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PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
22 & 23 May 2012
Day 1
Introductions
• The life cycle approach to product development and Quality by Design
• Stability testing in product development
• ICH Q6 – specifications, and how to set them. Role of specifications in
stability testing. Alternative approaches to deriving specifications
Lunch
• ICH Guidance Q1A (R2) – a comprehensive review
• Case study
“Effect of Processing and Formulation Variables on the stability of a salt
of a weakly basic drug candidate (tablet)” – Badawy et al, BMS
• EU GMP guidance on stability testing
DAY 2
• Evaluation of stability data – ICH guidance Q1E. Identifying out of trend
data. Alternative approaches.
• Data interpretation case studies including attendee problems
Lunch
• Bracketing and matrixing designs for stability testing of new drug
substances and products - ISC Q1E
• Photostability testing—Q1B
• Action Planning and Final Q&A
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy
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Organized by:
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Ms Judy Callanan, Event Manager |
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Invited Speakers:
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Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd,
a pharmaceutical consultancy based in Nottingham (UK). Dr Gamlen has over 30 years
experience of tablet development. Awarded a First Class Honours degree in Pharmacy,
specialising in Pharmaceutical Engineering, he studied for a PhD at Nottingham University.
He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and
worked as an outsourcing manager before starting his consultancy business in 2000.
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Deadline for Abstracts:
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Registration:
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REGISTRATION DETAILS
22 & 23 May 2012 - London
2 day course £1180.00 (+ VAT £236.00 if applicable, see VAT NOTES)
2 day course £1062.00 (+ VAT £212.40 if applicable, see VAT NOTES)
if booked and paid eight weeks prior to course commencement
A reduced rate is available if also booking Pharmaceutical Packaging an introductory
course or Introduction to Photostability November 2012 (date to be confirmed)
Discount of 10% applies for booking 8 weeks in advance
Discount of 10% applies for booking more than 1 delegate
Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%
VAT NOTES:
UK: Under UK law all UK-based applications are subject to VAT at the prevailing rate however most UK VAT registered companies/organisations can reclaim this tax.
EU: With effect from 1 January 2011 applications from delegates whose companies are based in EU countries will not be subject to VAT PROVIDED THAT valid VAT ID details are provided at the time of booking, otherwise VAT will be charged.
OTHER: With effect from 1 January 2011 applications from delegates whose companies are based outside of the UK/EU will be outside the scope of VAT, ie no VAT is charged or payable.
Methods of Payment available:
Cheque (Please make payable to PharmaTraining Ltd)
Bank transfer
Credit/Debit Card (Paying by Credit Card please register online)
Registration is available online:
http://www.pharma-training-courses.com/stability-testing-in-pharmaceuticaldevelopment-
and-manufacture_10.htm
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E-mail:
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judy@pharma-training-courses.com
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