Floor0BS, UK
4, London
WHY ATTEND THIS EVENT:• 3 days of presentations, panel discussions and interactive
workshops. Return to your business with the information andcontacts to make the right decisions for your products
• Focus sessions on biologics, manufacturing, polymers andextractables and leachables
• 20+ expert speakers from throughout the PFS and device ecosystem• 85+ key decision makers, influencers and innovation drivers
attending from the most relevant and sought after organisations inpre-filled syringes
• Network with delegates from the leading Biotechnology andPharmaceutical businesses globally during the series of networkingbreaks, lunches and networking evenings designed to helpconversation flow
• Hands on exhibition to help you evaluate the leading solutions in themarketplace and meet the thought leaders who developed them
SMi present the 8th conference and exhibition in its world leading series...
PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPWednesday 2nd April 2014, Iselin, New Jersey, USA
Accelerating the regulatory approval of your pre-filled product: Insight into combination product approvals
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA Senior Executive, and Mr. Sall, Principal Consultant, ParExel8.30am - 12.30pm
31ST MARCH
- 1ST APRIL
2014Development, manufacture and regulation of pre-filled syringe and injector devices
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Pre-Filled SyringesAmericas
KEY SPEAKERS INCLUDE:• Scott Brown, Device Development Lead, Merck • Alexei Goraltchouk, Senior Manager, Operations, Regeneron• Stephen Barat, Senior Director, Toxicology and Operations, Forest
Laboratories• Steven Projan, SVP, MedImmune*• Martin Dearden, Chief Corporate Microbiologist, UCB• Thomas Osterberg, Senior Manager, Biologics, Pfizer Inc• Greg Sacha, Senior Research Scientist, Baxter• Christian Siegmund, Head of Prefilled Syringes and liquid vials, Roche• Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA
Senior Executive
www.pfsamericas.com REGISTER BY 20TH DECEMBER 2013 AND SAVE $300 / REGISTER BY 28TH FEBRUARY 2014 AND SAVE $100
Register online or call +448709090711 to speak to an account executive
ne.co.uk
, by one ofe. Bookingsof payment
2R 8AU
□□
EX card
tions,
Total
£598.80£499.00
erence price
rence price
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VAILABLE
Fee$2398.00$1799.00$599.00
$1598.00$999.00$599.00
£1198.80
access
Sponsored by
REGIST
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20TH
DEC
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AND SAVE $
300
REGIST
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Y 28T
H FEBR
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AND SA
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“A wise choice of location and an intelligently designed program of expertspeakers promises to bring together the leading minds and influencers mappingthe future of the prefilled syringes sector.” Guy Furness, Proprietor & Publisher, ONdrugDelivery Magazine
*stc
P-114_5__ 21/11/2013 11:59 Page 3
Register online at: www.pfsamericas.com • Alternatively fax your registr
Pre-Filled Syringes AmericasDay One | Monday 31st March 2014 www.pfsamericas.
8.30 Registration & Coffee
9.00 Chairman's Opening RemarksAlexei Goraltchouk, Senior Manager, Operations Regeneron
9.10 KEYNOTE ADDRESS: Avoiding the pitfalls of device development•What to look out for when developing your delivery device•The 5 reasons product fail •How can you plan to mitigate the risk of product failuresScott Brown, Device Development Lead, Merck
9.50 HEADLINE PANEL: Developments in pre filled syringes and injection devices•What are key aspects driving the exponential
growth of the market?•Which challenges need to be worked out to continue
expansion? •What’s next for pre filled syringes, where will the growth come
from?Steven Projan, SVP, MedImmune (STC)Lloyd Fishman, President, High Peaks Partners LLCMichael Dudley, CEO, Artemes TechnologiesModerator: Cliff Mintz, Associate Editor, Life Science Leader
10.40 Morning refreshments and networking in the exhibition area
DEVELOPING YOUR COMBINATION PRODUCTS OR INJECTABLE DEVICE
11.10 Foreign Particulate Matter and Siliconization Testing•rap.ID and Foreign Particulate Matter Identification•Siliconization Process – Spray on vs. Emulsion•Silicone Control Methods – Historical and Actual•Layer Explorer – Technology and Case StudiesOliver Valet, President, rap.ID
11.50 Next generation Pre-Filled Syringes: How are electronic autoinjectors changing the market?•Trends in electronic injectors and how they compare to
pre-filled syringes•What are the key procurement challenges that category
managers will face•How these differ from conventional Pre Filled Syringe
challengesChanderkanth Gautam, Senior Research Analyst, Beroe IncGeetha Vaithyanathan, Domain Lead, Beroe Inc
12.30 Networking Lunch held in the exhibition area
2.00 Introduction to Medical grade Cyclo Olefin Polymers (COP)
•Key properties of current Medical grade Cycloolefin polymer
(COP)
•Regulatory Status
•Bio-Compatibility and Protein Adsorption study
•Effect of Gamma/EB/Steam sterilization
•Introduction of new product
Toshiro Katayama, Product Manager, Zeon Chemicals
2.40 Panel: Developing delivery systems for biological
products
•Overcoming viscosity and needle size challenges
•How can you ensure E&L are within acceptable
limits?
