PAT & QbD brochure (PDF) - JMP
PAT & QbD brochure (PDF) - JMP
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).