4th Pre-Filled Syringes                    Addressing the multifaceted challenges for efficacious products 17th – 19th Oct...
Conference Introduction                                                                                                   ...
Pre-Conference Interactive Workshop                                                                                       ...
Day 1                                                                                                                     ...
Day 2                                                                                                   4th Pre-Filled Syr...
Registration Form                                                                                                         ...
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4th Pre Filled Syringes (2011) Pp


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4th Pre Filled Syringes (2011) Pp

  1. 1. 4th Pre-Filled Syringes Addressing the multifaceted challenges for efficacious products 17th – 19th October 2011, Visiongain Conference Centre, London, UK BOOK NOW! Key Speakers 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 Pre-conference Workshop, Monday 17th October, 2011 Extractables and Leachables Led by: Dr Andrew Feilden, Senior Scientist, AstraZenecaAssociate Sponsor Organised By Driving the Industry Forward | www.futurepharmaus.comMedia Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/syringes
  2. 2. Conference Introduction 4th Pre-Filled Syringes 17th - 19th October 2011, London, UK Dear Colleague, Associate Sponsor: SCHOTT Pharmaceutical Systems is one of the world’s re-Filled syringes constitutes one of the fastest growing markets in the drug delivery P leading suppliers of glass tubing and primary packaging and packaging sectors with total revenues in this market expected to reach $5.5bn in for the pharmaceutical industry. We provide our customers 20251. This is driven by a marked rise in the success of biological drugs and vaccine quality solutions while meeting their highest demands with market expansion. our material expertise, specialized analytical lab services, and a broad product ith the prospect of easier administration, reduced risk of detrimental occurrences and W portfolio; including syringes, cartridges, vials, ampoules, and special articles made of cost-effectiveness, its no wonder Pre-filled syringes are fast becoming the drug delivery glass and COC polymer. With four glass tubing production sites and fifteen sites for system of choice. pharmaceutical packaging spread over four continents, we offer safe supply and local service. Our state-of-the-art production facilities and our products comply with the oin us at Visiongain’s 4th Pre-filled syringes conference and gain insight into a J highest international quality standards for pharmaceutical needs. spectrum of topical issues ranging from manufacture, formulation and drug identity to For further information please visit: www.schott.com quality, safety and novel pre-filled syringe technologies. on’t miss this wonderful opportunity to further your knowledge in an interactive D Media Partners: learning environment and network with diverse leaders in the industry! PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading Reasons to register today: pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, • Understand current market dynamics: prospects for the future events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com • Analyse manufacturing options: ready to fill vs bulk syringes BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. • Inspect formulation issues It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market • Gain advice on overcoming regulatory and technical hurdles to make it universally accessible and useful for scientific and business processes. Its first • Investigate compatibility issues: avoiding changes in product quality step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers • Explore approaches to ensure drug identity, potency and sterility companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector • Survey end user compliance: implications, requirements and opportunities in Europe to global biotechnology, pharmaceutical and life science activities. • Utilise strategies to ensure quality and safety of prefilled syringes For further information please visit: www.biotechnology-europe.com Driving the Industry Forward | www.futurepharmaus.com • Explore pre-filled syringes for leachables: the suitability for use issues Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, • ain insights in to the healthcare professional’s perspective: problems at the G and for senior decision-makers to have the means to procure and plan implementation forefront strategies based on the topics covered. Positioned to be an authoritative resource within top • Discover novel pre-filled syringe technology pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the I look forward to meeting you at the conference gap between the industries’ top issues and the solutions top-tier vendors can provide. Best regards For further information please visit: www.futurepharmaus.com InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.inpharm.com Nima Farah Conference Producer Poster Presentation At a busy conference it is hard to make sure everyone who shares your interests knows what you are doing. Maximise your time at Visiongain’s 4th Pre-Filled Syringes meeting by sharing your results in a poster presentation. With a plethora of key decision makers, take advantage of this senior networking opportunity. Who should attend? Please send your 200 word abstract, in English, to: info@visiongainglobal.com for Presidents, Chief Executive Officers, VPs, Global Heads, Chief approval. The deadline for submissions is Wednesday 28th of September 2011. Please Scientific Officers, Directors, Principal Scientists, Franchise Heads and include contact details for the corresponding author(s). Investigators in: Academic institutions will not be charged a fee if booked as full-price delegates. Posters • High-Throughput/High-Content Screening Operations submitted by pharmaceutical and biotechnology firms will be charged a fee of £199. • Bioanalytical Development Posters submitted by service providers / vendors are welcome and will be subject to • Compound Profiling evaluation. Upon approval a fee of £500 will apply. Two delegates from your organisation must be booked at full price to present a poster. • Drug Discovery/Validation • Cellular Imaging Please note that all posters will be displayed at the discretion of Visiongain Ltd and are • Lead Generation subject to approval. Due to limited space, please register your interest early. • In Vitro Sciences • ADMET • Pre-clinical