PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOPTuesday 19th July 2011, Grand Copthorne Waterfront Hotel, Singapore

Selection and Processing of Packaging Components Hosted by Sok Tiang, Regional Marketing Director,

West Pharmaceutical Services Singapore 1.30pm - 5.00pm

asia.pre-filled-syringes.com Register online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +65 664 990 94 or +44 (0) 870 9090 712 or call +65 664 990 95/96 or +44 (0) 870 9090 711

Dr Vinod VilivalamDirector of Strategic Market and Technical DevelopmentWest Pharmaceutical Services

Takao IshidaQuality Assurance / CMCBiogen Idec Japan Ltd

Dipankar KaulAuditor (GMP) for API’s, Formulations and Medical DevicesSanofi-Aventis

William McDanielDirector/Team Leader, Global External Supply - Biotech EmergingMarketsPfizer Global

Sunil S. GhogreSenior Director/Team Leader, Global External SupplyPfizer Asia Region

A.P. RajaBusiness Head – Emerging Markets (International Operations)AXA Parenterals

Stefan SundströmTechnical Lead, Sterile Manufacturing, Global Engineering & TechnologyAstraZeneca

Dr. Ghulam MoinuddinAsst. General Manager - Drugs Regulatory Affairs, Head QA-Preclinical and ClinicalVenus Remedies Limited

KEY SPEAKERS INCLUDE:

SMi present their annual conference on...

Pre-Filled Syringes Asia PacificExpanding Strategies for the Emerging Market

Wednesday 20th & Thursday 21st July 2011Grand Copthorne Waterfront Hotel, Singapore

SMi's Pre-Filled Syringes AsiaPacific conference provides afundamental analysis of the keygrowth drivers in the Asia-Pacificmarket. Bringing together theindustry's leading figures, thisevent focuses on the opportunitiesand barriers when creatingsuccessful strategies in thisemerging market.

KEY BENEFITS OF ATTENDING• Discover the commercial opportunities in the emerging PFS Asian market • Understand the current market considerations in selection of packaging components • Meet the growing demand for PFS in local manufacturing• Get to grips with regulatory trends and experiences • Combat contamination risks with sterile manufacturing

Register by March 31st and receive a $300 discountRegister by April 28th and receive a $100 discount

Sponsored by

Register online at asia.pre-filled-syringes.com • Alternativel

Pre-Filled Syringes Asia-PacificDay One | Wednesday 20th July 2011 asia.pre-filled

Supported by

Sponsored by

The OPTIMA GROUP pharma with the long established brands of inova, Kugler and Klee, offer a comprehensive, cutting-edge rangeof products and services. This includes the filling and packaging of pharmaceutical liquids and powders, as well as up anddownstream processing, freeze dryers and automatic loading systems. Combined production and packaging lines formedical/pharmaceutical products as well as automation and laboratory processes are also part of the portfolio. The OPTIMA GROUPpharma is located in Schwaebisch Hall, in the southern part of Germany. www.optima-packaging-group.de/pharma/

With more than 50 years’ experience in the medical device arena, Owen Mumford is a specialist in the design, development &manufacture of automatic systems for self-injection. These include single dose & multi dose reusable & disposable autoinjectors &pen systems, which are suitable for a wide range of primary containers, including pre-filled glass & plastic syringes and pre-filledcartridges. Designed to meet the individual needs of our partners & those of varying user groups, these systems facilitate ease of useand improve safety and patient compliance. www.owenmumford.com

R+E Automationstechnik GmbH is a global player in tailor-maid automation and offers its customers a comprehensive range ofservices in its role as a system supplier. R+E is focussed mainly on the pharmaceutical market with its special requirements and hasmore than 20 years experience in needle bonding machines for prefilled syringes with stacked needles. www.re-automation.de

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksDipankar Kaul, Auditor (GMP) for API's, Formulations and MedicalDevices, Sanofi-Aventis

