17th – 19th October 2011, Visiongain Conference Centre, London, UK Organised By Addressing the multifaceted challenges for efficacious products To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/syringes Dr Andrew Feilden, Senior Scientist, AstraZeneca Dr Wolfgang Papst, Device development, Novartis Dr Christian Vogt, QA/QC Expert Microbiology, Novartis Dr Torsten Richter, Project co-ordinator, Bayer Dr Vikas Jaiteley, Pharmaceutical Assessor and Deputy Manager, MHRA Norman Gray, Inspector, MHRA Klaus Ullherr, Product Manager, Robert Bosch Packaging Horst Koller, Regulatory Affairs, Schott Senior Representative, Groninger & Co Patrick Grueninger, Global Marketing & Business Development Manager, Helvoet Pharma Dr Jan Jezek, Chief Scientific Officer, Arecor Matthew Young, CEO, Oval Medical Technologies Liz Fuller, Partner, Bird & Bird LLP Paul J Cummings, Executive Director, PJC Pharma Consulting Frank Ellwood, CT Superintendent, NHS Dr Stephen Barat, Senior Director, Toxicology and Operations, Forest Research Laborotories Key Speakers BOOK NOW! 4th Pre-Filled Syringes Driving the Industry Forward | www.futurepharmaus.com Media Partners Pre-conference Workshop, Monday 17th October, 2011 Extractables and Leachables Led by: Dr Andrew Feilden, Senior Scientist, AstraZeneca Associate Sponsor
Transcript
17th – 19th October 2011, Visiongain Conference Centre, London, UK
Organised By
Addressing the multifaceted challenges for efficacious products
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/syringes
Dr Andrew Feilden, Senior Scientist, AstraZeneca
Dr Wolfgang Papst, Device development, Novartis
Dr Christian Vogt, QA/QC Expert Microbiology, Novartis
Dr Torsten Richter, Project co-ordinator, Bayer
Dr Vikas Jaiteley, Pharmaceutical Assessor and Deputy Manager, MHRA
Norman Gray, Inspector, MHRA
Klaus Ullherr, Product Manager, Robert Bosch Packaging
Horst Koller, Regulatory Affairs, Schott
Senior Representative, Groninger & Co
Patrick Grueninger, Global Marketing & Business Development Manager, Helvoet Pharma
Dr Jan Jezek, Chief Scientific Officer, Arecor
Matthew Young, CEO, Oval Medical Technologies
Liz Fuller, Partner, Bird & Bird LLP
Paul J Cummings, Executive Director, PJC Pharma Consulting
Frank Ellwood, CT Superintendent, NHS
Dr Stephen Barat, Senior Director, Toxicology and Operations, Forest Research Laborotories
Key Speakers
BOOK NOW!
4th Pre-Filled Syringes
Driving the Industry Forward | www.futurepharmaus.com
Join us at Visiongain’s 4th Pre-filled syringes conference and gain insight into aspectrumoftopicalissuesrangingfrommanufacture,formulationanddrugidentitytoquality,safetyandnovelpre-filledsyringetechnologies.
Don’t miss this wonderful opportunity to further your knowledge in an interactivelearningenvironmentandnetworkwithdiverseleadersintheindustry!
