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PAT & QbD brochure (PDF) - JMP

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Presents the 7th Annual<br />

<strong>PAT</strong> and Quality<br />

SAVE up<br />

to £300<br />

register and pay by<br />

30th October 2009<br />

by Design<br />

Two-Day Conference: 19th-20th January 2010<br />

Pre-Conference Workshops: 18th January 2010<br />

Grand Connaught Rooms, London<br />

Drive efficiency and take that next step by establishing a successful<br />

<strong>PAT</strong> and Quality by Design strategy for your entire business<br />

Establish a successful change management<br />

strategy when implementing <strong>QbD</strong> across the<br />

whole business: Novo Nordisk discuss<br />

their strategy and how it’s helping them create a<br />

smoother transition<br />

Effectively apply <strong>PAT</strong> and <strong>QbD</strong> principles to<br />

Biopharmaceuticals: Eli Lilly discuss the<br />

outcomes of an industry consortium with<br />

guidance from the FDA<br />

Cut a clear path to regulatory submission<br />

success: Bristol Myers Squibb discuss how<br />

they succeeded in their <strong>QbD</strong> submission and<br />

how you can do the same<br />

Capture and manipulate real time data<br />

efficiently to support your <strong>PAT</strong>/<strong>QbD</strong> initiatives:<br />

Vertex Pharmaceuticals share their recent<br />

experiences and show you get the most out of<br />

your data<br />

Pre-Conference Workshops<br />

A Application of <strong>PAT</strong> and <strong>QbD</strong> for<br />

Biopharmaceuticals<br />

B De-mystifying Regulatory Submission<br />

for <strong>PAT</strong> and <strong>QbD</strong><br />

www.patandqbd.com<br />

Expert speakers include:<br />

KEYNOTE SPEAKER<br />

Dr Victor A. Vinci, Director, Bioprocess Operations,<br />

Eli Lilly and Company<br />

≥Key Regulatory Insight: Des Makohon, Senior GMP<br />

Inspector, MHRA. Member, <strong>PAT</strong> Team, EMEA<br />

≥Gerald DiDonato, Group Director, Global Regulatory<br />

Sciences CMC,Bristol Myers Squibb<br />

≥Michael Schousboe, Expert, Manufacturing Science and<br />

Quality, Novo Nordisk<br />

≥Martin Warman, Scientific Fellow, Analytical Development,<br />

Vertex Pharmaceuticals<br />

≥David Sharp, Senior Principal Scientist, Pfizer<br />

≥Hans ter Maat, Senior Process Engineer, DSM Biologics<br />

≥Zadeo Cimarosti, Manager, Chemical Development,<br />

GlaxoSmithKline Verona Italy<br />

≥Philippe Cappuyns, Pharmaceutical Technology Director,<br />

Janssen Pharmaceutica<br />

≥Dr Hedinn Valthorsson, Manufacturing Manager, Novartis<br />

≥Dr Barry Gujral MBA, Associate Director, Quality<br />

Engineering, Noven Pharmaceuticals Inc.<br />

≥Ayub Khan, Senior Process Technologist, Napp<br />

Pharmaceuticals<br />

≥Branko Vranic, PhD Student and Teaching Assistant,<br />

Industrial Pharmacy Lab, University of Basel<br />

≥Professor Julian Morris, Technical Director, CPACT<br />

≥Petter Morree, Director, Online Products, Umetrics AB<br />

≥Peter Amanatides, Vice President QA and QC, Noven<br />

Pharmaceuticals Inc.<br />

≥Martin Owen, Manager, GlaxoSmithKline UK<br />

≥Dr Per Vase, Senior Specialist, Consulting, NNE Pharmaplan<br />

≥Patrick Bossuyt, SI<strong>PAT</strong> Sales Executive, SIEMENS<br />

Session<br />

Sponsors<br />

Gold<br />

Exhibitor<br />

Media<br />

Partners<br />

CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk


Pre-Conference Workshops: 18th January 2010<br />

Workshop A: 10.00-13.00<br />

Application of <strong>PAT</strong> and <strong>QbD</strong> for Biopharmaceuticals<br />

With <strong>PAT</strong> and <strong>QbD</strong> having a more established hold within the small molecules arena the focus is now turning towards the<br />

more complex Biopharmaceutical sector. This interactive workshop will discuss the different stages and important<br />

considerations focusing on the practical application of <strong>PAT</strong> and <strong>QbD</strong> principles for drug design and manufacture. Attendees<br />

will have the chance to discuss case study examples as well as work within smaller groups for more targeted discussions.<br />

