Introduction to Product Development
Online Training Id: PPD-001
Geographical Region: International
Duration: 2 hrs
An overview of the current product and process knowledge required when developing large molecule products.
To Understand the origins of current regulatory requirements and expectations
To gain a top level insight into the application of biopharmaceutics knowledge to product designs
To introduce the concepts of GMP, Quality by Design, and Process Analytical Technologies available to control and manage variability
To gain an overview of the basic stability and impurity data required to support a proposed product shelf life
To understand regulatory requirements for key markets
To understand main reasons why products fail
Who Should Enroll:
Novice pharmaceutical scientists entering the pharmaceutical industry
Experienced pharmaceutical industry switching sectors or roles
CPD Credit hours: 120 mins
Professor Luigi G Martini, BSc (Hons), PhD, FRPharmS, MBA is the UK’s first and only Industrial Pharmacist teaching practitioner as Professor of Pharmaceutical Innovation at King’s College London. He is also co-Director of Rainbow Medical Engineering Ltd, a specialist ultrasonic welding and medical device Fabrication Company. Expert in drug delivery systems, medical device engineering, and personalised medicine; he consults for global companies and regulatory agencies in Europe and the Middle East. He participated in the European Parliament debates and was appointed to the REF2014 sub-panel for Pharmacy, Dentistry, Nursing and Allied Healthcare professionals in 2011.
While at GlaxoSmithKline Pharmaceuticals, he was Senior Director of Pharmaceutical Development for Emerging Markets responsible for developing affordable medicines for the BRIC economies. He developed and commercialised the DiffCORE technology launched in the USA as Lamictal XR, and was instrumental in embedding Quality by Design principles in GSK’s main development and manufacturing sites.
He was a founder of the European Industrial Pharmacy Group and was president of the organization for 10 years. Professor Martini was a Visiting Pharmacy Professor at John Moores University of Liverpool (2006-2011) and designated a Fellow of the Royal Pharmaceutical Society in 2008.
Prof. Luigi Martini
PHARMACEUTICAL INNOVATION, KINGS COLLEGE LONDON