Your course checklist:

✓ In-depth guidance into the key stages of pharma-ceutical analysis

✓ Interactive breakout sessions to enable you to workthrough examples

✓ Unique access to pharmaceutical experts to answeryour questions

✓ Fully residential - 3 nights accommodation andmeals included

✓ Full course notes given

✓ Certificate of attendance & 16 hours of professionaldevelopment

Your expert faculty includes:John Nightingale, PrincipalAnalytical Chemist, Process R&D,AstraZeneca

Geoff Carr, Director AnalyticalDevelopment, Patheon Inc

Michael Ulmschneider,Pharmaceutical Quality Control, F. Hoffmann La Roche

Mark Benger, Senior Scientist, Aptuit

Howard Hill, Group Director, NDAAnalytics

Donald Daley, Director Analytics, ITand Early ADME, Argenta

Lesley Bugg, Team Manager,Pharmaceutical, Analytical R&D,AstraZeneca

Stephen Robinson, Senior Director,Pharmaceutical Sciences, Pfizer

Gerry Maxwell, Head ofPharmaceutical Analysis, NDAAnalytics

Esmaeil Ektefaie, TechnicalSupervisor, QA, Baxter, Austria

www.ibc-lifesci.com/pharmanalysis

£300 discount

for new EU

mem

ber

states and EU accession

countries

(see back page for details)

Supported by:

3-DAY RESIDENTIAL COURSE: FROM DISCOVERY TO PRODUCTION

“A great overview about analytical aspects in every stage of

development of a compound, I enjoyed it” Roche Diagnostics

The leading provider of scientific, technological and business information

PHARMACEUTICALANALYSISCOURSE

IBC’s 4th Successful Annual

24 – 26 April 2006 | Thistle Hotel, Brighton, UK

Get to grips with technical jargon andunderstand the challenges of:• HPLC methods

• Preclinical formulation analysis

• Validation of analytical methods

• Stability indicating methods and protocols

• Managing impurities and degradation products

• Process Analytical Technologies....and much more!

Register online at www.ibc-lifesci.com/pharmanalysis

24 - 26 April 2006 PHARMACEUTICAL AN

DAY ONE: 24 APRIL 2006 | DRUG DISCOVERY

08.30 Registration & coffee

09.00 Welcome from your course leader and anintroduction to the role of pharmaceuticalanalysis within the drug development processHoward Hill, Group Director, NDA Analytics, UK

09.30 High throughout Vs high content analytics indrug discoveryVisit www.ibc-lifesci.com/pharmanalysis for more detailsDonald Daley, Director Analytics, IT and Early ADME,Argenta, UK

10.00 Structural eludication and characterisation –Analytical tools Visit www.ibc-lifesci.com/pharmanalysis for more detailsInvited: Adrian Davis, Associate Research Fellow, AnalyticalR&D, Pfizer, UK

10.30 Coffee and morning refreshments

11.00 Developing HPLC methods for related substancesThis presentation will cover the development of HPLCmethods for the characterisation and control of drugsubstances and related intermediates. Examples anddiscussion will include the following topics:

Control and tracking of organic impurities throughout thesynthetic routeUse of generic HPLC methods and method screening tosupport early drug developmentDevelopment and optimisation of HPLC methods forregulatory drug development

John Nightingale, Principal Analytical Chemist, Process R&D,AstraZeneca, UK

11.30 Worked example: HPLC method screening anddrylab optimisationThe delegates will be divided into a number of groups andwill be asked to improve an existing separation which hassome co-eluting impurity peaks. They will discuss variousstrategies to resolve all peaks and can then requestchromatograms that have been previously obtained usingdifferent columns, modifiers and additives during methodscreening. The objective of the task is to select a suitableseparation for final optimisation of a robust long termmethod, using the least amount of effort.John Nightingale, Principal Analytical Chemist, Process R&D,AstraZeneca, UK

12.30 Lunch

13.30 Preclinical formulation analysisHow much assay validation is appropriate? What are thesample acceptance criteria and are ICH guidelines and/orvariations appropriate?

Implication of different formulations and dosage route e.g.i.v., oral, sc and inhalation on the validation andimplementation of analytical methods

Impact of differences in test article e.g. small molecules,peptides and macromolecules on assay development andvalidation requirements

Dosage content, formulation uniformity and stabilityissues, what is fit for purpose?