•Gain insights in to the healthcare professional’s perspective: problems at theforefront
•Discovernovelpre-filledsyringetechnology
Ilookforwardtomeetingyouattheconference
Bestregards
Nima Farah Conference Producer
Who should attend?Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific Officers, Directors, Principal Scientists, Franchise Heads and Investigators in:
• High-Throughput/High-Content Screening Operations• Bioanalytical Development • Compound Profiling • Drug Discovery/Validation• Cellular Imaging• Lead Generation• In Vitro Sciences• ADMET• Pre-clinical Development• Medicinal Chemistry• Toxicology• Stem Cell Technologies & Platforms• Pharmacovigilance and Safety Testing• Chemistry and Bioapplications• GPCR/Kinases/Molecular Pharmacology• External/Contract Research• Pharmacokinetics/Pharmacodynamics• Cellular Research and Development• Business Development• Investment and Venture Capital
ourmaterialexpertise,specializedanalyticallabservices,andabroadproductportfolio;includingsyringes,cartridges,vials,ampoules,andspecialarticlesmadeofglassandCOCpolymer.Withfourglasstubingproductionsitesandfifteensitesforpharmaceuticalpackagingspreadoverfourcontinents,weoffersafesupplyandlocalservice.Ourstate-of-the-artproductionfacilitiesandourproductscomplywiththehighestinternationalqualitystandardsforpharmaceuticalneeds.For further information please visit: www.schott.com
pharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: [email protected]
wasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com
andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.For further information please visit: www.futurepharmaus.com
For further information please visit: www.inpharm.com
Driving the Industry Forward | www.futurepharmaus.com
Sponsorship and exhibition opportunitiesThiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain's4thPre-FilledSyringesConference,pleasecontactus:
Dr Andrew Feilden, is currently a senior scientist within Analytical
Science at AstraZeneca Charnwood, has been working in the field of
trace analysis using hyphenated techniques such as GC-MS and LC-MS
for over 12 years. Andrew currently leads the extractable and leachable
testing within AstraZeneca and is an active member of both the IPAC-
RS container closure group and is the co-chair of ELSIE material group.
Andrew gained a degree and D.Phil from York University. Andrew will be
moving to join Smithes Rapra in June 2011 as a Principal Consultant.
About the workshop
The purpose of the workshop is to allow you to engage in knowledge
sharing with your peers in a smaller, less formal environment than the
main conference. As such, the audience size will typically be no more
than 20 participants in order to enable maximum interaction between
the workshop leaders and the delegates. The format is also more
interactive, with less emphasis on ‘lecture-style’ presentations and more
emphasis on group discussions, exercises and Q&A sessions.
Agenda:
• Introduction
• Regulatory Requirements
- Current guidelines, recommendations and best practises
• How to carry out extractable and leachable testing
- Types of studies
- Techniques to use
- Limits of detection required
• Industry working groups
- What groups are there and what are they doing
• Hypothetical E&L Case Study
• Extractable and leachable risk assessment
• Change management
About visiongain: Visiongain is a specialist business information company focused on providing cutting edge products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and Finance sectors, which include reports, conferences, online daily news and offline news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial decision-making process. Our pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for pharmaceutical professionals from around the world.
For further information, please visit: www.visiongain.com
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Formulation development and product image
•Targetproductprofileandkeymarketingtargets
•Specificformulationissues
•Thepharmacist/Nurse/Practitionerangle
•Stabilityassessment
•Productdifferentiation,themedicinesvision
•Futureplans
Paul J Cummings ExecutiveDirectorPJC Pharma Consulting Ltd
10:20 Manufacturing options
•Readytofillvsbulkpre-filledsyringes:
-Comparisonofmanufactureprocess
-Prosandcons
•Glassvsplasticpre-filledsyringes:
-Reachingadecision
-Prosandcons
-Alternativeprimarypackaging
11:00 Morning refreshments
11:20 Microbiology in filling and sterility test isolators
Dr Stephen Barat SeniorDirector,ToxicologyandOperationsForest Research Institute, A subsidiary of Forest Laborotories
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 14th Pre-Filled Syringes
Tuesday 18th October 2011
