| |
|
|
|
PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
21 & 22 November 2012
Day 1
The course will commence at 8.30 with registration and coffee, course proper will commence at 9.00 and finish at 5.00pm each day
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
|
|
|
|
|
|
|
|
Organized by:
|
|
PharmaTraining Ltd |
|
|
Invited Speakers:
|
|
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.
Dr Gamlen specialises in managing product development, formulation, tablet and process
development studies. He has been teaching professional tabletting courses for many years and
his courses are highly rated, exceeding the expectation of the participants in many cases.
Michael continually updates the content of his courses with the latest guidance and
extracts of up-to-the minute scientific papers.
He provides a substantial body of relevant literature to all course participants
as well as copies of all notes and guidance used and a workbook. He is a
popular and highly respected presenter.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
.
|
|
|
|
|
|
|
|
Registration:
|
|
Early-bird Fee: 2 day course £1062.00 (+ VAT £212.40 if applicable, see VAT NOTES) if booked and paid eight weeks prior to course commencement
Full Fee: 2 day course £1180.00 (+ VAT £236.00 if applicable, see VAT NOTES)
A reduced rate is available if also booking “Pharmaceutical Packaging - an introductory course” or “Introduction to Photostability” 23 November 2012
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%
|
|
|
E-mail:
|
|
judy@pharma-training-courses.com
|
|
|
|
|
|
|
|
|