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PASG - Spring Meeting, Scarman House, Warwick 16-17th April 2007
    
Quality is a fundamental building block of Pharmaceutical Analysis and
current focus on Quality by Design highlights the importance of building
quality into all aspects of the development and commercialisation process.
The scientific programme of the PASG "Pharmaceutical Analysis Designed for
Quality" meeting will cover diverse aspects of quality within
Pharmaceutical Analysis and include presentations on dissolution, forced
degradation studies, raman optical activity, the role of the USP, solid
state NMR and the ICH guidance documents Q8, Q9 and Q10, as well as
workshops and open discussion.
Date: |
16-17th April 2007 |
Location: |
Scarman House, Warwick
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Application and Fees: |
On Monday or Tuesday without accommodation at £ 125 per person
On Monday and Tuesday without accommodation at £ 250 per person
With accommodation (Mon) at £ 375 per person
Limited accommodation is available on Sunday night at £75 (B&B). Please book directly with Scarman House.
Note: Dinner is included with accommodation on Monday
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For Further Information: |
Please contact Michele Sahrle. |
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Monday, 16th April 2007 |
(All Lectures will be held in Lecture Theatre 9 unless otherwise indicated) |
Pharmaceutical Analysis Designed for Quality Agenda |
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10:15 |
Registration and Coffee |
10:30 |
Welcome by PASG Chairman Gareth Pearce, MSD |
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Session 1: Quality by Design, (Chaired by Adrian Parkinson, 3M) |
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10:35 |
Overview of ICH Q8 and Q9 Andy Townsend, AstraZeneca |
11:35 |
"Application of the Principles of Quality by Design to Analytical Methods" Phil Borman & Marion Chatfield, GSK |
12:30 |
LUNCH |
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Session 2: Quality by Design, (Chaired by Phil Jupp, Wyeth) |
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Workshops to follow on from morning presentations |
13:45 |
Parallel Workshop on Q8/Q9 Andy Townsend, AstraZeneca & Phil Jupp, Wyeth |
13:45 |
Parallel Workshop on Q8/Q9 (Lecture Theatre 5) Phil Borman, GSK & Jayne James, Sanofi-Aventis |
15:15 |
TEA |
15:30 |
Feedback from workshops & discussion |
16:15 |
ICH Q10 - Pharmaceutical Quality System Neil Wilkinson, AstraZeneca |
17:00 |
PASG Committee Meeting |
19:30 |
DINNER |
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Monday, 16th April 2007 |
(All Lectures will be held in Lecture Theatre 6) |
Biopharm Agenda |
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10:15 |
Registration and Coffee |
10:30 |
Welcome to Biopharma meeting Carl Jone, Merck Serono |
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Session 1: Rapid Analytical Methods, (Chaired by Mike Davies, Lonza) |
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10:35 |
Lab-on-a-chip for pI measurements Arthur Watson, Convergent |
11:35 |
Rapid Identification and quantification of post translational modifications by UPLC Anna Izzo, Merck Serono |
12:30 |
LUNCH |
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Session 2: Rapid Glycoform Analysis, (Chaired by Peter Whyment, Lilly) |
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13:45 |
Rapid HPLC methods Mike Davies, Lonza |
14:30 |
HPLC on-line measurements to control product quality Lance Smallshaw, Lilly
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15:15 |
TEA |
15:30 |
Progress in measuring O-glycosylation in biopharmaceuticals Daryl Fernandes, Ludger |
16:15 |
Rapid N-glycosylation measurements To be confirmed, M-Scan |
17:00 |
PASG Committee Meeting |
19:30 |
DINNER |
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Tuesday, 17th April 2007 |
(All Lectures will be held in Lecture Theatre 9) |
Session 3: Pharmaceutical Analysis in QbD, (Chaired by Graham Clarke, BMS) |
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09:00 |
Perspectives on Forced Degradation Studies: |
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BMS perspective on Drug Product Forced Degradation Studies Adele Patterson, BMS |
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Forced Degradation Studies: A Perspective on Inhalation Products Nicola Gillott, 3M |
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Practical Approaches to conducting forced degradation studies Keith Parker, AstraZeneca |
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Open Discussion |
10:30 |
COFFEE |
10:45 |
The role of Dissolution in Quality by Design Dónal Murphy, AstraZeneca |
11:15 |
Designing a Quality Dissolution Method Terry Way, USP |
11:45 |
Solid State NMR in Pharmaceutical Development Les Hughes, AstraZeneca |
12:15 |
LUNCH |
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Session 4: Quality, A Broader Perspective, (Chaired by Gareth Pearce, MSD) |
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13:15 |
Public Standards for Pharmaceutical Analysis: A USP Perspective Shawn Dressman, USP |
14:00 |
Raman Optical Activity and its uses in the Pharmaceutical Industry Prof George Tranter, Chiral Labs |
14:30 |
PASG Future Objectives Gareth Pearce,MSD |
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Autumn 2007 meeting overview |
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Chairman's closing remarks |
15:00 |
End of meeting |
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Tuesday, 17th April 2007 |
(All Lectures will be held in Lecture Theatre 6 unless otherwise indicated) |
08:55 |
Session 3: Progress in Spectroscopic measurements, (Chaired by Lance Smallshaw, Lilly) |
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09:00 |
Monitoring changes in carbohydrate quality following process changes Keith Wilson, GSK |
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09:45 |
Monitoring Post Translational Modifications by CD, and IR Marco Barba, University of Roma III, Italy |
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10:30 |
COFFEE |
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10:45 |
Results from HCP/HCD detection programme(PASG / DTI sponsored MfB PC1 project) Anna Hills, National Physical Laboratory Monitoring Post |
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11:15 |
Workshop: Future meetings |
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12:15 |
LUNCH |
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Session 4: Quality, A Broader Perspective (Chaired by Gareth Pearce, MSD) (Lecture Theatre 9) |
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13:15 |
Public Standards for Pharmaceutical Analysis: A USP Perspective Shawn Dressman, USP |
14:00 |
Raman Optical Activity and its uses in the Pharmaceutical Industry Prof George Tranter, Chiral Labs |
14:30 |
PASG Future Objectives Gareth Pearce, MSD |
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Autumn 2007 meeting overview |
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Chairman's closing remarks |
15:00 |
End of meeting |
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