Workshop Leader: Dr Victor A. Vinci, Director, Bioprocess Operations, Eli Lilly and Company<br />

Meet your workshop leader<br />

Dr. Vinci is currently Director of Bioprocess Operations at Eli Lilly and Company in Indianapolis, Indiana. As such,<br />

he is responsible for process operations focused on bringing new protein therapeutics to market by producing<br />

active pharmaceutical ingredients intended for clinical trials. For the last 4 years, his responsibilities have<br />

included coordination of teams involved in the design, commissioning and qualification of a new 200,000 sq ft<br />

cGMP bulk process facility, developing staffing models, and implementing effective and compliant operational<br />

practices. His team is currently engaged in tech transfer for new campaigns, bioprocess operations to produce<br />

bulk biologic API, and improving platform operations for bioproducts. He serves as the lead for the Lilly team involved with<br />

the CMC Biotech Working Group (industry consortium) which has finished a <strong>QbD</strong> case study for a monoclonal antibody (Mab).<br />

Prior to his current role, he was a scientist and group leader in process development at Eli Lilly for five years. He began his<br />

career at Merck where he was a scientist and later section head in an Manufacturing Science and Technology (MS&T) role.<br />

Dr. Vinci received his doctorate in Microbiology from The Ohio State University in 1988.<br />

Workshop B: 14.00-17.00<br />

De-mystifying Regulatory Submission for <strong>PAT</strong> and <strong>QbD</strong><br />

This interactive workshop will allow you to assess successful and unsuccessful FDA and EMEA submissions as well as<br />

giving attendees the opportunity to discuss openly their own experiences and gather fresh ideas on how they can change<br />

their approach for the better.<br />

Workshop Leader: Gerald DiDonato, Associate Director, Global Regulatory Sciences CMC, Bristol Myers Squibb<br />

Meet your workshop leader<br />

Gerald DiDonato, Associate Director, Global Regulatory Sciences-CMC, received his PhD in Analytical Chemistry with a<br />

specialty in mass spectrometery from Indiana University in 1987. Gerald joined Bristol-Myers Squibb as a Research<br />

Investigator solving structure elucidation problems for Discovery, Development and Manufacturing colleagues. He was one<br />

of the first to use electrospray mass spectrometry as a routine structure elucidation tool in the Pharmaceutical Industry.<br />

Subsequently he managed multidisciplinary analytical groups, and led Development and Manufacturing Teams for new<br />

products. Gerald recently chaired the Company's Specification Committee. He saw the light and switched to Regulatory<br />

Affairs in 2005, where he currently is the CMC lead for saxagliptin as well as several products in development.<br />

About Pharma IQ<br />

Become a member of Pharma IQ and receive complimentary access to resources that will<br />

keep you at the forefront of industry change. You will receive access to our growing<br />

library of multi-media presentations from industry leaders, an email newsletter updating<br />

you on new content that has been added, free aggregated news feed from over 1000<br />

global news sources tracking your industry and special member only discounts on events.<br />