ASIAN MARKET OVERVIEW

9.10 COMMERICAL OPPORTUNITEIS IN THE PRE FILLED SYRINGES ANDDEVICES ASIAN MARKET• Growth drivers in the parenteral and pre-filled syringes market• Developing future strategies for parenterals and PFS• Utilising the commercial opportunities in PFS drug deliveryA.P. Raja, Business Head – Emerging Markets (InternationalOperations), AXA Parenterals

9.50 Production processes and machinery: Trends and overview in Asia Pacific• Trends in processing pre-filled syringes• In process weighing control for prefilled syringes - what is available

on the market• Transition to vials: the true cost of production• New developments - syringe filling machines Dale Charlton, Director of Business Development, Optima GroupPharma

10.30 Morning Coffee

NEW DEVELOPMENTS

11.00 Recent Trends in Plastic Prefillable Syringe and Vial Systems forBiopharmaceutical Drug DeliveryCyclic olefin polymers and Flurotec elastomers• Recent trends in the use of newer plastics for delivering mAbs,

proteins and vaccines.• Solve challenges associated with glass prefilled syringes, including

breakage and the reactivity and leachables like silicone, tungstenand glue.

• Market and scientific needs for plastic prefillable syringes forbiopharmaceutical drugs and high viscosity formulations.

• Plastic vials for break resistant, less reactive and cold temperaturestorage/transport containers for biologics and stem cells.

Vinod D. Vilivalem, Director of Strategic Market and TechnicalDevelopment, West Pharmaceutical Services

QUALITY CONTROL

11.40 Assuring Safety & Quality of Pre-filled syringesImplementing Pharma Quality Management• Material, design and construction of pre-filled syringes.• Manufacturing & filling process : Influences and Needs for Glass

and Polymer based pre-filled syringes• Primary container compatibility, extractable and leachable studies• Interaction between the primary container system and the injection

device• Structuring the Quality SystemDipankar Kaul, Auditor (GMP) for API’s, Formulations and MedicalDevices, Sanofi-Aventis

12.20 Networking lunch

1.50 Challenges in ensuring quality and patient safety in PFS• Reducing contamination risks in multi-viral doses• Quality assurances: What can we learn from Europe and the US• Analysing risks in pre-filling for devices• Safety issues: Preparation of drugs at the bedside vs. prefilled

syringesMichael Crockett, Principle, Crockett Biotech Consulting

BIOTECHNOLOGY

2.30 Biotechnology and Pre-Filled Syringes • Biologics Manufacturing• Process Engineering • Transfer manufacturing process between clinical and commercial

facilitiesAdvait Badkar, Group Leader- Senior Principal Scientist, Pfizer inc

3.10 Afternoon Tea

PACKAGING PFS

3.40 Key Considerations in Selection of Packaging Components andDevices for PFS system• Concern in the industry over leachables and extractables of

packaging components• Safety concerns in use of PFS• Choice of devicesSok Tiang, Regional Marketing Director, West PharmaceuticalServices

4.20 Developing sustainability in packaging Parenterals and Pre-FilledSyringes in Asia pacific• Design development phases• What are the key drivers?• Product compatibility and approaches• Pack Development and AnalysisRon Pierce, Technical Director, Cool Logistics Australia

5.00 Chairman's closing remarks

5.10 Close of day one

ly fax your registration to +65 664 990 94 or call +65 664 990 95/96

Pre-Filled Syringes Asia-Pacific Day Two | Thursday 21st July 2011-syringes.com

8.30 Re- Registration & Coffee

9.00 Chairman's Opening RemarksStefan Sundström, Technical Lead, Sterile Manufacturing, GlobalEngineering & Technology, AstraZeneca

MANUFACTURING

9.10 Opportunities in manufacturing operations: The selection process• Expectations

- Systems and Culture- Quality - Environmental Health and Safety

- Technical Capability• Negotiations• Project Management and Technical Transfer Process• Commercial Manufacturing & The Ongoing RelationshipWilliam McDaniel – Director/Team Leader, Global External Supply -Biotech Emerging Markets, Pfizer Global

9.50 Pre-fillable Syringes for the highest quality requirements - a look atmaterials, processes and services" • Materials: SCHOTT Fiolax(R) premium glass tubing • Processes: Production process resulting in a high quality product

and the subsequent monitoring in-process controls• SCHOTT TopPac(R) - the polymer alternative to glass, made of high-

quality COC. A look at special applications utilizing the specialmaterial properties.

