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Royal Pharmaceutical Society of Great Britain and APS, Moller Centre, Cambridge, UK
18/02/2008 - 20/02/2008
OUTLINE PROGRAMME • Setting the stability scene • Overview of stability testing • Chemical and physical aspects of drug substance and drug product stability • Development pharmaceutics and stability testing • Rational design of stability testing methods • Selection and validation of stability-indicating analytical methods • Stability testing of biotechnology products • Stability assessment of complex formulations and devices • Product packaging and stability testing • Application of statistical tools for the assessment and interpretation of stability data • UK and European regulatory perspectives on stability testing • International aspects of stability testing for product registration • Characterising materials with respect to physical stability • New approaches to stability testing such as isolinear methods and PAT. • Quality by design, Right fi rst time and Bio-investment paradigm philosophies • Practical aspects of fi nished product testing
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Organized by:
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Royal Pharmaceutical Society of Great Britain |
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Invited Speakers:
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LEARN FROM A TEAM OF EXPERTS Course Director Kevin Ryan, Pfi zer Global Research and Development Kevin Ryan is an Associate Director, Analytical R&D, Worldwide Pharmaceutical Sciences (WWPS), and is based in Sandwich, Kent. He currently runs a clinical stability team and dissolution development team. He has 19 years experience in several analytical roles including support for a wide variety of Human and veterinary APIs and drug products at all stages of development from discovery through to registration, and has led a team delivering global method validation guidance to WWPS. Kevin joined Pfi zer in 1987 after successful completion of studies at the University of Strathclyde in Forensic science and Irish technical colleges in applied toxicology and biology. Dr Andy Rignall, AstraZeneca R&D Dr Rignall is an Associate Director at AstraZeneca Charnwood and has worked as an Analytical Chemist in the Pharmaceutical Industry since 1987, after leaving the University of Bradford with a PhD (a study of the adsorption of organophosphorous compounds onto clays). Stability testing has formed a signifi cant part of his career to date and he has been involved with projects at all stages of development from preclinical to registration. More recently, Andy has become involved with packaging and device development and is gaining a better understanding on how and where these aspects fi t into the stability puzzle. Dr Graham Leonard, GlaxoSmithKline Dr Leonard is Director of Pharmaceutical Development, New Chemical Entities, Harlow. He graduated in 1967 from The School of Pharmacy, University of London and followed this with a PhD, working on research into properties of compressed tablets. He has worked in the Pharmaceutical industry for more than thirty years in the fi eld of pharmaceutical development, with his fi rst appointment being with Eli Lilly at the Lilly Research Centre Ltd., before joining Smith Kline & French Laboratories Limited in 1973. His career developed here through a series of posts (and company transformations) with increasing seniority, culminating in his present position at GlaxoSmithKline. He has experience of a wide range of dosage forms and lists Tagamet®, Seroxat®, Ridaura® and Avandia® amongst the successful products he has developed. In his current role he has prime responsibility for all pharmaceutical aspects in the selection of NCE development candidates in the areas of Neurology and GI and their subsequent development through clinical trials and registration to commercial production. Dr Andrew Lipczynski, Pfi zer Global R&D Until recently, Dr Lipczynski was a Senior Director in Analytical R&D, Worldwide Pharmaceutical Sciences, Sandwich Laboratories, Pfi zer Global R&D, responsible for providing all analytical support and stability studies for the development of human and veterinary medicinal projects, from late Discovery through Phase III studies to technology/knowledge transfer to manufacturing and to global registration and postapproval activities. His current role is Research Fellow, responsible for Intellectual Property Management and CMC review of Licensing & Development opportunities. He has experience in the pharmaceutical development of both conventional NCEs and biologic NMEs, a diverse variety of dosage formulations and associated specialised drug delivery technologies such as inhaled and oral modifi ed release drug products. Andrew joined Pfi zer in 1987 after PhD studies at the University of Bath researching the degradation and analysis of beta-lactam antibiotics. Dr Paul Royall, King’s College London Dr Royall lectures in pharmaceutics at King’s College London. Paul Royall has many years of experience in applying thermal analysis and calorimetry to the characterisation of pharmaceutical materials. He has been on the committee of Thermal Analysis group of the Royal Society of Chemistry and is on the Editorial Board of Thermochimica Acta. Paul’s fi rst degree was Chemistry and his Ph.D. supervised by Prof A.E. Beezer was an investigation of the thermodynamics and kinetics of transfer across model biophases in particular DPPC SUV liposomes. Both of these degrees were awarded by the University of Kent at Canterbury. Since then Paul’s area of research has progressed towards solid state issues, namely processed induced disorder, amorphous formulation and polymorph stability. These research themes were developed during his post-doctoral positions at the School of Pharmacy University of London and The Queen’s University of Belfast. Ms Sue Harris, Medicines and Healthcare products Regulatory Agency Ms Harris graduated from the School of Pharmacy University of London in 1975. After completing her pre-registration year, she worked as a community pharmacist until 1986 when she changed direction completely and joined Licensing Division of the Department of Health as a Pharmaceutical Offi cer, assessing applications for parallel imports. Ms Harris obtained an MSc in biopharmacy from Chelsea College (now part of Kings College) in 1990 and on creation of the Medicines Control Agency (now the MHRA) moved across to assessing the chemistry and pharmacy dossiers for abridged applications. Since then she has been responsible for assessing new drug applications as well as abridged applications both nationally and through the mutual recognition and centralised procedures and is currently Unit Manager of the anti-infectives, genito-urinery and obstetrics and gynaecology product lifecycle assessment team. Dr Jon Beaman, Pfi zer Dr Beaman is a Senior Director, Analytical R&D, Worldwide Pharmaceutical Sciences, and is based in Sandwich, Kent. He runs the Pfi zer Global Stability Group, with teams based in both the UK and the US, responsible for designing and running all stability studies for Pfi zer small molecule new chemical entities. He has 14 years experience in a variety of analytical roles including support for a wide variety of APIs and drug products at all stages of development, setting up and running a pilot plant analytical support unit, running a separation sciences group and being responsible for an analytical group supporting all aspects of the veterinary medicine portfolio covering a large number of products and dosage form types. Dr Beaman studied for his PhD in chromatography/mass spectrometry with Professor Dai Games at Swansea. Mr Gerry Maxwell, NDA Analytics Mr Maxwell graduated in Biochemistry from Queens University Belfast in 1982 and obtained his Masters degree in Analytical Chemistry from the same university in 1983. He has worked in pharmaceutical analysis for 20 years and is currently Head of Pharmaceutical Analysis & Quality Control at the contract laboratory, NDA Analytics. He is responsible for methods development and validation, compound and product characterisation, stability testing and QC release testing (both for marketed products and Investigational Medicinal Products, IMPs), undertaken on behalf of pharmaceutical and biopharmaceutical companies. He is a Qualifi ed Person for release of IMPs in the EU. In his role, he has been the lead respondent during several MHRA and FDA PAI GMP inspections of his facility.
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Deadline for Abstracts:
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ASAP
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Registration:
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DELEGATE FEES FIXED AT 2007 RATES – Delegate fees for the 2008 course will remain at the 2007 rate of £1,760 or £1,690 for members of the Royal Pharmaceutical Society or the Academy of Pharmaceutical Sciences. The fees are inclusive of 2 nights’ accommodation, meals and refreshments, a welcome reception and a resource pack with full course documentation and CD-ROM. REGISTER BY 30 NOVEMBER 2007 FOR THE EARLY BIRD FEE OF £1,640
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E-mail:
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science@rpsgb.org
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