Become a member here: Web: www.pharmaceuticaliq.com Phone: +1-646-454-4559<br />

www.patandqbd.com<br />

CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk


Conference Day One: 19th January 2010<br />

08.50 Pharma IQ Welcome and Chairperson’s Opening<br />

Address<br />

09.00 Opening Presentation: EU Regulatory<br />

Perspective of <strong>PAT</strong> Technology and Inspections<br />

Visit www.patandqbd.com for updates<br />

Des Makohon, Senior GMP Inspector, MHRA.<br />

Member, <strong>PAT</strong> Team, EMEA<br />

09.45 Case Study: Filing a <strong>QbD</strong> Submission Across the<br />

Globe<br />

• Outline of the product (saxagliptin, trade name<br />

Onglyza) and the joint file process<br />

• Highlighting the problem areas experienced<br />

throughout the application process<br />

• How were these challenges approached and<br />

overcome? Analysing the feedback from the<br />

different regulatory authorities across the globe<br />

Gerald DiDonato, Associate Director, Global<br />

Regulatory Sciences CMC, Bristol Myers Squibb<br />

10.30 Process Understanding: The Key to a<br />

Successful <strong>QbD</strong> or <strong>PAT</strong> Implementation.<br />

To properly design quality into your product you<br />

need to understand the relation between functional<br />

requirements and design parameters. At the same<br />

time, the relationship between the design parameters<br />

and process parameters provides the basis to<br />

properly control the manufacturing process used to<br />

realize your product design. <strong>QbD</strong> combines both aspects,<br />

and holds the promise of reduced time to market and<br />

increased market share. In this session you will:<br />

• See how Design of Experiments (DoE) allows you<br />

to rapidly gain secure knowledge of the two<br />

types of relationships fundamental to <strong>QbD</strong>.<br />

• Discover how easy to use software packages,<br />

like <strong>JMP</strong> from SAS, have made DoE a tool for<br />

engineers, not just for statisticians.<br />

• See several real-world examples of the use of<br />

DoE within <strong>QbD</strong> initiatives in the pharmaceutical<br />

and biotech industry<br />

Dr Per Vase, Senior Specialist, Consulting, NNE<br />

Pharmaplan<br />

10.50 Networking Coffee Break<br />

11.20 Multivariate Statistical Process Control: Moving<br />

Towards Model Based Approaches<br />

• The challenges of capturing, analysing and<br />

monitoring with real time dynamic data<br />

• Understanding why process dynamics and<br />

dynamic multivariate monitoring are important to<br />

assured pharmaceuticals development and<br />

manufacturing<br />

• Analysing the role of dynamics in <strong>PAT</strong> and <strong>QbD</strong><br />

in achieving RTR<br />

• Increasing process understanding using<br />

advanced <strong>PAT</strong> tools<br />

Professor Julian Morris, Technical Director, CPACT<br />

12.00 Ensuring Efficient <strong>QbD</strong> and <strong>PAT</strong> Implementation<br />

<strong>PAT</strong> and <strong>QbD</strong> has left the initial phase and the<br />

question that companies face now is how to<br />

implement <strong>PAT</strong> and <strong>QbD</strong> in an efficient way rather<br />