• SCHOTT Pharma Services offers accredited lab services andexpertise based on more than 125 years of glass knowledge.

Tobias Nemeth, Product Manager Syringes, Schott

10.30 Morning Coffee

11.00 Challenges in local and external supply chains for exportingInjectables• Overcoming quality issues to deliver market need• Understanding compliance in different Asian regions• Accommodating cultural differences within Asia-PacificSunil S. Ghogre, Senior Director/Team Leader, Global External Supply,Pfizer Asia Region

11.40 Delivering QA to meet growing demands for manufacturing PreFilled Syringes in Asia Pacific• Quality assurance in manufacturing: What are the Issues• Building new sites: Meeting growing demands in local

manufacturers• Maintaining low costsStefan Sundström, Technical Lead, Sterile Manufacturing, GlobalEngineering & Technology, AstraZeneca

12.20 Networking Lunch

REGULATORY TRENDS

1.50 Regulatory Considerations in Japan• Design modifications for pen injectors in the Japanese market• Japanese specific customer requirement• Visual inspection for the Japanese marketTakao Ishida, Quality Assurance / CMC, Biogen Idec Japan Ltd

2.30 Regulatory Considerations in PFS Asia Pacific • How to define a product • How to register these products ready for development • How far can product development go? • Defining differences in regional legislations Moin Moinuddin, Asst. General Manager - Drugs Regulatory Affairs,Head QA-Preclinical and Clinical, Venus Remedies Limited

3.10 Afternoon Tea

RESEARCH

3.50 Formulation development of nanoparticle using spray dryingtechnique• Cellular uptake studies: Effect of different sugar based polymeric

redispersible spray dried nanoparticles encapsulating COX-2inhibitor as an antiangiogenic drug in breast cancer (MCF-7) cell line

Aftab Alam, Research Scholar, Faculty of Pharmacy, Jamia Hamdard New-Delhi

4.30 Using PFS for developing innovative researchIncorporating PFS in oncology discovery• Innovative local research • Point of Care diagnostic device utilising pre-filled syringes in the

designProfessor Mahesh Choolani, Senior Consultant and AssociateProfessor Obstetrics & Gynaecology, Singapore’s National UniversityHospital’s

5.10 Chairman’s Closing Remarks and Close of Conference

Who must attend?Chief Executives, Chief Scientific Officers, Vice Presidents, Heads,Directors, Principal Scientists and Managers in the following areas:

• Business Development • Chemistry, Manufacturing, Controls (CMC) • Commercial Operations • Contract Management and Partnering • Customer & Technical Support • Drug Delivery Systems • Drug Device Process Development • Drug Device Safety • Drug Product Process Development • Formulation & Aseptic Filling Technologies

• Industrial Development • Labelling • Manufacturing • Novel Drug Delivery Systems • Packaging Development • Parenterals • Pharmaceutical Sciences • Product/Pharmaceutical

Design & Development • Quality Assurance

In association with West Pharmaceutical Services Singapore

Overview of WorkshopThe packaging components that come in direct contactwith the drug in the PFS is of paramount importance. Thisis because it may interact with the pharmaceuticalpreparation be it the drug or excipients.

The fitness of the components with the barrel would alsoaffect the sterility and integrity of the final system.

In selecting the packaging components, the suitability offormulation to ensure its compatibility with the drug mustbe evaluated.

Consideration over the processing of the components, inensuring its cleanliness must also be made. For apharmaceutical manufacturer, the cost considerationmust be taken in selecting off the shelf components thathave been washed and processed to make your uniquerequirements. For those where the drug is expensivewhere rejections due to a defective component isunacceptable, development of a mutually agreeablespecification must be considered. This workshop dealswith the subjects from the perspective of a pharmaceuticalmanufacturer.