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
Day 24th Pre-Filled Syringes
Wednesday 19th October 2011
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 Advanced elastomeric components for pre-filled syringes
13:40 Approaches to ensure drug identity, potency and quality •Prefilledsyringesasadeliverydeviceandstoragecontainer •Ensuringdrugpotency •Stabilitystudies •Drugsafety •Summary
Dr Wolfgang Papst DeviceDevelopmentNovartis
14:20 Pre-filled syringe technology
Senior Representative Groninger & Co
14:40 Presentation to be announced
Horst Koller RegulatoryAffairsSchott
15:00 Afternoon refreshments
15:40 CT Radiographers’ Perspective (thoughts from the coal face)
Frank Ellwood CTSuperintendentPlymouth Hospitals NHS Trust
16:00 Novel technology to offer an additional benefit to the customer
Matthew Young and Dr Catherine Beech ChiefExecutiveOfficer,DirectorOval Medical Technologies
16:40 Chair’s closing remarks
16:50 End of conference
How to bookEmail:[email protected]:http://www.visiongain.com/syringes
UK Office:Tel: +44(0)207549 9961Fax:+44(0)2075499932 VisiongainLtd230CityRoadLondonEC1V2QYUK
General informationVenue:Venue:Directions:VisiongainConferenceCentre230CityRoad,London,EC1V2TT.UnitedKingdom.ClosesttubestationisOldStreet(NorthernLine).Accommodation:ThistleCityBarbican,CentralStreet,Clerkenwell,London,EC1V8DS,Phone:08713769004/+448453058304,Fax:08713769104/+448453058343http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.htmlTravelodgeLondonCityRoadHotel,7-12CityRoad,London,EC1Y1AE,Tel:08719846333,Fax:02076282503,http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Substitutions/name changes or cancellations: Thereisa50%liabilityonallbookingsoncemade,whetherbypost,fax,emailorweb.Thereisanorefundpolicyforcancellationsreceivedonorafteronemonthbeforethestartoftheevent.Shouldyoudecidetocancelafterthisdate,thefullinvoicemustbepaid.Conferencenoteswillthenbesenttoyou.Unfortunately,weareunabletotransferplacesbetweenconferences.However,ifyoucannotattendtheconference,youmaymakeasubstitution/namechangeatanytime,aslongasweareinformedinwritingbyemail,faxorpost.Namechangesandsubstitutions must be from the same company or organisation and are not transferable betweencountries.Pleasenotethatdiscounteddelegatesplacesatavisiongaineventarenonrefundable.
Invoice alterations:Therewillbeanadministrationchargeof£50foranychangestoaninvoice,excluding substitutions/name changes, requested by the customer. This will be charged to thecustomerbycreditcardpriortothechangesbeingmade.
Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executivebriefingcontent,timing,speakersorvenuewithoutnotice.TheeventmaybepostponedorcancelledduetounforeseeneventsbeyondthecontrolofvisiongainLtd.Ifsuchasituationarises,wewilltrytorescheduletheevent.However,visiongainLtdcannotbeheldresponsibleforanycost,damageorexpenses,whichmaybeincurredbythecustomerasaconsequenceoftheeventbeingpostponedorcancelled.Wethereforestronglyadviseallourconferenceclientstotakeoutinsurancetocoverthecostoftheregistration,travelandexpenses.
Data Protection: Visiongain Ltd gathers and manages data in accordance with the DataProtectionAct1988.YourpersonalinformationcontainedinthisformmaybeusedtoupdateyouonvisiongainLtdproductsandservicesviapost,telephone,faxoremail,unlessyoustateotherwise.Wemayalsoshareyourdatawithexternalcompaniesofferingcomplementaryproductsorservices.Ifyouwishforyourdetailstobeamended,suppressedornotpassedontoanyexternalthirdparty,pleasesendyourrequesttotheDatabaseManager,visiongainLtd,BSGHouse,226-236CityRoad,London,EC1V2QY.Alternatively,youcanvisitourwebsiteatwww.visiongain.comandamendyourdetails.Pleaseallowapproximately30daysforyourremovalorupdaterequesttobeappliedtoourdatabase.Followingyourremovalorupdaterequest,youmayreceiveadditionalpiecesofcommunicationfromvisiongainLtdduringthetransitionalperiod,whilstthechangesarecomingintoeffect.
Fee: Theconferencefeeincludeslunch,refreshmentsandconferencepapersprovidedontheday.This feedoesnot include travel, hotel accommodation, transfersor insurance, (whichwe stronglyrecommendyouobtain).
How we will contact you: VisiongainLtd’spreferredmethodofcommunicationisbyemailandphone.Pleaseensurethatyoucompletetheregistrationforminfullsothatwecancontactyou.
Unable to attendObviouslynothingcomparestobeingtherebutyouneednotmissout.Simplyticktheboxandsendwithyourpayment.YouwillreceivespeakertalksinPDFstwoweeksaftertheevent.
Yes, please send me speaker talks Price£550 VAT:£110 Total:£660
Conf.code
Standard PricesConference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
Workshop only Fee: £599 VAT: £119.80 Total: £718.80
Number of bookings: Total cost:
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