This presentation will look at where advancements are being made in the use of AI and digitization in Pharmaceutical Manufacturing and Quality. Exploring what hurdles this may present with regulators and also what challenges Regulators are having themselves in being able to regulate and inspect in this space
Over 30 years’ experience of influencing within the pharmaceutical, biotech, medical device and life sciences sector, with a proven track record of challenging norms, developing innovative solutions to issues, and enhancing regulatory compliance.
A passion for delivering regulation in a risk proportionate way and establishing pragmatic, forward thinking, approaches to regulatory oversight; specifically, development of interventional educational approaches to enhance compliance.
Demonstrated success in building and leading high performing teams responsible for multi-million pound income.
Former Head of the MHRA Inspectorate with recognised national with international influence through being a member of the PIC/S Executive Bureau, extensive key note speaking engagements at influential conferences and seminars, and at MHRA having wide-ranging inter agency meetings, including US FDA, cross EU, ANVISA, TGA, SID&GP, Health Canada, PDMA and Medsafe. Eligible to be named as a Qualified Person and has an MBA from Warwick Business School.
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