than if it is possible.<br />

Umetrics will talk about common themes in projects<br />

which have reached their goals within the given<br />

timeframe and budget including:<br />

• The importance and use of risk analysis, FMEA<br />

• Understanding when and how to employ<br />

multivariate methodology<br />

• The benefits of involving QA at an early phase to<br />

avoid delays in the implementation and<br />

validation phase<br />

Examples range from DoE based development<br />

projects all the way to validated multivariate<br />

on-line installations.<br />

Petter Morree, Director, Online Products,<br />

Umetrics AB<br />

12.45 Networking Lunch Break<br />

14.00 Case Study: Using NIR <strong>PAT</strong> Application to<br />

Reduce Risk of Scale-Up<br />

This case study will demonstrate how a simple <strong>PAT</strong><br />

application reduced the risk to critical Quality<br />

Attributes of scaling up a Unit Dose process<br />

Ayub Khan, Process Technologist, Napp<br />

Pharmaceuticals<br />

14.45 Case Study: Robust Method for the<br />

Determination of Caffeine in Intact Tablets by<br />

Near-infrared Spectroscopy<br />

• Development of a method for the determination<br />

of caffeine in intact tablets<br />

• Effect of the sample size on the predictive<br />

ability of the developed calibration model<br />

• Effect of the sample variance<br />

(variable compression force) on the predictive<br />

ability of the developed calibration model<br />

• Comparison between diffuse reflectance and<br />

diffuse transmittance NIR sampling<br />

Branko Vranic, PhD Student and Teaching Assistant,<br />

Industrial Pharmacy Lab, University of Basel<br />

15.30 Networking Coffee Break<br />

16.00 Gathering Data to Support <strong>QbD</strong><br />

• Importance of Product Definition and Process Mapping<br />

• Risk assessment process: Subjective vs. statistical<br />

data, use of FMEA and Cause+Effect Matrix<br />

• Use of measurement systems to gather data<br />

during DoE: Measured vs. Measurement Variance<br />

• Use of <strong>PAT</strong> to drive process control<br />

Martin Warman, Scientific Fellow, Analytical<br />

Development, Vertex Pharmaceuticals<br />

16.45 Case Study: Application of <strong>QbD</strong>/<strong>PAT</strong> on a<br />

Commercial Product: Quality by Re-Design<br />

• The reason why we are trying to implement <strong>PAT</strong><br />

will also be shown to be the handling of the<br />

incoming variability in order to deliver predefined<br />

quality each and every time<br />

• The utilisation of Quality Risk Management tools<br />

for finding the Critical Process Parameters. This<br />

includes Fishbone diagrams and FMEA’s<br />

• Why IT and Automation infrastructure are<br />

necessary for using MVDA during manufacturing<br />

• Outlining the need for MVDA in manufacturing<br />

as a confirmation of the established design<br />

space will be described<br />

Dr Hedinn Valthorsson, Manufacturing Manager,<br />

Novartis<br />

17.30 Break-Out Round Table Discussions<br />

Participants will be able to choose between the<br />

different roundtables and spend 45 minutes<br />

discussing the points outlined below before<br />

feeding back to the group<br />

A: The Use of Lean and Six Sigma Initiatives with<br />

<strong>PAT</strong> when Striving for Operational Excellence<br />

Martin Warman, Scientific Fellow, Analytical<br />

Development, Vertex Pharmaceuticals<br />

B: Successfully Using Quality Risk Management to<br />

Establish CQAs<br />

Zadeo Cimarosti, Manager, Chemical Development,<br />

GlaxoSmithKline Verona, Italy<br />

C: Should You Build in <strong>QbD</strong> Before or After Proof of<br />

Concept<br />

Michael Schousboe, Senior <strong>QbD</strong> Manager,<br />

Manufacturing Science and Quality, Novo Nordisk<br />

D: Successfully Creating and Controlling a Secure<br />

Design Space<br />

Dr Barry Gujral MBA, Associate Director, Quality<br />

Engineering, Noven Pharmaceuticals Inc.<br />

E: How to Approach <strong>QbD</strong> in Biopharmaceuticals<br />

Victor A. Vinci, Director, Bioprocess Operations,<br />

Eli Lilly and Company<br />

18.30 Chairperson’s Closing Remarks and Close of Day One<br />

CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk


Conference Day Two: 20th January 2010<br />

08.45 Chairperson’s Opening Remarks<br />

08.55 KEYNOTE PRESENTATION<br />

Case Study: Development of a Monoclonal<br />

Antibody Using <strong>QbD</strong>: Results from the Industry<br />

Consortium<br />

• Overview of the case study describing<br />

monoclonal antibody development from molecule<br />

design through validation<br />

• Examples of risk assessment strategy and tools used<br />

• Examples of the use of prior platform knowledge<br />

and experimental design for mammalian cell<br />

culture and protein purification<br />

• The analysis leading toward critical quality<br />

attributes (CQAs) and control strategy<br />

• A proposal for design space and lifecycle<br />

management of the process and product<br />

Dr Victor A. Vinci, Director, Bioprocess<br />

Operations, Eli Lilly and Company<br />

09.40 Using <strong>QbD</strong> Approaches to Enable Development<br />

of Real-Time-Release for a Continuous Drug<br />

Product Process<br />

• Discussion of the <strong>QbD</strong> risk management<br />

approaches used at Pfizer<br />

• Generation of process understanding and design<br />

space capable of supporting a <strong>QbD</strong> filing<br />

• Moving from batch processing to continuous<br />

processing for Pharmaceutical drug products<br />

• Implementation of CQV and RTR in<br />

pharmaceutical manufacturing at Pfizer<br />

David Sharp, Senior Principal Scientist, Pfizer<br />