•Seeking efficient FDA approval for RA and other drug products
•When should you develop your own solution and when should
you work with a partner?
Dr Thomas Osterberg, Senior Manager, Biologics, Pfizer
Martin Dearden, Corporate Microbiologist, UCB
William Lambert, Fellow, Drug Delivery and Device
Development, MedImmune
Moderator: Cliff Mintz, Associate Editor, Life Science Leader
3.30 Afternoon refreshments and networking in the exhibition area
4.00 Pre-filled syringe manufacturing, a review of processes and
challenges
•New challenges with COP and COC containers
•How to effectively reduce particle contamination
•When’s the right time in product development to decide on
delivery systems?
Greg Sacha, Senior Research Scientist, Baxter
4.40 Cutting edge developments in pre filled syringe design soon to
be ready for testing
•How are advances in syringe design going to open the market
for new applications in PFS
•Developments in 2 chamber syringes capable of mixing
powders and liquids
•Advances in large polymer syringes with the capacity to
administer of nutritional gels
Michael Spigarelli, Professor of Internal Medicine, Pediatrics and
Pharmacy, University of Utah School of Medicine
5.20 Chairman's Closing Remarks and Close of Day One
Sponsored by Official Platinum Media Partner
Official Leading Media Partner
rap.ID Particle Systems GmbH rap.ID Particle Systems provides compliant solutions for the control of silicone and other lubricantsthickness and distribution in pre-filled syringes. rap.ID also offers contract testing servicesproviding particles identification and root cause analysis. rap.IDs good particle ID equipmentreveals enumeration as well as the chemical structure and elements of microparticles. Thisbecoming a standard in the identification of foreign particulate matter with a unique speed andpower of distinction. www.rap-id.com
Zeon Europe GmbHAchieve glass-like transparency and excellent long-term stability with protein- and peptide-based drugs by using ZEONEX®. ZEONEX® cyclo-oleflin polymers, break-resistant plasticsdesigned for critical pharmaceutical packaging applications including vials, pre-filled syringes,and blister packaging. ZEONEX® COP is an ultra-clean plastic that does not contain additives orcomponents that leach-out over time. Additionally, for protein-based drugs, common proteinsshow low adsorption onto ZEONEX containers as compared to other plastics. For moreinformation, visit www.zeonex.com or email [email protected]
PANEL
PANEL
P-114_5__ 21/11/2013 11:59 Page 4
y fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Pre-Filled Syringes AmericasDay Two | Tuesday 1st April 2014.pfsamericas.com
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REGULATORY SESSIONS: HOW YOU CAN ENSURE EFFICIENT APPROVAL
9.00 Chairman's Opening Remarks
Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior
Executive
9.10 Managing the safety assessment of leachables for pre-filled
syringe drug products
•Current trends in the safety assessment of extractables and
leachables.
•The use of scientifically-justified threshold levels in the safety
assessment of leachables
•How to approach the qualification of leachables and
considerations needed during development and life-cycle
management.
•Working examples to illustrate approach and key principles.
