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


                              SMi present their annual conference on...

  Pre-Filled Syringes Asia Pacific
                  Expanding Strategies for the Emerging Market
                               Wednesday 20th & Thursday 21st July 2011
                              Grand Copthorne Waterfront Hotel, Singapore

                                             KEY SPEAKERS INCLUDE:
                                                      Dr Vinod Vilivalam
                                                      Director of Strategic Market and Technical Development
                                                      West Pharmaceutical Services

                                                      Takao Ishida
                                                      Quality Assurance / CMC
                                                      Biogen Idec Japan Ltd

                                                      Dipankar Kaul
                                                      Auditor (GMP) for API’s, Formulations and Medical Devices
                                                      Sanofi-Aventis

                                                      William McDaniel
                                                      Director/Team Leader, Global External Supply - Biotech Emerging
                                                      Markets
                                                      Pfizer Global

                                                      Sunil S. Ghogre
                                                      Senior Director/Team Leader, Global External Supply
                                                      Pfizer Asia Region

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

                                                      Stefan Sundström
                                                      Technical Lead, Sterile Manufacturing, Global Engineering & Technology
                                                      AstraZeneca
SMi's Pre-Filled Syringes Asia
Pacific conference provides a                         Dr. Ghulam Moinuddin
                                                      Asst. General Manager - Drugs Regulatory Affairs, Head QA-Preclinical
fundamental analysis of the key                       and Clinical
                                                      Venus Remedies Limited
growth drivers in the Asia-Pacific
market. Bringing together the
                                             KEY BENEFITS OF ATTENDING
industry's leading figures, this
                                             • Discover the commercial opportunities in the emerging PFS Asian market
event focuses on the opportunities           • Understand the current market considerations in selection of packaging components
and barriers when creating                   • Meet the growing demand for PFS in local manufacturing
successful strategies in this                • Get to grips with regulatory trends and experiences
emerging market.                             • Combat contamination risks with sterile manufacturing


               Sponsored by                      PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP
                                             Tuesday 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 conferences
Alternatively 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
Pre-Filled Syringes Asia-Pacific
Day One | Wednesday 20th July 2011                                                                                                                    asia.pre-filled
 8.30     Registration & Coffee                                                              12.20    Networking lunch
 9.00     Chairman's Opening Remarks
          Dipankar Kaul, Auditor (GMP) for API's, Formulations and Medical                   1.50     Challenges in ensuring quality and patient safety in PFS
          Devices, Sanofi-Aventis                                                                     • Reducing contamination risks in multi-viral doses
                                                                                                      • Quality assurances: What can we learn from Europe and the US
                           ASIAN MARKET OVERVIEW
                                                                                                      • Analysing risks in pre-filling for devices
 9.10     COMMERICAL OPPORTUNITEIS IN THE PRE FILLED SYRINGES AND                                     • Safety issues: Preparation of drugs at the bedside vs. prefilled
          DEVICES ASIAN MARKET                                                                          syringes
          • Growth drivers in the parenteral and pre-filled syringes market
          • Developing future strategies for parenterals and PFS                                      Michael Crockett, Principle, Crockett Biotech Consulting
          • Utilising the commercial opportunities in PFS drug delivery
          A.P. Raja, Business Head – Emerging Markets (International
          Operations), AXA Parenterals                                                                                          BIOTECHNOLOGY

 9.50     Production processes and machinery: Trends and overview                            2.30     Biotechnology and Pre-Filled Syringes
          in Asia Pacific
          • Trends in processing pre-filled syringes                                                  • Biologics Manufacturing
          • In process weighing control for prefilled syringes - what is available                    • Process Engineering
            on the market                                                                             • Transfer manufacturing process between clinical and commercial
          • Transition to vials: the true cost of production
          • New developments - syringe filling machines                                                 facilities
          Dale Charlton, Director of Business Development, Optima Group                               Advait Badkar, Group Leader- Senior Principal Scientist, Pfizer inc
          Pharma
 10.30    Morning Coffee                                                                     3.10     Afternoon Tea