Impact of preclinical study design on assay developmentand sample

Howard Hill, Group Director, NDA Analytics, UK

14.15 What is required for validation of methods fordrug substances?Invited: Dave Malpas, Validation Manager, Quality Assurance,sanofiaventis, UK

15.00 Worked example: Dealing with a problem inmethod validationInvited: Dave Malpas, Validation Manager, Quality Assurance,sanofiaventis, UK

16.00 Regulatory guidance on reference standardsJohn Miller, Head of Division 3 Laboratory, EuropeanDirectorate for the Quality of Medicines (EDQM, part ofthe Council of Europe), France

16.45 End of day one and coffee

19.30 Course dinner at the hotel

DAY TWO: 25 APRIL 2006 | DRUG DEVELOPMENT

08.00 Breakfast

08.45 Welcome to day two from your course leaderGeoff Carr, Director Analytical Development, Patheon Inc,Canada

09.00 Cleaning ValidationDevelopment of cleaning methodsCleaning validation including acceptance criteria, samplingmethodsMonitoring (verification of cleaning procedure uponvalidation) for pharmaceutical equipments/units

Esmaeil Ektefaie, Technical Supervisor, QA, Baxter, Austria

09.45 Developing stability indicating methodsWhat requirements do you need to consider ahead ofdevelopment?Structured approach to methods developmentSome common issues with stability methodsHow to bring down run times as part of your methoddevelopmentCase study on Fast LC

Mark Benger, Senior Scientist, Aptuit, UK

10.15 Conducting forced degradation studies Forced Degradation Studies (Stress Testing) are essentialrequirements of stability studies. This presentation will discuss:

What are Forced Degradation Studies?What are the regulatory requirements?Design of a suitable protocol for a drug substance studyWhat are the additional requirements for finished products?Provide an example of a drug substance forced degradationstudy

Geoff Carr, Director Analytical Development, Patheon Inc,Canada

10.45 Coffee and morning refreshments

11.15 Worked example: Designing a validation study fora related substances test for a drug productGeoff Carr, Director Analytical Development, Patheon Inc,Canada

12.15 Writing stability protocols Requirements for stability testing of new drug substancesand drug products at all stages of drug developmentDesigning a global stability protocol for global registration,including zones III and IVAn introduction to bracketing and matrixing designs

Lesley Bugg, Team Manager, Pharmaceutical, Analytical R&D,AstraZeneca, UK

13.00 Lunch

14.00 Worked example: Designing a stability protocol In this workshop, groups will represent a Development Team ofa Pharmaceutical Company and will design a stability protocolto achieve registration of a product in the quickest, cheapestand most effective way for the company.Lesley Bugg, Team Manager, Pharmaceutical Analysis,Analytical R&D, AstraZeneca, UK

15.00 Managing impurities and degradation productsthroughout development This presentation will focus on transforming analytical datainto successful specifications and will provide an overview of:

Fundamentals of impurity identification and qualification Regulatory requirements, including recent ICHdevelopments Impurity specifications for clinical trials and registration Setting specifications for degradation products fromstability studies Developing specifications for toxic impuritiesStephen Robinson, Senior Director, PharmaceuticalSciences, Pfizer, UK

16.00 Report back and conclusions of the day

16.30 End of day two and coffee

19.00 Course dinner at the hotel

Sunday 23 April 2006 - Accommodation included and dinner available from 19.30 - 20.30

17.30 Tour of BrightonMingle and network with your course colleagues whilstseeing the sights of the seaside town

Or call our bookings hotline: +44(0)20 7017 5507

ALYSIS COURSE: FROM DISCOVERY TO PRODUCTION

Look at which job titles attended in 2005:

Analyst

Analytical Group Leader

Analytical Specialist

Analytical Team Leader

Associate Researcher

Chemist

Deputy Head of Analytics

Development Scientist

Head of Department

Head of Laboratory

Laboratory Manager

Pharmaceutical Assessor

Principle Scientist

Research Chemist

Researcher

Scientific Associate

Scientist

Senior Analytical Chemist

Senior Research Scientist

Standardisation LaboratoryManager

Validation Analyst

15.30 Worked example: Conducting a laboratoryinvestigation The process of conducting an investigation into an Out of Specification(OOS) result can be complex and time-consuming. At each stage, therecan be several possible actions and many potential outcomes. A flowchart can be helpful to operators responsible for executing OOSinvestigations. In this example the group will design a flow chart for alaboratory investigation, indicating what actions should be taken, in whatorder and with what potential outcomes. The aim is to cover the processfrom finding an OOS result through to failure or impact assessment.Gerry Maxwell, Head of Pharmaceutical Analysis, NDA Analytics,UK

