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

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

For Further Information: Please contact Michele Sahrle.

Monday, 16th April 2007
(All Lectures will be held in Lecture Theatre 9 unless otherwise indicated)
Pharmaceutical Analysis Designed for Quality Agenda
10:15 Registration and Coffee
10:30 Welcome by PASG Chairman
Gareth Pearce, MSD
Session 1: Quality by Design, (Chaired by Adrian Parkinson, 3M)
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
Session 2: Quality by Design, (Chaired by Phil Jupp, Wyeth)
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
 
Monday, 16th April 2007
(All Lectures will be held in Lecture Theatre 6)
Biopharm Agenda
10:15 Registration and Coffee
10:30 Welcome to Biopharma meeting
Carl Jone, Merck Serono
Session 1: Rapid Analytical Methods, (Chaired by Mike Davies, Lonza)
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
Session 2: Rapid Glycoform Analysis, (Chaired by Peter Whyment, Lilly)
13:45 Rapid HPLC methods
Mike Davies, Lonza
14:30 HPLC on-line measurements to control product quality
Lance Smallshaw, Lilly
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
Tuesday, 17th April 2007
(All Lectures will be held in Lecture Theatre 9)
Session 3: Pharmaceutical Analysis in QbD, (Chaired by Graham Clarke, BMS)
09:00 Perspectives on Forced Degradation Studies:
BMS perspective on Drug Product Forced Degradation Studies
Adele Patterson, BMS
Forced Degradation Studies: A Perspective on Inhalation Products
Nicola Gillott, 3M
Practical Approaches to conducting forced degradation studies
Keith Parker, AstraZeneca
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
Session 4: Quality, A Broader Perspective, (Chaired by Gareth Pearce, MSD)
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
Autumn 2007 meeting overview
Chairman's closing remarks
15:00 End of meeting
 
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)
09:00 Monitoring changes in carbohydrate quality following process changes
Keith Wilson, GSK
09:45 Monitoring Post Translational Modifications by CD, and IR
Marco Barba, University of Roma III, Italy
10:30 COFFEE
10:45 Results from HCP/HCD detection programme(PASG / DTI sponsored MfB PC1 project)
Anna Hills, National Physical Laboratory Monitoring Post
11:15 Workshop: Future meetings
12:15 LUNCH
Session 4: Quality, A Broader Perspective (Chaired by Gareth Pearce, MSD) (Lecture Theatre 9)
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
Autumn 2007 meeting overview
Chairman's closing remarks
15:00 End of meeting