                              NEW DEVELOPMENTS
                                                                                                                                PACKAGING PFS
 11.00    Recent Trends in Plastic Prefillable Syringe and Vial Systems for
          Biopharmaceutical Drug Delivery                                                    3.40     Key Considerations in Selection of Packaging Components and
          Cyclic olefin polymers and Flurotec elastomers
          • Recent trends in the use of newer plastics for delivering mAbs,                           Devices for PFS system
            proteins and vaccines.                                                                    • Concern in the industry over leachables and extractables of
          • Solve challenges associated with glass prefilled syringes, including                        packaging components
            breakage and the reactivity and leachables like silicone, tungsten
            and glue.                                                                                 • Safety concerns in use of PFS
          • Market and scientific needs for plastic prefillable syringes for                          • Choice of devices
            biopharmaceutical drugs and high viscosity formulations.                                  Sok Tiang, Regional Marketing Director, West Pharmaceutical
          • Plastic vials for break resistant, less reactive and cold temperature
            storage/transport containers for biologics and stem cells.                                Services
          Vinod D. Vilivalem, Director of Strategic Market and Technical
          Development, West Pharmaceutical Services                                          4.20     Developing sustainability in packaging Parenterals and Pre-Filled
                                QUALITY CONTROL                                                       Syringes in Asia pacific
                                                                                                      • Design development phases
 11.40    Assuring Safety & Quality of Pre-filled syringes
          Implementing Pharma Quality Management                                                      • What are the key drivers?
          • Material, design and construction of pre-filled syringes.                                 • Product compatibility and approaches
          • Manufacturing & filling process : Influences and Needs for Glass                          • Pack Development and Analysis
            and Polymer based pre-filled syringes
          • Primary container compatibility, extractable and leachable studies                        Ron Pierce, Technical Director, Cool Logistics Australia
          • Interaction between the primary container system and the injection
            device                                                                           5.00     Chairman's closing remarks
          • Structuring the Quality System
          Dipankar Kaul, Auditor (GMP) for API’s, Formulations and Medical
          Devices, Sanofi-Aventis                                                            5.10     Close of day one



                                            Register online at asia.pre-filled-syringes.com • Alternativel
             Sponsored by
                                                The OPTIMA GROUP pharma with the long established brands of inova, Kugler and Klee, offer a comprehensive, cutting-edge range
                                                of products and services. This includes the filling and packaging of pharmaceutical liquids and powders, as well as up and
                                                downstream processing, freeze dryers and automatic loading systems. Combined production and packaging lines for
                                                medical/pharmaceutical products as well as automation and laboratory processes are also part of the portfolio. The OPTIMA GROUP
                                                pharma 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-filled
                                                cartridges. Designed to meet the individual needs of our partners & those of varying user groups, these systems facilitate ease of use
                                                and 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 of
                                                services in its role as a system supplier. R+E is focussed mainly on the pharmaceutical market with its special requirements and has
                                                more than 20 years experience in needle bonding machines for prefilled syringes with stacked needles. www.re-automation.de



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

    8.30    Re- Registration & Coffee                                                    12.20   Networking Lunch

    9.00    Chairman's Opening Remarks
                                                                                                                    REGULATORY TRENDS
            Stefan Sundström, Technical Lead, Sterile Manufacturing, Global
            Engineering & Technology, AstraZeneca
                                                                                         1.50    Regulatory Considerations in Japan
                                 MANUFACTURING                                                   • Design modifications for pen injectors in the Japanese market
                                                                                                 • Japanese specific customer requirement
    9.10    Opportunities in manufacturing operations: The selection process
            • Expectations                                                                       • Visual inspection for the Japanese market
              - Systems and Culture                                                              Takao Ishida, Quality Assurance / CMC, Biogen Idec Japan Ltd
                - Quality
                - Environmental Health and Safety
              - Technical Capability                                                     2.30    Regulatory Considerations in PFS Asia Pacific
            • Negotiations                                                                       • How to define a product
            • Project Management and Technical Transfer Process                                  • How to register these products ready for development
            • Commercial Manufacturing & The Ongoing Relationship                                • How far can product development go?
            William McDaniel – Director/Team Leader, Global External Supply -
            Biotech Emerging Markets, Pfizer Global                                              • Defining differences in regional legislations
                                                                                                 Moin Moinuddin, Asst. General Manager - Drugs Regulatory Affairs,
    9.50    Pre-fillable Syringes for the highest quality requirements - a look at               Head QA-Preclinical and Clinical, Venus Remedies Limited
            materials, processes and services"
            • Materials: SCHOTT Fiolax(R) premium glass tubing
            • Processes: Production process resulting in a high quality product          3.10    Afternoon Tea
              and the subsequent monitoring in-process controls
            • SCHOTT TopPac(R) - the polymer alternative to glass, made of high-                                          RESEARCH
              quality COC. A look at special applications utilizing the special
              material properties.
            • SCHOTT Pharma Services offers accredited lab services and                  3.50    Formulation development of nanoparticle using spray drying
              expertise based on more than 125 years of glass knowledge.                         technique
            Tobias Nemeth, Product Manager Syringes, Schott                                      • Cellular uptake studies: Effect of different sugar based polymeric
                                                                                                   redispersible spray dried nanoparticles encapsulating COX-2
    10.30   Morning Coffee
                                                                                                   inhibitor as an antiangiogenic drug in breast cancer (MCF-7) cell line
    11.00   Challenges in local and external supply chains for exporting                         Aftab Alam, Research Scholar, Faculty of Pharmacy, Jamia Hamdard
            Injectables                                                                          New-Delhi
            • Overcoming quality issues to deliver market need
            • Understanding compliance in different Asian regions
            • Accommodating cultural differences within Asia-Pacific                     4.30    Using PFS for developing innovative research
            Sunil S. Ghogre, Senior Director/Team Leader, Global External Supply,                Incorporating PFS in oncology discovery
            Pfizer Asia Region                                                                   • Innovative local research
                                                                                                 • Point of Care diagnostic device utilising pre-filled syringes in the
    11.40   Delivering QA to meet growing demands for manufacturing Pre
            Filled Syringes in Asia Pacific                                                        design
            • Quality assurance in manufacturing: What are the Issues                            Professor Mahesh Choolani, Senior Consultant and Associate
            • Building new sites: Meeting growing demands in local                               Professor Obstetrics & Gynaecology, Singapore’s National University
              manufacturers
                                                                                                 Hospital’s
            • Maintaining low costs
            Stefan Sundström, Technical Lead, Sterile Manufacturing, Global
            Engineering & Technology, AstraZeneca                                        5.10    Chairman’s Closing Remarks and Close of Conference