16.30 Report back and conclusions of the day

17.00 End of course

3 excellent reasons to attend:• A perfect opportunity to gain intense grounding or a refresher

in Pharmaceutical Analysis

• Enjoy the seaside delights of Brighton, only a short 50 minutetrain journey from London

• All course materials, accommodation and meals are included inyour course pass

Book now to avoid disappointment, there are only 50places available! www.ibc-lifesci.com/pharmanalysis

DAY THREE: 26 APRIL 2006 | PRODUCTION

08.00 Breakfast

08.45 Welcome to day three from your course leaderGeoff Carr, Director Analytical Development, Patheon Inc, Canada

09.00 Designing quality into a novel product Quality by Design

Drivers for product & process understandingProcess capability, specifications and quality

Case studyDesign specification and Quality by Design approachOptimisation of drug substance propertiesDrug product process assessmentExcipients and drug substancesManufacturing unit operationsProcess Analytical Technologies (PAT)Design of Experiments (DoE)

SummaryLifecycle of a product: The new paradigm

Stephen Robinson, Senior Director, Pharmaceutical Sciences, Pfizer,UK

09.45 Driving innovation in pharmaceutical analysisExamples using separation science and process analyticaltechnologies

Roman Szucs, Associate Research Fellow, Separation Science TeamLeader, Pfizer, UK

10.30 Coffee and morning refreshments

11.00 Panel discussion and Q&A session

11.45 Approaches to in-process sampling and blenduniformity testing for oral dosage forms In-process testing is very important for the control ofpharmaceutical manufacturing operations. For solid oral dosageforms, eg tablets and capsules, this often involves analyses of blendsamples taken by sample thieves and tested for uniformity but inmany cases this has been found to be an unreliable procedure. Thispresentation will discuss:

In-Process testing in support of pharmaceutical manufactureSample thieves and blend uniformity testingWhat is PQRI all aboutFDA Draft Guidance on stratified sample testingCase study example of the use of a stratified sampling approach

Geoff Carr, Director Analytical Development, Patheon Inc, Canada

12.30 Introduction to NIR and chemometricsNear-infrared spectroscopy is nowadays more readily accepted as atechnology for rapid and non-destructive analysis of pharmaceuticalsamples. In the last few years NIR has become an established method forthe quality control of pharmaceutical products and ingredients. This hasonly been possible as the gap to multivariate data analysis has vanished.The dramatic development of powerful low-cost computers and theintensive application of chemometrical methods made it possible tobuild adequate calibrations and models. In this talk the combinationNIR/chemometrics will be illustrated through real life examples.Michel Ulmschneider, Pharmaceutical Quality Control,F. Hoffmann - La Roche Ltd, Switzerland

13.15 Lunch

14.30 Identifying out of specification (OOS) and out oftrend (OOT) results

Review of potential causes of OOS and OOT resultsRegulatory guidance for handling OOS & OOT results (includingrecommendations of the ‘Barr Ruling’)Classification of ‘errors’Conducting a compliant and efficient laboratory investigationConcluding a laboratory investigation – failure investigations, impactassessments & corrective actions

Gerry Maxwell, Head of Pharmaceutical Analysis, NDA Analytics,UK

15.15 Coffee

Look at which countries attended in 2005:

South Africa4%

UK40%

Denmark10%

Germany11%

Italy7%

Slovenia4%Poland

4%Latvia4%

Ireland4%

Hungary4%

Finland4%

Belgium4%

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FEE: This includes all sessions, 3 nights accommodation (Sunday, Monday,Tuesday), all meals, refreshments and documentation. Please note that feesare payable in respect of all reservations made for this event unlesscancellation has been received under the terms stated below.

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Conference Documentation: Cannot Attend? For those busy executives who cannot take advantage ofany of this conference, the papers give you a useful record of the presentations made at this meeting. The setof papers is £299. Simply tick the box on the booking form, send it with payment and your copy will be onits way to you straight after the event. If you are not completely satisfied with the IBC product you receive,simply contact us within 15 days of receipt for a refund or exchange. To order copies or for furtherinformation please contact Customer Services: Tel +44 (0)20 7017 5507, Fax +44 (0)20 7017 4749 oremail: papers.info@informa.com

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■■ Pharmaceutical Analysis Course (24 - 26 April 2006):£1799 + 17.5% VAT** Total = £2114

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