Stephen Barat, Senior Director, Toxicology and Operations, Forest
Laboratories
9.40 Getting to market: Regulatory perspective
•Defining a pre-filled syringe as a product or device and its
impact on regulatory approval
•Roadmap to approval for PFS’s and auto injectors
•Insight into the FDA’s current thoughts
Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior
Executive
10.10 Morning refreshments and networking in the exhibition area
10.40 Considerations to gain international regulatory approval
•Considerations to make when developing your manufacturing
facility
•Overcoming the challenges of the Japanese market?
•Planning for success in multiple regions
Brij Patel, CEO, RegExcel
11.20 How should you manage your biological assessment of medical
devices
•Safety evaluations of E&L
•Adhering to regulations in the EU and beyond
•Benefits and pit falls of different container materials
Adam Wooley, CEO, ForthTox
12.00 Networking Lunch held in the exhibition area
OVERCOMING MANUFACTURING CHALLENGES OF PRE-FILLED SYRINGES AND INJECTOR DEVICES
1.30 The market and technologies for large volume (‘bolus’) injections
•Findings from study conducted in conjunction with the
Cambridge Judge Business School
•New drugs that require large injections: Why are bolus injectors
are required?
•The limitations of autoinjectors and infusion pumps for large
volume injections
•Why a new class of device, the bolus injector, is under
development
•Example devices and their properties– Unilife, BD, West, Ratio,
SteadyMed etc.
Tom Oakley, Director of Drug Delivery Device Development,
Springboard
2.10 Case Study: Benefits and challenges of pre-filled syringe isolator
filling machines
•Latest updates on how to overcome challenges
•Minimization of product errors and scratches
•Overcoming the challenges of machine start ups
•Methods of inspection: Visual and automated machines
Christian Siegmund, Head of Prefilled Syringes and liquid vials,
Roche
2.50 Afternoon refreshments and networking in the exhibition area
3.20 Developing your fill and finish production lines
•Upcoming trends in fill and finish functionality
•Adhering to visual inspection guidelines
•Considerations for international export markets
Martin Dearden, Chief Corporate Microbiologist, UCB
4.00 Future trends in the pre filled syringes and medical devices
•Delivery technology, business and operational needs from the
drug-makers perspective
•Usability, user preference, and learning from patient feedback
•The next generation of needs, as opposed to the next
generation technology
Alexei Goraltchouk, Senior Manager, Operations Regeneron
4.40 Chairman’s Closing Remarks and Close of Day Two
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PANEL
P-114_5__ 21/11/2013 11:59 Page 5
HALF-DAY POST-CONFERENCE WORKSHOPWednesday 2nd April 2014
8.30am - 12.30pmRenaissance Woodbridge, Iselin, New Jersey, USA
Accelerating the regulatory approval ofyour pre-filled product : Insight into
combination product approvals
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Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel
Mr. Sall, Principal Consultant, ParExel
Workshop overview:Run by one of the US’s leading figures in regulatoryapproval processes and drug delivery systems, Dr.Ravi Harapanhalli. This industry leading workshop willhelp you plan for smooth regulatory approvals andhelp with avoiding pitfalls that can cause expensivedelays in taking your product to market.
Why you should attend:• Accelerate the time it takes to take your drug
delivery system to market• Find out how to navigate new combination
product guidelines• Assess the right time to start thinking about your
drug delivery mechanism• Develop a strategy for product life cycle
management by switching over to PFS• Understand how to apply the FDA Quality System
Regulation to delivery device development• Know how to apply FDA Design Controls to
delivery device development• Get to appreciate how to selection of a delivery
device development partner• Perform risk analysis and Human Factors
assessment
Programme9.00 Registration
9.30 Introductions and Opening Remarks
9.45 Session 1: Quality-by-Design in thedevelopment of drug delivery systems
10.30 Session 2: Regulatory pit falls to avoid
11.00 Coffee break
11.30 Session 3: New combination productregulations and how to comply with them
12.00 Session 4: How to accelerate approvalthrough FDA
12.30 End of Workshop
About the workshop host Dr. Ravi Harapanhalli advisesbio/pharmaceutical companies onCMC regulatory strategies and Quality-by-Design approaches to medicinalproduct development and flexibleregulatory approaches.