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

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

                                                                                     • Business Development                             • Industrial Development
                                                                                     • Chemistry, Manufacturing, Controls (CMC)         • Labelling
                                                                                     • Commercial Operations                            • Manufacturing
                                                                                     • Contract Management and Partnering               • Novel Drug Delivery Systems
                                                                                     • Customer & Technical Support                     • Packaging Development
                                                                                     • Drug Delivery Systems                            • Parenterals
                                                                                     • Drug Device Process Development                  • Pharmaceutical Sciences
                                                                                     • Drug Device Safety                               • Product/Pharmaceutical
                                                                                     • Drug Product Process Development                   Design & Development
                                                                                     • Formulation & Aseptic Filling Technologies       • Quality Assurance
HALF-DAY PRE-CONFERENCE WORKSHOP
          Tuesday 19th July 2011
Grand Copthorne Waterfront Hotel, Singapore
                     1.30pm – 5.00pm

        Selection and Processing
        of Packaging Components

    In association with West Pharmaceutical Services Singapore



 Overview of Workshop
 The packaging components that come in direct contact
 with the drug in the PFS is of paramount importance. This
 is because it may interact with the pharmaceutical
 preparation be it the drug or excipients.

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

 In selecting the packaging components, the suitability of
 formulation to ensure its compatibility with the drug must
 be evaluated.

 Consideration over the processing of the components, in
 ensuring its cleanliness must also be made. For a
 pharmaceutical manufacturer, the cost consideration
 must be taken in selecting off the shelf components that
 have been washed and processed to make your unique
 requirements. For those where the drug is expensive
 where rejections due to a defective component is
 unacceptable, development of a mutually agreeable
 specification must be considered. This workshop deals
 with the subjects from the perspective of a pharmaceutical
 manufacturer.


 Agenda
 1.30   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 of
          Workshop

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


 About the Workshop Host:
 Sok Tiang, Regional Marketing Director of West
 Pharmaceutical Services, Singapore joined the company
 as its Manager, Marketing and Technical Services for Asia
 Pacific. Over the years, she has progressed to assume
 roles of increasing responsibility. Through her regular and
 close contact with the customers, she is able to to identify
 and support them in addressing their critical packaging
 and drug delivery systems’ issues. She also serves as an
 important voice to West’s corporate management team on
 behalf of the customers, achieving program support for
 the Singapore facility. Her ability to comprehend the
 customer and market needs is also a result of the
 experience and expertise acquired whilst working in GSK
 in the aseptic manufacturing of injectables.