10.20 Business Case on the use of <strong>PAT</strong> in an Oral<br />

Solid Dosage Pilot Plant<br />

• Outlining a successful <strong>PAT</strong> implementation in an<br />

Oral Solid Dosage Pilot Plant<br />

• Overcoming some of the key challenges in<br />

putting a <strong>PAT</strong> strategy into practice<br />

• Discussion of how <strong>PAT</strong> has contributed towards<br />

cost saving objectives by helping speed up the<br />

development process and shorten the production<br />

time<br />

Patrick Bossuyt, SI<strong>PAT</strong> Sales Executive, SIEMENS<br />

11.00 Networking Coffee Break<br />

11.30 Case Study: Developing a Successful Change<br />

Management Approach When Implementing<br />

<strong>QbD</strong> in a Global Company<br />

• How do you approach implementing new<br />

concepts like <strong>QbD</strong> within the wider business<br />

• Overcoming the challenge of change by<br />

illustrating the benefits and securing buy in.<br />

• Ensuring the business keeps running with both<br />

current and new paradigm’s during implementation<br />

• Preparing for when <strong>QbD</strong> is part of how we run<br />

the business<br />

Michael Schousboe, Senior <strong>QbD</strong> Manager,<br />

Manufacturing Science and Quality, Novo Nordisk<br />

12.10 Case Study: Application of <strong>QbD</strong> in Development:<br />

Building the Control Strategy for Drug<br />

Substance Critical Quality Attributes in the<br />

Manufacturing Process of a Drug Substance<br />

The quality by design approach adopted for the<br />

definition of the control strategy for a drug in<br />

development is described. Details are given on:<br />

• The risk assessment done to identify the<br />

potential quality critical process parameters<br />

• The multivariate and univariate process studies<br />

undertaken to assess the potential quality<br />

critical process parameters<br />

• The specification controls on the input materials<br />

All these elements of control combined together,<br />

allowed the definition of a robust control<br />

strategy with the potential to remove the “endproduct<br />

testing” for some drug substance-CQAs.<br />

Zadeo Cimarosti, Manager, Chemical<br />

Development, GlaxoSmithKline Verona, Italy<br />

12.50 Panel Discussion: Integrating <strong>QbD</strong> principles<br />

into your Lifecycle Management Programme<br />

• Discussing the benefits of integrating the two<br />

initiatives<br />

• How can this actually be done? What are the<br />

first few steps?<br />

David Sharp, Senior Principal Scientist, Pfizer<br />

Zadeo Cimarosti, Manager, Chemical<br />

Development, GlaxoSmithKline Verona, Italy<br />

Michael Schousboe, Senior <strong>QbD</strong> Manager,<br />

Manufacturing Science & Quality, Novo Nordisk<br />

Philippe Cappuyns, Pharmaceutical Technology<br />

Director, Janssen Pharmaceutica<br />

13.20 Networking Lunch Break<br />

14.20 Case Study: Developing a Strong Business Case<br />

for <strong>QbD</strong> Implementation Within a Contract<br />

Manufacturing Company<br />

• Outlining the challenges faced by a CMO<br />

• Discussing the benefits of using <strong>QbD</strong> in<br />

customer projects<br />

• Highlighting some of the difficulties faced and<br />

how these were overcome<br />

Hans ter Maat, Senior Process Engineer, DSM Biologics<br />

15.00 Case Study: Model-based <strong>QbD</strong> Development<br />

Integrated in a Product Life Cycle Management<br />

Approach<br />

• The presentation will provide a systematic and<br />

proactive <strong>QbD</strong> development approach enabling to<br />

meet current ICH Q8, Q9 and Q10 guidelines<br />

• The characteristics of a model-based <strong>QbD</strong><br />

development methodology and the resulting<br />

benefits will be highlighted<br />

• The presentation will cover the integration of<br />

<strong>QbD</strong> into a Product Life Cycle Management<br />

approach and its business value<br />

Philippe Cappuyns, Pharmaceutical Technology<br />

Director, Janssen Pharmaceutica<br />

15.40 Networking Coffee Break<br />

16.10 Case Study: Delivering Robust Manufacturing<br />

Processes Using a Structured Critical Process<br />

Parameter workflow<br />

• Exemplification of the GSK API critical process<br />

parameter workflow<br />

• Workflow essentials: Planning, process<br />

understanding, performance, uncertainty, risk<br />

and control<br />

• Making it happen, adding value<br />

Martin Owen, Manager, GlaxoSmithKline<br />

16.50 Case Study: Implementing <strong>PAT</strong> and <strong>QbD</strong> at the<br />

Formulation Stage<br />

• Outline the challenges faced when implementing<br />

these tools earlier in the life cycle<br />

• Discussion of key examples used in transdermal<br />

drugs<br />

• Risk analysis study using these tools<br />

• Comparison of predictive and observed results<br />

Dr Barry Gujral MBA, Associate Director, Quality<br />

Engineering, Noven Pharmaceuticals Inc.<br />

Peter Amanatides, Vice President QA and QC,<br />

Noven Pharmaceuticals Inc.<br />

17.30 Chairperson’s Final Remarks and Close of<br />

Conference<br />

CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk


Session Sponsor<br />

Conference Sponsors<br />

Session Sponsor<br />

Session Sponsor<br />

Umetrics – Value from Data. Since 1987, Umetrics' mission<br />

has been to ensure that clients add value to their businesses<br />

through the use of advanced data analysis and experimental<br />

design software and services. Umetrics is the worldwide<br />

recognized leader in the area of multivariate data analysis for<br />

industrial R&D, processes, <strong>PAT</strong>, <strong>QbD</strong> and applications.<br />