About the workshop co-leaderMr. Sall is a Principal Consultant withPAREXEL Consulting in Waltham, MA.PAREXEL provides clinical trial, clinicaldata management, medical and reg-ulatory services to the pharmaceuticaland medical device industries.
About ParExelOver the past 30 years, ParExel has developedsignificant expertise to assist clients in the worldwidepharmaceutical, biotechnology and medicaldevice industries with the development and launchof their products in order to bring safe and effectivetreatments to the global marketplace for the patientswho need them. Headquartered near Boston,Massachusetts, ParExel operates over 77 locationsthroughout more than 51 countries around the world,and has over 14,400 employees.
P-114_5__ 21/11/2013 12:00 Page 6
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
Imagine a room full of the highestlevel decision-makers from your
target market...
SMi offer sponsorship, advertising andbranding packages, uniquely tailored tocompliment your company's marketingstrategy. Prime networking opportunitiesexist to entertain, enhance and expandyour client base within the context of anindependent discussion specific to your
industry.
Expected audience at Pre-Filled Syringes Americas:
Conferenc
If you
■ North America
■ Europe
■ Asia
■ Rest of World
Audience by Location
Audience by Sector
SPONSORSHIP ENQUIRIES Should you wish to join the increasing number of companies benefiting from sponsoring our
conferences please call: Alia Malick, Director on +44 (0) 20 7827 6168 or
email: [email protected]
Want to know how you can get involved? Interested in promoting your services
to this market?Contact Julia Rotar, SMi Marketing on
+44 (0) 207 827 6088, or email: [email protected]
■ Bio Tech/Pharma
■ Pre-Filled Systems
■ Pre-FilledComponents
■ ProductEquipment
P-114_5__ 21/11/2013 11:58 Page 1
FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
PRE-FILLED SYRINGES AMERICAS Conference: Monday 31st March & Tuesday 1st April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshop: Wednesday 2nd April 2014, London
4 WAYS TO REGISTERwww.pfsamericas.com
Workshop L
REGISTE
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at [email protected]
Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then creditcard details will be requested and payment taken before entry to the event. Bookings within 7 daysof event require payment on booking. Access to the Document Portal will not be given until paymenthas been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.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 £50 administration charge, providingthat 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 theconferences documentation via the Document Portal to any delegate who has paid but is unableto attend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther 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 ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager [email protected] or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.
Unique Reference Number
Our Reference LV P-114
Terms and Conditions of Booking
DELEGATE DETAILSPlease complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
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Signature: Date:I agree to be bound by SMi's Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
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Payment must be made to SMi Group Ltd, and received before the event, by one ofthe following methods quoting reference P-114 and the delegate’s name. Bookingsmade within 7 days of the event require payment on booking, methods of paymentare below. Please indicate method of payment:
A/C Name SMI GROUP LTD Sort Code 300009,Account Number 11775391 CCY USD□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
IBAN GB75LOYD30000911775391BIC LOYDGB21013
□ Cheque We can only accept cheques in US Dollars.□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□Valid From □□/□□ Expiry Date □□/□□CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
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DOCUMENTATIONUnable to travel, but would like to watch the conference live, ask questions,participate as if you were in the room.
Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80□ The Conference Presentations - paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
□ Book by 20th December to receive a $300 discount off the conference price
□ Book by 28th February to receive a $100 discount off the conference priceEARLY BIRDDISCOUNT
VAT
VAT at 20% is charged on Document Portal and literature distribution for all UK customers andfor those EU Customers not supplying a registration number for their own country here______________________________________________________________________________________________
CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE
I would like to attend: (Please tick as appropriate) Fee□ Conference & Workshop $2398.00□ Conference Only $1799.00□ Workshop Only $599.00Pharmaceutical Companies Rates: LIMITED AVAILABILITY□ Conference & Workshop $1598.00□ Conference Only $999.00□ Workshop Only $599.00PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers and access
to the Document Portal containing all of the presentations.
VENUE Renaissance Woodbridge Hotel, 515 U.S. Route 1, Iselin, NJ 08830
□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711, email: [email protected] or fax +44 (0) 870 9090 712
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AND SAVE $
30
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