Pharmaceutical Product Development
Package ID: PKG-PPD
Package Geographical Regions: Global
Level : Global
This module is an introduction to International regulatory requirements for Developing , Manufacturing and distributing medicines for Human use and provides a basis for Pharmaceutical Regulatory Affairs knowledge essential for all staff working in Health Care and the Pharmaceutical Industry
On completion of these three courses, the student will have understanding of;
The application of biopharmaceutics knowledge to new product development and design.
The application of genomics data in drug discovery of;
Biomarkers in disease detection; and
Delivery of personalized medicine: targeted therapeutics.
New Drug Development in addressing Antimicrobial Resistance
The concepts of GMP, Quality by Design, and Process Analytical Technologies available to control and manage variability in small and large molecule drugs
An overview of the basic stability and impurity data required to support a proposed product shelf life
Understand the regulatory requirements of these new technologies for key Global markets.
Who Should Enroll:
Staff newly appointed to positions in following positions.
Manufacturing, pharmaceutical manufacturing, engineering, analytical development, packaging development, QC and QA staff.
Clinical trials staff, medical and scientific affairs, medical affairs, and project management.
Pharmaceutical Development & Technology transfer senior managers.
This Package Includes:
Dr Claire Thompson CO-FOUNDER AND DIRECTOR AT NANOSCIENTIUM
Claire is a Co-founder and Director at NanoScientium. Prior to this she was Head of Research and Development with Oxford Pharmascience, an AIM-listed Pharma company identified as one of the "Top 10 Emerging Technology Companies 2012". Oxford Pharmascience develops cutting edge technologies to enable medicines to be safer and easier to take. Prior to this, Claire spent 7½ years in Contract Research Organisations and large Pharma (Pfizer and GSK) developing novel molecules and formulations for therapeutic areas such as asthma, cancer, HIV, insomnia, malaria and pain. She attained increasingly senior roles leading global technical teams across R&D and manufacturing to deliver projects to milestones throughout the development lifecycle.
Claire was appointed Chief Scientist of the Academy of Pharmaceutical Sciences in June 2012 and has been a Board Member of the organisation since 2008. Claire holds a PhD from School of Pharmacy, University of Nottingham, and a BSc in Biochemistry from University of St. Andrews.
Dr Felicity Sartain CO-FOUNDER AND DIRECTOR AT NANOSCIENTIUM
Felicity is a Co-founder and Director at NanoScientium. She is a chemist with 10 years of managerial, commercial and research experience in the life sciences, med tech and clean tech. Felicity was the Programme Director at Bio Nano Consulting, delivering client nanotechnology projects, developing market and business opportunities and securing global contracts. Felicity also led the Healthcare and Life Sciences Theme for the Nanotechnology Knowledge Transfer Network (KTN), supporting the exploitation and commercialisation of micro and nanotechnologies across the UK. Prior to this she worked in research and development at GSK in the Technology Development and at Smart Holograms, a Cambridge University spin-out, which designed and developed novel biosensors, where she was a co-inventor of the original technologies.
Felicity holds an MChem in Chemistry with Life Sciences and Pharmaceuticals from the University of York, and a PhD from the University of Cambridge. Felicity is a Member of and STEMNet Ambassador for the Royal Society of Chemistry and the Nanomedicine Focus Group Leader at the Academy of Pharmaceutical Sciences.
Prof. Luigi Martini PHARMACEUTICAL INNOVATION, KINGS COLLEGE LONDON
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.