 Sok Tiang holds a Bachelor of Science in Pharmacy and a
 Masters of Business Administration degree from the
 National University of Singapore.
PHARMACEUTICAL
FORWARD 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   ADMET
06/07   Social Media in the Pharmaceutical Industry
11/12   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 OPPORTUNITIES
 SMi offer sponsorship, exhibition, advertising and
 branding packages, uniquely tailored to complement
 your company’s marketing strategy. Prime networking
 opportunities exist to entertain, enhance and expand
 your client base within the context of an independent
 discussion specific to your industry. Should you wish to
 join the increasing number of companies benefiting
 from sponsoring our conferences please call: Alia
 Malick on +44 (0) 20 7827 6168 or email: amalick@smi-
 online.co.uk



 SPEAKING OPPORTUNITIES
 If you are interested in the possibility of speaking at this
 event then please contact the Producer, Mark Callender
 on: +44 (0) 20 7827 6188 or email: mcallender@smi-
 online.co.uk



 ABOUT THE SMi PHARMACEUTICAL TEAM
 SMi have been involved in the pharmaceutical industry
 since 1993 and have developed a series of informative and
 niche events, covering the latest issues and developments
 surrounding the industry. Events bring together senior
 industry professionals and serving companies who have a
 focus on being at the forefront of developments in this
 area. SMi aim to generate informed and topical discussion
 through the medium of both conferences and executive
 briefings. Our pharmaceutical events are research-based
 and content driven with regular contact with major
 industry personnel and cover a wide range of industry
 sectors. 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 PACIFIC
                Conference: Wednesday 20th and Thursday 21st July 2011, Copthorne Waterfront, Singapore                                            Workshop: Tuesday 19th July 2011, London

                                                                                               4 WAYS TO REGISTER
                                                                                             asia.pre-filled-syringes.com
                                                                                     +65 664 990 95/96 or +44 (0) 870 9090 711
                      Email: events@smi-online.sg                                     FAX your booking form to +65 664 990 94 or +44 (0) 870 9090 712

                                                                                                         EARLY BIRD □ Book by March 31st to receive S$300 off conference price
                                                                                                          DISCOUNT □ Book by April 28th to receive S$100 off conference price

                                                                                                         CONFERENCE PRICES
                                                                                                        I would like to attend:                                         NON SINGAPORE   SINGAPORE CLIENTS
                                                                                                        (Please tick as appropriate)                                       CLIENTS         INCLUDING VAT

                                                                                                        □ Conference & Full-Day Workshop                                   S$4298             S$4599
Unique Reference Number                                                                                 □ Conference only                                                  S$3099             S$3316
Our Reference                                     LVY11                                                 □ Full-Day Workshop only                                           S$1199             S$1283

                                                                                                        PROMOTIONAL LITERATURE DISTRIBUTION
DELEGATE DETAILS                                                                                        □ Distribution of your company’s promotional
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.          literature to all conference attendees                           S$1999             S$2139
Title:                     Forename:                                                                                                      GROUP DISCOUNTS AVAILABLE
Surname:                                                                                                The Conference fee includes refreshments, lunch, conference papers and
Job Title:                                                                                              CD ROM containing all of the presentations.
Department/Division:
Company/Organisation:
                                                                                                         VENUE            Grand Copthorne Waterfront Hotel, 392 Havelock Road, Singapore 169663
Email:
                                                                                                        Book your accommodation at SMi discounted rates by calling the hotel directly on
Address:                                                                                                tel: +65 67330880, Fax: +65 67378880 email: enquiry@grandcopthorne.com.sg
                                                                                                        and make sure to refer to your attendance at this conference.
Town/City:
Post/Zip Code:                                      Country:                                             CD ROMS/DOCUMENTATION
Direct Tel:                                          Direct Fax:                                        I cannot attend but would like to purchase the following CD ROMs/paper copy
Mobile:
                                                                                                        documentation: (Shipped 10-14 days after the event)  Price
                                                                                                        □ The Conference Presentations on CD ROM             S$999     +VAT S$1069
Switchboard:
                                                                                                        □ The Conference Presentations - paper copy          S$999     +VAT S$1069
Signature:                                                             Date:                                (or only S$600 if ordered with a CD ROM)
I agree to be bound by SMi's Terms and Conditions of Booking.

ACCOUNTS DEPT
                                                                                                         PAYMENT DUE WITH ORDER
Title:                     Forename:
                                                                                                        CARD PAYMENT ONLY - TO BE RECEIVED WITH THE ORDER.
Surname:                                                                                                An invoice will be supplied for your records on receipt of the order/payment.
Email:                                                                                                  Please fill in your credit card details below:

Address (if different from above):                                                                      □ Visa             □ MasterCard                □ American Express
                                                                                                        All credit card payments will be subject to standard credit card charges.