Umetrics customers have proven many times that the use of<br />

Umetrics technology and services have generated significant<br />

added value by optimizing processes through generation of<br />

reliable information from complex data.<br />

Umetrics offers a complete solution for <strong>PAT</strong> and <strong>QbD</strong><br />

applications in the area of Design of Experiments and<br />

Multivariate Data Analysis. Our offering to industry covers<br />

software products for model building and troubleshooting to<br />

real-time software solutions for process monitoring and<br />

control enabling e.g. RTR – Real Time Release. Training<br />

services, support and projects are important parts of our<br />

offering. Umetrics train more than 1000 scientists and<br />

engineers per year in DoE and MVDA. Umetrics have offices<br />

in US *3, UK, Sweden*2, Singapore and Japan.<br />

Phone: +46 40 664 25 80<br />

Fax: +46 40 664 25 85<br />

Email: info@umetrics.com<br />

Web: www.umetrics.com<br />

Gold Exhibitor<br />

Büchi is a privately held company in the eastern part of<br />

Switzerland. It was founded in 1939 as a glass blowing<br />

workshop. High-tech glass instruments for the use in<br />

chemical laboratories are still one of the core<br />

competencies of Büchi.<br />

In the meantime, Büchi is a world-wide supplier in key<br />

technologies such as evaporation and separation for<br />

research laboratories as well as near infrared<br />

spectroscopy and reference methods for quality control<br />

purposes.<br />

From ergonomic laboratory equipment to the solution of<br />

complex analytical problems in the high-tech sector, Büchi<br />

provides practical support in the chemical laboratory. And<br />

in its own research and development laboratory, Büchi<br />

works constantly on solutions for customer problems in<br />

the areas of Nutrition, Life Sciences and production in the<br />

pharmaceutical and chemistry related industry.<br />

Phone: +41 71 394 63 63<br />

Fax: +41 71 394 65 65<br />

Email: info@buchi.com<br />

Web: www.buchi.com<br />

Siemens Industrial IT develops and implements<br />

software solutions in the domains specification<br />

management (PLM), lab and quality management<br />

(LIMS), MES, PIMS, SCADA, EPMS and metering.<br />

Our offering includes a solution for <strong>PAT</strong> and <strong>QbD</strong> in<br />

the pharmaceutical industry, based on SI<strong>PAT</strong>.<br />

This software solution has been developed in<br />

close cooperation with the FDA to support <strong>PAT</strong><br />

implementation efforts and the use of <strong>PAT</strong> tools in<br />

development and manufacturing.<br />

It is successfully operational at GSK, Merck, Wyeth<br />

and Ferring.<br />

What is SI<strong>PAT</strong> ?<br />

• SI<strong>PAT</strong> increases process understanding and<br />

allows continuous process improvement during<br />

manufacturing operations and process<br />

development.<br />

• SI<strong>PAT</strong> enables monitoring and consolidation of<br />

product quality information, allowing real-time<br />

quality decision making<br />

• SI<strong>PAT</strong> enables (advanced) process control<br />

whereby it can either focus on specific Unit<br />

operations or it can cover total batch quality to<br />

enable Real-time Product Release.<br />

• SI<strong>PAT</strong> serves as the common interface for all<br />

<strong>PAT</strong> tools.<br />

Web: www.swe.siemens.com/belux/sipat/en<br />

<strong>JMP</strong> is a business unit of SAS Institute, the largest privately held software company with revenues exceeding 2 Bn$. <strong>JMP</strong> and <strong>JMP</strong> Genomics are<br />

software products that allow scientists, engineers, and business users to easily get value from their data through “statistical discovery”. <strong>JMP</strong> has been<br />

under development for 20 years, and is used globally.<br />

Web: www.jmp.com<br />

Testimonials<br />

“Really enjoyed the case examples when a good level of detail was presented. Has been very useful to<br />

understand current status as perceived by industry & network with colleagues.”<br />

Andy Townsend, AstraZeneca<br />

“Very good. Good update and information on current state of <strong>QbD</strong> & <strong>PAT</strong>. A good general overview of<br />

what design space is to pharma.”<br />

Steven Brown, Wyeth<br />

Sponsorship Opportunities<br />

Sponsoring the 7th Annual <strong>PAT</strong> and Quality By Design Forum will deliver:<br />

