Innovative Dynamic Medicines Development and Manufacturing Platform
De Montfort University has created a unique Centre for Rapid Medicines Development in a Quality by Design framework on an adaptive Continuous Manufacturing platform. The Centre offers unique, hands-on experience in areas such as formulation, process analytical technologies (PAT) and quality risk management.
Created in collaboration with industry, the workshop content is based on case studies of “real” medicine development and manufacture using configurable technologies with real time in-line process monitoring.
Tutors and advisors from industry
The theory and practical classes are delivered by a world-class team of experts from academia and industry. Our approach is to find agile and efficient ways to supply medicines to clinical trials.
Our tutors:
Walkiria Schlindwein, Associate Director of Pharmaceutics at De Montfort University
Martin Owen, Independent Consultan at Insight by Design and visiting senior lecturer at De Montfort University
Gordon Muirhead, VP at GlaxoSmithKline and visiting professor at De Montfort University
Colm Reddington, Unit Manager (Cardiovascular and Diabetes) at MHRA
Alastair Coupe, Director at Pfizer
Mark Gibson, Independent Consultant (former AstraZeneca) and visiting senior lecturer at De Montfort University
Andreas Berghaus, Director at ColVisTec
Line Lundsberg, Global Technology Partner - GMP and compliance at NNE
The hands-on educational training aims to provide:
- Better process understanding within the Quality by Design framework
- Agile strategies to minimise risks and maximise efficiencies
- Real examples of in-line product quality monitoring (PAT) and process performance
- Regulatory considerations within product development and manufacture
Who should attend?
The hands-on workshops are designed for employees, specialists and managers (biologists, chemists, process and chemical engineers, pharmacists, physicists, materials scientists) who are involved in medicines development and manufacture.
Bespoke training options
One day: Introduction taster day. This course is targeted to professionals that have limited experience on how to integrate quality by design methodology in continuous manufacture of medicines. It is focused on practical activities to demonstrate how quality by design can be applied in continuous tablet manufacture.
Two and a half days: This option provides a deeper understanding of product design and manufacture including quality target product profile, risk assessment, design of experiments and continuous manufacture of “real” medicines. Putting theory into practice!
Four days: In addition to what is covered in two and a half days, this option expands into physical characterisation of tablets, analysis (modelling) of the impact of potential critical material attributes and process parameters on critical quality attributes of the tablets produced using configurable extrusion platforms. Real examples of inline process monitoring (PAT) and regulatory considerations are included.
Delegates from GlaxoSmithKline are saying...
“Excellent course - great to have theory AND practice at the same time”
“Great chance to get hands-on to actually develop and make a tablet!”
“DMU staff were great, very knowledgeable. There's a lot crammed into four days, but the event was really well structured and supported by DMU staff"
Contact us
To receive more information please contact us at wss@dmu.ac.uk or qbd@dmu.ac.uk