Town/City:                                                                                              Card No:  □□□□ □□□□ □□□□ □□□□
Post/Zip Code:                                      Country:                                            Valid From □□/□□ Expiry Date □□/□□
Direct Tel:                                          Direct Fax:                                        CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card

Terms and Conditions of Booking                                                                         Cardholder’s Name:

Payment: Payments must be made with the order.
                                                                                                        Signature:                                                          Date:
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing,
another delegate to take your place at any time prior to the start of the event. Two or more            I agree to be bound by SMi's Terms and Conditions of Booking.
delegates may not ‘share’ a place at an event. Please make separate bookings for each
delegate.
                                                                                                        Card Billing Address (If different from above):
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a S$100 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start
of the event. Regretfully cancellation after this time cannot be accepted. We will however
provide the Conference documentation on CD ROM to any delegate who has paid but is
unable to attend for any reason. Due to the interactive nature of the Briefings we are not
normally able to provide documentation in these circumstances. We cannot accept
cancellations of orders placed for Documentation or CD ROM as these are reproduced
specifically to order. If we have to cancel the event for any reason, then we will make a full
refund immediately, but disclaim any further liability.

Alterations: It may become necessary for us to make alterations to the content, speakers,
timing, venue or date of the event compared to the advertised programme.

Data Protection: The SMi Group gathers personal data in accordance with the UK Data
Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to               VAT
                                                                            □
tell you about other products and services. Unless you tick here we may also share your
data with third parties offering complementary products or services. If you have any queries
or want to update any of the data that we hold then please contact our Database Manager                 Clients from Singapore will need to pay 7% VAT, those outside of Singapore will not need to pay VAT.
databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates
quoting the URN as detailed above your address on the attached letter.

    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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Pre Filled Syringes Asia Pacific