1. Networking opportunities enabling you to sell directly to, and meet with, key budget holders who had<br />

invested considerable time and money to attend this event and address their business challenges<br />

2. A platform from which to demonstrate your technology and thought-leadership to your target market<br />

3. Brand awareness amongst your target market, keeping your company front of mind for both your<br />

current and prospective clients<br />

Pharma IQ’s 7th Annual <strong>PAT</strong> and <strong>QbD</strong> event deals with the current challenges and success stories from within the<br />

pharmaceutical arena, bringing together the key decision makers and innovative minds within the field.<br />

Contact Gal Cohen on +44 (0) 20 7368 9300 or sponsorship@iqpc.co.uk and she will be able to discuss with you<br />

your business goals and how we can help you achieve them<br />

CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk


7th Annual <strong>PAT</strong> and Quality by Design<br />

Two-Day Conference: 19th-20th January 2010 Pre-Conference Workshops: 18th January 2010 Venue: Grand Connaught Rooms, London<br />

REGISTRATION FORM<br />

To speed registration, please provide the priority code located on the mailing label or in the box below.<br />

My registration code is <strong>PDF</strong>W<br />

B<br />

Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration code above to inform<br />

us of any changes or to remove your details.<br />

5 WAYS TO REGISTER<br />

Freephone: 0800 652 2363 or +44 (0)20 7368 9300<br />

Fax: +44 (0)20 7368 9301<br />

Post:<br />

your booking form to<br />

IQPC Ltd. Anchor House, 15-19 Britten<br />

Street,London SW3 3QL<br />

Online:<br />

www.patandqbd.com<br />

Package<br />

Silver Package<br />

Two-Day Conference<br />

+ 2 Workshops<br />

Book and pay before<br />

30 October 2009*<br />

Save £300<br />

£2197 + VAT<br />

Book and pay before<br />

4 December 2009*<br />

Save £200<br />

£2297 + VAT<br />

Standard Price<br />

£2497 + VAT<br />

Email:<br />

TEAM DISCOUNTS<br />

enquire@iqpc.co.uk<br />

IQPC recognises the value of learning in teams. Groups of 3 or more booking at the<br />

same time from the same company receive a 10% discount. 5 or more receive a<br />

15% discount. 7 receive a 20% discount. Only one discount available per person.<br />

Conference No: 11287.004<br />

Bronze Package<br />

Two-Day Conference<br />

+ 1 Workshop**<br />

Conference Only<br />

Two-Day Conference<br />

*Only one discount is applicable per person. In order to qualify for the discounts, payment must be received by the booking<br />

deadlines. Team discounts are applicable to standard prices.<br />

**Please tick. I would like to register for workshop(s):<br />

A Application of <strong>PAT</strong> and <strong>QbD</strong> for Biopharmaceuticals<br />

B De-mystifying Regulatory Submission for <strong>PAT</strong> and <strong>QbD</strong><br />

DELEGATE DETAILS<br />

Please photocopy for each additional delegate<br />

DELEGATE 1<br />

Mr Mrs Miss Ms Dr Other<br />

First Name<br />

Family Name<br />

Department<br />

Position<br />

Tel No.<br />

Email<br />

Yes I would like to receive information about products and services via email<br />

Organisation<br />

Nature of business<br />

Address<br />

Postcode Country<br />

Telephone<br />

Fax<br />

Dept. Head Title<br />

Name of person completing form if different from delegate:<br />

Signature<br />

I agree to IQPC’s cancellation, substitution and payment terms<br />

Special dietary requirements: Vegetarian Non-dairy Other (please specify)<br />

Please indicate if you have already registered by Phone Fax Email Web <br />

Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking.<br />

PAYMENT METHODS<br />

Total price for your Organisation: (Add total of all individuals attending):<br />

Card Number:<br />

VISA MASTERCARD AMEX <br />

<br />

Exp. Date: Sec: <br />

Name On Card:<br />

Billing Address (if different from above):<br />

Save £200<br />

£1798 + VAT<br />

Save £100<br />

£1399 + VAT<br />

Save £100<br />

£1898 + VAT<br />

Signature:<br />

£1998 + VAT<br />

£ 1499 + VAT £ 1499 + VAT<br />

City/County/Postcode: Cheque enclosed for: £ (Made payable to IQPC Ltd.)<br />

(Please quote 11287.004 with remittance advice)<br />

IQPC Bank details: HSBC Bank, 67 George Street, Richmond, Surrey, TW9 1HG. United Kingdom.<br />

