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Royal Pharmaceutical Society of Great Britain and JPAG, University of London School of Pharmacy, Brunswick Square, London
13/12/2007
PROGRAMME
10.15 Introduction to symposium : Prof Tony Moffat (Chairman, JPAG)
Session 1 : The extent of the challenge – what the assessors are concerned about
10.20 Malcolm Dash (MHRA,London )
• Impurities control
• Pesticide residues (herbals)
• Residual Proteins (biologicals)
• Extractables and cleaning validation
• Capability and validation of methods
Session 2 What the technology can find – generic approaches and special applications
11.00 Application of Mass Spectrometry techniques for trace analysis
Andrew Ray (AZ, Loughborough)
• MS techniques available for trace analysis
• Different uses of MS in trace analysis
• Quantitation of genotoxic impurities by MS
• The future - analysis without sample pretreatment?
11.35 Analytical strategies for the quantification of trace impurities
Karen Taylor-Worth (Pfizer, Sandwich)
Session 3 When knowing what is there, and how much is there, could be critical!
12.10 Cleaning validation & Specification setting – How clean is clean?
Tim Wood (GSK,Harlow)
12.45 L U N C H
13.40 Case Study on the use of threshold levels for detection of leachables
Arthur J Shaw (Pfizer, US)
• Why the need for leachable thresholds?
• Toxicological justification for Threshold Levels
• Is standardized methodology for leachables determination practicable?
Session 4 Trace Analysis in Practice
14.15 Analysis of Highly Potent Biological molecules - How ‘trace’ is ‘trace’?
Dr Andy Pickett (Ipsen Biopharm, Wrexham)
14.50 Complying with the CHMP Guideline on the Limits of Genotoxic Impurities
Andrew Teasdale (AZ, Loughborough)
15.25 What do the low numbers really mean? Steve Ellison (LGC Ltd,Teddington)
16.00 Chairman’s closure
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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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see website and below
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Deadline for Abstracts:
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-
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Registration:
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REGISTRATION FEES
Registered members of JPAG £ 105
other Members of RSC/RPSGB £105 rate if join JPAG before 6th December, otherwise £ 175
bona fide Retired/Student/Unemployed members of RSC/RPSGB £ 25
Not a member of any of these bodies £ 175
All fees include registration, symposium documentation, morning coffee and lunch
A block booking can be arranged for Students, including documentation but without lunch
PLEASE NOTE that there is NO charge for VAT
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E-mail:
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science@rpsgb.org
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