  • 1. Register by March 31st and receive a $300 discount Register by April 28th and receive a $100 discount SMi present their annual conference on... Pre-Filled Syringes Asia Pacific Expanding Strategies for the Emerging Market Wednesday 20th & Thursday 21st July 2011 Grand Copthorne Waterfront Hotel, Singapore KEY SPEAKERS INCLUDE: Dr Vinod Vilivalam Director of Strategic Market and Technical Development West Pharmaceutical Services Takao Ishida Quality Assurance / CMC Biogen Idec Japan Ltd Dipankar Kaul Auditor (GMP) for API’s, Formulations and Medical Devices Sanofi-Aventis William McDaniel Director/Team Leader, Global External Supply - Biotech Emerging Markets Pfizer Global Sunil S. Ghogre Senior Director/Team Leader, Global External Supply Pfizer Asia Region A.P. Raja Business Head – Emerging Markets (International Operations) AXA Parenterals Stefan Sundström Technical Lead, Sterile Manufacturing, Global Engineering & Technology AstraZeneca SMi's Pre-Filled Syringes Asia Pacific conference provides a Dr. Ghulam Moinuddin Asst. General Manager - Drugs Regulatory Affairs, Head QA-Preclinical fundamental analysis of the key and Clinical Venus Remedies Limited growth drivers in the Asia-Pacific market. Bringing together the KEY BENEFITS OF ATTENDING industry's leading figures, this • Discover the commercial opportunities in the emerging PFS Asian market event focuses on the opportunities • Understand the current market considerations in selection of packaging components and barriers when creating • Meet the growing demand for PFS in local manufacturing successful strategies in this • Get to grips with regulatory trends and experiences emerging market. • Combat contamination risks with sterile manufacturing Sponsored by PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP Tuesday 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 conferences Alternatively 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
  • 2. Pre-Filled Syringes Asia-Pacific Day One | Wednesday 20th July 2011 asia.pre-filled 8.30 Registration & Coffee 12.20 Networking lunch 9.00 Chairman's Opening Remarks Dipankar Kaul, Auditor (GMP) for API's, Formulations and Medical 1.50 Challenges in ensuring quality and patient safety in PFS Devices, Sanofi-Aventis • Reducing contamination risks in multi-viral doses • Quality assurances: What can we learn from Europe and the US ASIAN MARKET OVERVIEW • Analysing risks in pre-filling for devices 9.10 COMMERICAL OPPORTUNITEIS IN THE PRE FILLED SYRINGES AND • Safety issues: Preparation of drugs at the bedside vs. prefilled DEVICES ASIAN MARKET syringes • Growth drivers in the parenteral and pre-filled syringes market • Developing future strategies for parenterals and PFS Michael Crockett, Principle, Crockett Biotech Consulting • Utilising the commercial opportunities in PFS drug delivery A.P. Raja, Business Head – Emerging Markets (International Operations), AXA Parenterals BIOTECHNOLOGY 9.50 Production processes and machinery: Trends and overview 2.30 Biotechnology and Pre-Filled Syringes in Asia Pacific • Trends in processing pre-filled syringes • Biologics Manufacturing • In process weighing control for prefilled syringes - what is available • Process Engineering on the market • Transfer manufacturing process between clinical and commercial • Transition to vials: the true cost of production • New developments - syringe filling machines facilities Dale Charlton, Director of Business Development, Optima Group Advait Badkar, Group Leader- Senior Principal Scientist, Pfizer inc Pharma 10.30 Morning Coffee 3.10 Afternoon Tea NEW DEVELOPMENTS PACKAGING PFS 11.00 Recent Trends in Plastic Prefillable Syringe and Vial Systems for Biopharmaceutical Drug Delivery 3.40 Key Considerations in Selection of Packaging Components and Cyclic olefin polymers and Flurotec elastomers • Recent trends in the use of newer plastics for delivering mAbs, Devices for PFS system proteins and vaccines. • Concern in the industry over leachables and extractables of • Solve challenges associated with glass prefilled syringes, including packaging components breakage and the reactivity and leachables like silicone, tungsten and glue. • Safety concerns in use of PFS • Market and scientific needs for plastic prefillable syringes for • Choice of devices biopharmaceutical drugs and high viscosity formulations. Sok Tiang, Regional Marketing Director, West Pharmaceutical • Plastic vials for break resistant, less reactive and cold temperature storage/transport containers for biologics and stem cells. Services Vinod D. Vilivalem, Director of Strategic Market and Technical Development, West Pharmaceutical Services 4.20 Developing sustainability in packaging Parenterals and Pre-Filled QUALITY CONTROL Syringes in Asia pacific • Design development phases 11.40 Assuring Safety & Quality of Pre-filled syringes Implementing Pharma Quality Management • What are the key drivers? • Material, design and construction of pre-filled syringes. • Product compatibility and approaches • Manufacturing & filling process : Influences and Needs for Glass • Pack Development and Analysis and Polymer based pre-filled syringes • Primary container compatibility, extractable and leachable studies Ron Pierce, Technical Director, Cool Logistics Australia • Interaction between the primary container system and the injection device 5.00 Chairman's closing remarks • Structuring the Quality System Dipankar Kaul, Auditor (GMP) for API’s, Formulations and Medical Devices, Sanofi-Aventis 5.10 Close of day one Register online at asia.pre-filled-syringes.com • Alternativel Sponsored by The OPTIMA GROUP pharma with the long established brands of inova, Kugler and Klee, offer a comprehensive, cutting-edge range of products and services. This includes the filling and packaging of pharmaceutical liquids and powders, as well as up and downstream processing, freeze dryers and automatic loading systems. Combined production and packaging lines for medical/pharmaceutical products as well as automation and laboratory processes are also part of the portfolio. The OPTIMA GROUP pharma 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-filled cartridges. Designed to meet the individual needs of our partners & those of varying user groups, these systems facilitate ease of use and 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 of services in its role as a system supplier. R+E is focussed mainly on the pharmaceutical market with its special requirements and has more than 20 years experience in needle bonding machines for prefilled syringes with stacked needles. www.re-automation.de Supported by