Sort Code: 40 38 18, Account No: 51304143, IBAN Code: GB59 MIDL 4038 1851 3041 43 Swift Code: MIDLGB2112V<br />

Account name: International Quality & Productivity Centre Ltd.<br />

PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE<br />

VENUE & ACCOMMODATION<br />

VENUE:<br />

Grand Connaught Rooms, 61 - 65 Great Queen Street, Covent Garden, London WC2B<br />

5DA.Tel: +44 (0)20 7405 7811<br />

ACCOMMODATION:<br />

Accommodation is not included in the registration fee. To book nearby<br />

accommodation, for Strand Palace Hotel, 372 The Strand, London, WC2R 0JJ,<br />

please click on to www: https://secure.strandpalacehotel.co.uk/v1web/ When<br />

making online bookings please use Corporate ID GA1. Or call 0207 379 4737,<br />

Always quote booking reference IQPC. Rates start from £95.00 inc vat & Breakfast.<br />

For further nearby accommodation search: www.4cityhotels.com<br />

FREE ONLINE RESOURCES<br />

Our website has changed! You will now find a variety of resources such as articles,<br />

news, podcasts and presentations available online. Many of these features are exclusive<br />

to IQPC so visit www.patandqbd.com today and learn something new for free.<br />

DIGITAL CONFERENCE ON CD ROM<br />

A digital version of the conference proceedings, including all the presentations in<br />

audio format "An excellent service, an invaluable reference tool, easy to access<br />

and easy to store - all in all a top product"<br />

Recent digital conferences available - £599 plus VAT each<br />

Polymorphism and Crystallisation, March 2009<br />

Operational Excellence in Pharmaceutical, Biotech and Medical Devices,<br />

December 2009<br />

Pharmaceutical Amorphous Materials, September 2009<br />

Pharmaceutical Co-Crystals, September 2009<br />

Please send me conference materials indicated above.<br />

I have filled out credit card details below<br />

For further information<br />

Please call: 0207 368 9300 or email: knowledgebank@iqpc.co.uk.<br />

To search IQPC’s archived conference documentation<br />

visit: www.iqpcknowledgebank.com<br />

TERMS & CONDITIONS<br />

PAYMENT TERMS Payment is due in full upon completion and return of the registration form.<br />

Due to limited conference space we advise early registration and payment by credit card to avoid<br />

disappointment. Your registration will not be confirmed until payment is received. Admission to<br />

the conference will be refused if payment has not been received. Payment of invoices by means<br />

other than credit card, or purchase order (UK Plc and Government bodies only) will be subject to a<br />

£49 (plus VAT) processing fee.<br />

CANCELLATION AND SUBSTITUTION POLICY Provided the fee has been paid in full,<br />

substitutions at no extra charge can be made up to 7 business days before the start of the<br />

conference. Cancellations must be received in writing or by fax to +44 (0)20 7368 9301, more<br />

than 7 days before the conference is to be held in order to obtain a full credit for any future<br />

conference. Cancellations received 7 days or less (including the seventh day) prior to the<br />

conference will not be credited. In the event that IQPC cancels an event payments received at<br />

the cancellation date will be credited towards attendance at a future conference, or in the event<br />

of postponement by IQPC, a rescheduled date. Credit notes remain valid for twelve months.<br />

IQPC reserves the right to postpone or cancel an event, to change the location of an event or to<br />

alter the advertised speakers for an event. IQPC is not responsible for any loss or damage as a<br />

result of substitution, alteration, postponement, or cancellation of an event due to causes<br />

beyond its control including without limitation, acts of God, natural disasters, sabotage,<br />

accident, trade or industrial disputes, terrorism, or hostilities. SPEAKER CHANGES<br />

Occasionally it is necessary for reasons beyond our control to alter the content and timing of the<br />

programme or the identity of the speakers<br />

DATA PROTECTION Personal data is gathered in accordance with the Data Protection Act 1998.<br />

Your details may be passed to other companies who wish to communicate with you offers<br />

related to your business activities. If you do not wish to receive these offers, please tick the box<br />

below.<br />

Please do not pass my information to any third party<br />

© IQPC Ltd. 2009 UK VAT is charged at 15% (UK VAT No. GB799225967).

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