Agenda1.30 Registration

2.00 Welcome and Introductions

2.10 Perspective of a pharmaceutical manufacturer:selecting the packaging components

2.50 Processing of the components

3.30 Afternoon Coffee

3.50 Cost Considerations

4.30 Discussion and Questions

5.00 Chairman’s Closing Remarks and Close ofWorkshop

For more information and updates visit the conference websiteat asia.pre-filled-syringes.com

About the Workshop Host:Sok Tiang, Regional Marketing Director of WestPharmaceutical Services, Singapore joined the companyas its Manager, Marketing and Technical Services for AsiaPacific. Over the years, she has progressed to assumeroles of increasing responsibility. Through her regular andclose contact with the customers, she is able to to identifyand support them in addressing their critical packagingand drug delivery systems’ issues. She also serves as animportant voice to West’s corporate management team onbehalf of the customers, achieving program support forthe Singapore facility. Her ability to comprehend thecustomer and market needs is also a result of theexperience and expertise acquired whilst working in GSKin the aseptic manufacturing of injectables.

Sok Tiang holds a Bachelor of Science in Pharmacy and aMasters of Business Administration degree from theNational University of Singapore.

HALF-DAY PRE-CONFERENCE WORKSHOPTuesday 19th July 2011

Grand Copthorne Waterfront Hotel, Singapore1.30pm – 5.00pm

Selection and Processing of Packaging Components

PHARMACEUTICALFORWARD PLANNER

April 2011 13/14 Asthma & COPD

May 2011 11/12 Generics, Supergenerics

and Patent Strategies 16/17 Clinical Trial Logistics

June 2011 01/02 Pain Therapeutics 27/28 RNAi 29/30 Nanotechnology 29/30 Pharmaceutical Portfolio & Product

Lifecycle Management 29/30 KOL Europe (Munich, Germany)

July 2011 06/07 ADMET06/07 Social Media in the Pharmaceutical Industry11/12 BioBanking 18/19 Clinical Trial Logistics Asia (Singapore)20/21 Pre-Filled Syringes Asia (Singapore)

All conferences take place in central London, UK –unless indicated otherwise in brackets

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored to complementyour company’s marketing strategy. Prime networkingopportunities exist to entertain, enhance and expandyour client base within the context of an independentdiscussion specific to your industry. Should you wish tojoin the increasing number of companies benefitingfrom sponsoring our conferences please call: AliaMalick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

SPEAKING OPPORTUNITIESIf you are interested in the possibility of speaking at thisevent then please contact the Producer, Mark Callenderon: +44 (0) 20 7827 6188 or email: mcallender@smi-online.co.uk

ABOUT THE SMi PHARMACEUTICAL TEAMSMi have been involved in the pharmaceutical industrysince 1993 and have developed a series of informative andniche events, covering the latest issues and developmentssurrounding the industry. Events bring together seniorindustry professionals and serving companies who have afocus on being at the forefront of developments in thisarea. SMi aim to generate informed and topical discussionthrough the medium of both conferences and executivebriefings. Our pharmaceutical events are research-basedand content driven with regular contact with majorindustry personnel and cover a wide range of industrysectors. For more information, please visit www.smi-online.co.uk/pharma.asp

Want to know how you can get involved? Interested in promoting your pharmaceutical services to

this market?Contact Margaret Mugema, SMi Marketing

on +44 (0) 207 827 6072, or email mmugema@smi-online.co.uk

PRE-FILLED SYRINGES ASIA PACIFICConference: Wednesday 20th and Thursday 21st July 2011, Copthorne Waterfront, Singapore Workshop: Tuesday 19th July 2011, London

4 WAYS TO REGISTERasia.pre-filled-syringes.com

If you have any further queries please call the Events Team on tel +65 66 4990 95/+65 66 4990 96 or you can email them at events@smi-online.sg

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VENUE Grand Copthorne Waterfront Hotel, 392 Havelock Road, Singapore 169663

Book your accommodation at SMi discounted rates by calling the hotel directly ontel: +65 67330880, Fax: +65 67378880 email: enquiry@grandcopthorne.com.sgand make sure to refer to your attendance at this conference.

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