear understanding of the AI and digital predictive tool landscape in CMC
  • Practical insight into scientific and regulatory best practices, including data management and model development 
  • Guidance on applying the MHRA’s Five Principles of AI in real-world settings
  • Awareness of collaborative research and pre-competitive initiatives shaping digital CMC adoption, including work from the Digital CMC Centre of Excellence in Regulatory Science and Innovation (CERSI)

Who should attend

This webinar is ideal for Industry R&D and manufacturing professionals, regulatory affairs specialists, regulators, industry leaders, and academia.


Webinar host & presenters


Host: Francisco Simões Baptista
 

Francisco is the current Chair of TOPRA’s CMC SPIN and works as a Senior Regulatory Affairs Manager – Team Lead at Arriello. He holds a Master’s degree in Pharmaceutical Sciences from the University of Coimbra, Portugal, and is a certified RSCi Scientist by the Science Council. With over nine years of experience in pharmaceutical regulatory affairs and consulting, he has extensive expertise in managing the entire regulatory process—from early development and strategic planning to marketing authorisation and lifecycle activities.

Francisco has led a broad range of regulatory activities, including Early Development activities (such as Scientific Advice, PIP, ODD, PRIME), Marketing Authorisation Applications (MAAs), variations, renewals, and lifecycle management across more than 30 markets worldwide (EU, South America, Africa, Asia, and Oceania).

From the beginning of his career, he has been deeply involved in CMC writing, from pharmaceutical development and initial dossier preparation to managing variation submissions, fostering his passion for dossier quality. His expertise extends to the coordination and strategic management of technology transfers, where he played a key role in ensuring quality compliance and regulatory alignment for a wide range of products and pharmaceutical forms.

 
 

Presenter: Ian Houson
Programme Manager, Digital CMC CERSI

Ian is Programme Manager for the Digital CMC Centre of Excellence in Regulatory Science and Innovation (CERSI) at CMAC, University of Strathclyde. He leads initiatives to accelerate the adoption of digital tools in regulatory submissions and inspections, pioneering the use of Quality by Digital Design (QbDD) through physics-based and AI-driven modelling.

Ian previously held technical, managerial, and consultancy roles in agrochemicals and pharmaceuticals, spanning SMEs, CDMOs, and large pharma. He is editor of Process Understanding for Scale-up and Manufacture, with numerous patents and publications, and holds a DPhil in Organic Chemistry from the University of Oxford.

  Presenter: Dr Chantal Mustoe
Digital CMC CERSI Research Fellow and Training Developer

Chantal is Research Fellow and Training Developer for the Digital CMC CERSI at CMAC, University of Strathclyde, supporting the integration of digital tools in regulatory contexts. With over a decade of research experience spanning chemistry, machine learning, and automation, she has worked across academia, industry, and government.

Chantal designs and delivers training for regulators, industry, and developers on credibility assessment of digital predictive models. Her work has been recognised with multiple awards for innovative teaching and knowledge exchange in complex interdisciplinary environments.

Pricing

 Standard webinar registration fees
 Webinar Registration Type Price (GBP)
 Standard Price 
 TOPRA Member
FREE
 Standard Price
 Non-member
£60.00






 

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When
31/03/2026 15:00 - 16:00
Where
ONLINE
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