  • 3. Pre-Filled Syringes Asia-Pacific -syringes.com Day Two | Thursday 21st July 2011 8.30 Re- Registration & Coffee 12.20 Networking Lunch 9.00 Chairman's Opening Remarks REGULATORY TRENDS Stefan Sundström, Technical Lead, Sterile Manufacturing, Global Engineering & Technology, AstraZeneca 1.50 Regulatory Considerations in Japan MANUFACTURING • Design modifications for pen injectors in the Japanese market • Japanese specific customer requirement 9.10 Opportunities in manufacturing operations: The selection process • Expectations • Visual inspection for the Japanese market - Systems and Culture Takao Ishida, Quality Assurance / CMC, Biogen Idec Japan Ltd - Quality - Environmental Health and Safety - Technical Capability 2.30 Regulatory Considerations in PFS Asia Pacific • Negotiations • How to define a product • Project Management and Technical Transfer Process • How to register these products ready for development • Commercial Manufacturing & The Ongoing Relationship • How far can product development go? William McDaniel – Director/Team Leader, Global External Supply - Biotech Emerging Markets, Pfizer Global • Defining differences in regional legislations Moin Moinuddin, Asst. General Manager - Drugs Regulatory Affairs, 9.50 Pre-fillable Syringes for the highest quality requirements - a look at Head QA-Preclinical and Clinical, Venus Remedies Limited materials, processes and services" • Materials: SCHOTT Fiolax(R) premium glass tubing • Processes: Production process resulting in a high quality product 3.10 Afternoon Tea and the subsequent monitoring in-process controls • SCHOTT TopPac(R) - the polymer alternative to glass, made of high- RESEARCH quality COC. A look at special applications utilizing the special material properties. • SCHOTT Pharma Services offers accredited lab services and 3.50 Formulation development of nanoparticle using spray drying expertise based on more than 125 years of glass knowledge. technique Tobias Nemeth, Product Manager Syringes, Schott • Cellular uptake studies: Effect of different sugar based polymeric redispersible spray dried nanoparticles encapsulating COX-2 10.30 Morning Coffee inhibitor as an antiangiogenic drug in breast cancer (MCF-7) cell line 11.00 Challenges in local and external supply chains for exporting Aftab Alam, Research Scholar, Faculty of Pharmacy, Jamia Hamdard Injectables New-Delhi • Overcoming quality issues to deliver market need • Understanding compliance in different Asian regions • Accommodating cultural differences within Asia-Pacific 4.30 Using PFS for developing innovative research Sunil S. Ghogre, Senior Director/Team Leader, Global External Supply, Incorporating PFS in oncology discovery Pfizer Asia Region • Innovative local research • Point of Care diagnostic device utilising pre-filled syringes in the 11.40 Delivering QA to meet growing demands for manufacturing Pre Filled Syringes in Asia Pacific design • Quality assurance in manufacturing: What are the Issues Professor Mahesh Choolani, Senior Consultant and Associate • Building new sites: Meeting growing demands in local Professor Obstetrics & Gynaecology, Singapore’s National University manufacturers Hospital’s • Maintaining low costs Stefan Sundström, Technical Lead, Sterile Manufacturing, Global Engineering & Technology, AstraZeneca 5.10 Chairman’s Closing Remarks and Close of Conference ly fax your registration to +65 664 990 94 or call +65 664 990 95/96 Who must attend? Chief Executives, Chief Scientific Officers, Vice Presidents, Heads, Directors, Principal Scientists and Managers in the following areas: • Business Development • Industrial Development • Chemistry, Manufacturing, Controls (CMC) • Labelling • Commercial Operations • Manufacturing • Contract Management and Partnering • Novel Drug Delivery Systems • Customer & Technical Support • Packaging Development • Drug Delivery Systems • Parenterals • Drug Device Process Development • Pharmaceutical Sciences • Drug Device Safety • Product/Pharmaceutical • Drug Product Process Development Design & Development • Formulation & Aseptic Filling Technologies • Quality Assurance
  • 4. HALF-DAY PRE-CONFERENCE WORKSHOP Tuesday 19th July 2011 Grand Copthorne Waterfront Hotel, Singapore 1.30pm – 5.00pm Selection and Processing of Packaging Components In association with West Pharmaceutical Services Singapore Overview of Workshop The packaging components that come in direct contact with the drug in the PFS is of paramount importance. This is because it may interact with the pharmaceutical preparation be it the drug or excipients. The fitness of the components with the barrel would also affect the sterility and integrity of the final system. In selecting the packaging components, the suitability of formulation to ensure its compatibility with the drug must be evaluated. Consideration over the processing of the components, in ensuring its cleanliness must also be made. For a pharmaceutical manufacturer, the cost consideration must be taken in selecting off the shelf components that have been washed and processed to make your unique requirements. For those where the drug is expensive where rejections due to a defective component is