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 AstraZenecaSMis Pre-Filled Syringes AsiaPacific conference provides a Dr. Ghulam Moinuddin Asst. General Manager - Drugs Regulatory Affairs, Head QA-Preclinicalfundamental analysis of the key and Clinical Venus Remedies Limitedgrowth drivers in the Asia-Pacificmarket. Bringing together the KEY BENEFITS OF ATTENDINGindustrys leading figures, this • Discover the commercial opportunities in the emerging PFS Asian marketevent focuses on the opportunities • Understand the current market considerations in selection of packaging componentsand barriers when creating • Meet the growing demand for PFS in local manufacturingsuccessful strategies in this • Get to grips with regulatory trends and experiencesemerging 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 - 5.00pmasia.pre-filled-syringes.comRegister 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 orcall +65 664 990 95/96 or +44 (0) 870 9090 711
Pre-Filled Syringes Asia-PacificDay One | Wednesday 20th July 2011 asia.pre-filled 8.30 Registration & Coffee 12.20 Networking lunch 9.00 Chairmans Opening Remarks Dipankar Kaul, Auditor (GMP) for APIs, 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 Chairmans 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 Chairmans 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 Conferencely 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 2011Grand 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.
PHARMACEUTICALFORWARD PLANNERApril 201113/14 Asthma & COPDMay 201111/12 Generics, Supergenerics and Patent Strategies16/17 Clinical Trial LogisticsJune 201101/02 Pain Therapeutics27/28 RNAi29/30 Nanotechnology29/30 Pharmaceutical Portfolio & Product Lifecycle Management29/30 KOL Europe (Munich, Germany)July 201106/07 ADMET06/07 Social Media in the Pharmaceutical Industry11/12 BioBanking18/19 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 firstname.lastname@example.org
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: email@example.com 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$4599Unique Reference Number □ Conference only S$3099 S$3316Our Reference LVY11 □ Full-Day Workshop only S$1199 S$1283 PROMOTIONAL LITERATURE DISTRIBUTIONDELEGATE DETAILS □ Distribution of your company’s promotionalPlease complete fully and clearly in capital letters. Please photocopy for additional delegates. literature to all conference attendees S$1999 S$2139Title: Forename: GROUP DISCOUNTS AVAILABLESurname: The Conference fee includes refreshments, lunch, conference papers andJob Title: CD ROM containing all of the presentations.Department/Division:Company/Organisation: VENUE Grand Copthorne Waterfront Hotel, 392 Havelock Road, Singapore 169663Email: Book your accommodation at SMi discounted rates by calling the hotel directly onAddress: tel: +65 67330880, Fax: +65 67378880 email: firstname.lastname@example.org and make sure to refer to your attendance at this conference.Town/City:Post/Zip Code: Country: CD ROMS/DOCUMENTATIONDirect Tel: Direct Fax: I cannot attend but would like to purchase the following CD ROMs/paper copyMobile: documentation: (Shipped 10-14 days after the event) Price □ The Conference Presentations on CD ROM S$999 +VAT S$1069Switchboard: □ The Conference Presentations - paper copy S$999 +VAT S$1069Signature: Date: (or only S$600 if ordered with a CD ROM)I agree to be bound by SMis Terms and Conditions of Booking.ACCOUNTS DEPT PAYMENT DUE WITH ORDERTitle: 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 cardTerms 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 SMis Terms and Conditions of Booking.delegates may not ‘share’ a place at an event. Please make separate bookings for eachdelegate. Card Billing Address (If different from above):Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, 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 startof the event. Regretfully cancellation after this time cannot be accepted. We will howeverprovide the Conference documentation on CD ROM to any delegate who has paid but isunable to attend for any reason. Due to the interactive nature of the Briefings we are notnormally able to provide documentation in these circumstances. We cannot acceptcancellations of orders placed for Documentation or CD ROM as these are reproducedspecifically to order. If we have to cancel the event for any reason, then we will make a fullrefund 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 DataProtection 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 yourdata with third parties offering complementary products or services. If you have any queriesor 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.email@example.com or visit our website www.smi-online.co.uk/updatesquoting 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 firstname.lastname@example.org