SMi's Pre-Filled Syringes Asia Pacific conference provides a fundamental analysis of the key growth drivers in the Asia-Pacific pre-filled syringes market. The conference brings together industry leaders to focus on opportunities and barriers to creating successful strategies in this emerging market. Register by March 31st to receive a $300 discount, or by April 28th to receive a $100 discount. The conference will take place on July 20-21, 2011 in Singapore and will include presentations and discussions on topics such as commercial opportunities, manufacturing, packaging, quality control, and regulatory trends related to pre-filled syringes in 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
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