unacceptable, development of a mutually agreeable specification must be considered. This workshop deals with the subjects from the perspective of a pharmaceutical manufacturer. Agenda 1.30 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 of Workshop For more information and updates visit the conference website at asia.pre-filled-syringes.com About the Workshop Host: Sok Tiang, Regional Marketing Director of West Pharmaceutical Services, Singapore joined the company as its Manager, Marketing and Technical Services for Asia Pacific. Over the years, she has progressed to assume roles of increasing responsibility. Through her regular and close contact with the customers, she is able to to identify and support them in addressing their critical packaging and drug delivery systems’ issues. She also serves as an important voice to West’s corporate management team on behalf of the customers, achieving program support for the Singapore facility. Her ability to comprehend the customer and market needs is also a result of the experience and expertise acquired whilst working in GSK in the aseptic manufacturing of injectables. Sok Tiang holds a Bachelor of Science in Pharmacy and a Masters of Business Administration degree from the National University of Singapore.
  • 5. PHARMACEUTICAL FORWARD 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 ADMET 06/07 Social Media in the Pharmaceutical Industry 11/12 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 OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi- online.co.uk SPEAKING OPPORTUNITIES If you are interested in the possibility of speaking at this event then please contact the Producer, Mark Callender on: +44 (0) 20 7827 6188 or email: mcallender@smi- online.co.uk ABOUT THE SMi PHARMACEUTICAL TEAM SMi have been involved in the pharmaceutical industry since 1993 and have developed a series of informative and niche events, covering the latest issues and developments surrounding the industry. Events bring together senior industry professionals and serving companies who have a focus on being at the forefront of developments in this area. SMi aim to generate informed and topical discussion through the medium of both conferences and executive briefings. Our pharmaceutical events are research-based and content driven with regular contact with major industry personnel and cover a wide range of industry sectors. 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
  • 6. PRE-FILLED SYRINGES ASIA PACIFIC Conference: Wednesday 20th and Thursday 21st July 2011, Copthorne Waterfront, Singapore Workshop: Tuesday 19th July 2011, London 4 WAYS TO REGISTER asia.pre-filled-syringes.com +65 664 990 95/96 or +44 (0) 870 9090 711 Email: events@smi-online.sg FAX your booking form to +65 664 990 94 or +44 (0) 870 9090 712 EARLY BIRD □ Book by March 31st to receive S$300 off conference price DISCOUNT □ Book by April 28th to receive S$100 off conference price CONFERENCE PRICES I would like to attend: NON SINGAPORE SINGAPORE CLIENTS (Please tick as appropriate) CLIENTS INCLUDING VAT □ Conference & Full-Day Workshop S$4298 S$4599 Unique Reference Number □ Conference only S$3099 S$3316 Our Reference LVY11 □ Full-Day Workshop only S$1199 S$1283 PROMOTIONAL LITERATURE DISTRIBUTION DELEGATE DETAILS □ Distribution of your company’s promotional Please complete fully and clearly in capital letters. Please photocopy for additional delegates. literature to all conference attendees S$1999 S$2139 Title: Forename: GROUP DISCOUNTS AVAILABLE Surname: The Conference fee includes refreshments, lunch, conference papers and Job Title: CD ROM containing all of the presentations. Department/Division: Company/Organisation: VENUE Grand Copthorne Waterfront Hotel, 392 Havelock Road, Singapore 169663 Email: Book your accommodation at SMi discounted rates by calling the hotel directly on Address: tel: +65 67330880, Fax: +65 67378880 email: enquiry@grandcopthorne.com.sg and make sure to refer to your attendance at this conference. Town/City: Post/Zip Code: Country: CD ROMS/DOCUMENTATION Direct Tel: Direct Fax: I cannot attend but would like to purchase the following CD ROMs/paper copy Mobile: documentation: (Shipped 10-14 days after the event) Price □ The Conference Presentations on CD ROM S$999 +VAT S$1069 Switchboard: □ The Conference Presentations - paper copy S$999 +VAT S$1069 Signature: Date: (or only S$600 if ordered with a CD ROM) I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT PAYMENT DUE WITH ORDER Title: Forename: CARD PAYMENT ONLY - TO BE RECEIVED WITH THE ORDER. Surname: An invoice will be supplied for your records on receipt of the order/payment. Email: Please fill in your credit card details below: Address (if different from above): □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Town/City: Card No: □□□□ □□□□ □□□□ □□□□ Post/Zip Code: Country: Valid From □□/□□ Expiry Date □□/□□ Direct Tel: Direct Fax: CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Terms and Conditions of Booking Cardholder’s Name: Payment: Payments must be made with the order. Signature: Date: Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more I agree to be bound by SMi's Terms and Conditions of Booking. delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Card Billing Address (If different from above): Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a S$100 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the Conference documentation on CD ROM to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or CD ROM as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to VAT □ tell you about other products and services. Unless you tick here we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager Clients from Singapore will need to pay 7% VAT, those outside of Singapore will not need to pay VAT. databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. 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