What is the Digital CMC CERSI?
The Digital CMC CERSI is a centre of excellence to accelerate the adoption of digital technologies in regulatory processes to ensure faster, more efficient delivery of medicines to patients with reduced environmental impact.
Working collaboratively with a consortium of partners, it will drive the integration of technologies such as AI, machine learning, and hybrid models into regulatory frameworks for Chemistry, Manufacturing, and Control (CMC).
It is one of seven projects funded by Innovate UK, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences and the Medical Research Council (MRC). The Digital CMC CERSI tackles a range of regulatory challenges experienced across the medicines manufacturing industry including:
Many regulatory guidance documents for digital models
Complexity of AI and data-driven predictive systems
Quality, integrity and security of data
Regulatory expertise shortage
Academic, industry and regulatory translation gap
Public perception
This new CERSI represents a new key element of CMAC’s portfolio to drive digital transformation of CMC. The Digital CMC CERSI will accelerate the adoption of digital tools and the benefits they deliver utilising the Pro-innovation Regulation approach outlined by the UK Government and the MHRA.
Aims
Establish an agile, standardised framework
Develop and advocate for a forward-looking agile, standardised regulatory maturity framework to enhance confidence in digital tools.
Drive impact for AI and predictive models
Create an influential CERSI that unlocks the full potential of AI and predictive models in regulatory CMC through exemplar case studies.
Deliver high-impact
training
Create impactful digital CMC training for regulators, industry and academic.
Why digital transformation in regulation matters
Quality by Digital Design (QbDD) is a rapidly emerging systems-level, patient-centric approach to accelerate medicines development and enable regulatory innovation for new medicines approvals. This approach exploits emerging capabilities in industrial digital technologies to achieve robust control strategies assuring product quality and patient safety, whilst reducing development time/costs, improving research and development efficiency, embedding sustainability into new products and processes, and promoting supply chain resilience. Taking a holistic approach considering innovator, manufacturer, regulator and patient will deliver real benefits to the patients, regulators, the planet and society as a whole.
Acceleration
Digital transformation in regulatory practices will help the pharmaceutical industry adapt to the evolving healthcare landscape, ensuring that new medicines are developed, approved, and delivered to patients faster and more efficiently. Medicines development is now often on the critical path of getting new medicines to patients and so new streamlined and agile approaches in development and regulatory processes are required to unlock the potential of digital tools, and AI in particular.
Sustainability
The pharmaceutical sector emits 55% more emissions than the automotive industry, with CMC development producing up to 100kg of waste per kg of product. By integrating digital technologies into regulatory practices, we’ll support the pharmaceutical industry to align with sustainability goals, ensuring that medicines are produced in an environmentally responsible manner.
The impact of digital transformation
Patients
Offers quicker access to better treatments and medicines.
Planet
Reducing waste and creating a sustainable pharma industry.
Economy
Driving growth, and improving global competitiveness.
Events
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