Development Sponsorship and exhibition opportunities • Medicinal Chemistry This event offers a unique opportunity to meet and do business with some of the key • Toxicology players in the pharmaceutical and biotech industries. If you have a service or product to • Stem Cell Technologies & Platforms promote, you can do so at this event by: • Pharmacovigilance and Safety Testing • Hosting a networking drinks reception • Chemistry and Bioapplications • Taking an exhibition space at the conference • GPCR/Kinases/Molecular Pharmacology • Advertising in the delegate documentation pack • External/Contract Research • Providing branded bags, pens, gifts, etc. • Pharmacokinetics/Pharmacodynamics If you would like more information on the range of sponsorship or exhibition possibilities • Cellular Research and Development for visiongains 4th Pre-Filled Syringes Conference, please contact us: • Business Development Damian Gorman, +44 (0)20 7549 9934 • Investment and Venture Capital damian.gorman@visiongainglobal.comPre-Filled Syringes and Related Systems: World Market Outlook 2010-2025, VISIONGAIN1
  3. 3. Pre-Conference Interactive Workshop 4th Pre-Filled Syringes Monday 17th October 2011 Extractables and LeachablesLed by: Dr Andrew Feilden Timings: 9:30 - 10:00 Coffee & Registration 0 Senior Scientist 10:00 - 15:00 Workshop AstraZeneca T iming includes lunch and refreshment breaksAbout the workshop About your workshop leaders:The purpose of the workshop is to allow you to engage in knowledge Dr Andrew Feildensharing with your peers in a smaller, less formal environment than themain conference. As such, the audience size will typically be no more Dr Andrew Feilden, is currently a senior scientist within Analyticalthan 20 participants in order to enable maximum interaction betweenthe workshop leaders and the delegates. The format is also more Science at AstraZeneca Charnwood, has been working in the field ofinteractive, with less emphasis on ‘lecture-style’ presentations and more trace analysis using hyphenated techniques such as GC-MS and LC-MSemphasis on group discussions, exercises and Q&A sessions. for over 12 years. Andrew currently leads the extractable and leachableAgenda: testing within AstraZeneca and is an active member of both the IPAC-• Introduction RS container closure group and is the co-chair of ELSIE material group.• Regulatory Requirements Andrew gained a degree and D.Phil from York University. Andrew will be - Current guidelines, recommendations and best practises• How to carry out extractable and leachable testing moving to join Smithes Rapra in June 2011 as a Principal Consultant. - Types of studies - Techniques to use About visiongain: Visiongain is a specialist business information company focused on providing - Limits of detection required 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• Industry working groups consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, - What groups are there and what are they doing providing the right information at the right time to facilitate the commercial decision-making process. Our pharmaceutical products include Pharma• Hypothetical E&L Case Study 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• Extractable and leachable risk assessment pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for• Change management pharmaceutical professionals from around the world. For further information, please visit: www.visiongain.com
  4. 4. Day 1 4th Pre-Filled Syringes Tuesday 18th October 2011 09:00 Registration and refreshments 13:40 Pre-filled syringes: the regulatory aspects • Overview of regulatory requirements 09:30 Opening address from the chair • Review latest developments • How to meet requirements • Case Studies 09:40 Formulation development and product image Dr Vikas Jaiteley • Target product profile and key marketing targets Pharmaceutical Assessor and Deputy Manager • Specific formulation issues MHRA • The pharmacist/Nurse/Practitioner angle • Stability assessment 14:20 Overcoming regulatory and technical hurdles: the • Product differentiation, the medicines vision legal perspective • Future plans • Regulatory challenges within: - Formulation Paul J Cummings - Stability Executive Director - Clinical PJC Pharma Consulting Ltd - Filling • Overview of technical challenges 10:20 Manufacturing options • Summary • Ready to fill vs bulk pre-filled syringes: Liz Fuller - Comparison of manufacture process Partner Bird & Bird LLP - Pros and cons • Glass vs plastic pre-filled syringes: 15:00 Afternoon refreshments - Reaching a decision - Pros and cons 15:20 Extractable and Leachable studies for pre-filled - Alternative primary packaging syringes: how to step-up the right testing strategy? • hat is the importance of extractable/leachable studies (safety, W 11:00 Morning refreshments regulatory requirements) • ow can supplier information assist you in the design of an extractable H study and what pitfalls should be avoided 11:20 Microbiology in filling and sterility test isolators • How to assess the results of an extractable study • Bringing an isolator under microbiological control • How to carry out a leachable study, how to assess these results • How to achieve a state of “practically free of micro-organisms” • Case studies • Control of an isolator with physical and microbiological monitoring Dr Piet Christiaens • Maintenance aspects and integrity checks of isolator systems Scientific director • Validation of an filling isolator with media fills Toxikon Europe • Microbiological problems in isolators 16:00 Toxicological assessment of leachables from Dr Christian Vogt container-closure systems: pre-filled syringes QA/QC Expert Microbiology • Brief overview of leachables and extractables Novartis • ackground on the need for safety evaluation of leachables from B container closure systems 12:00 Small batch filling applications • urrent initiatives and regulatory expectations related to leachable C • Filling of high potent drugs safety assessment • Working examples/case studies • Disposable filling system including introduction in to cleanroom area • Process improvements fill/finish Dr Stephen Barat Senior Director, Toxicology and Operations • Automation of critical process steps Forest Research Institute, A subsidiary of • Barrier systems including mock-up Forest Laborotories • Innovative fill/finish concepts for new pre-sterilised containers Klaus Ullherr 16:40 Closing remarks from the chair Product Manager Robert Bosch Packaging 12:40 Networking lunch 16:50 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting 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
  5. 5. Day 2 4th Pre-Filled Syringes Wednesday 19th October 201109:00 Registration and refreshments 14:20 Pre-filled syringe technology Senior Representative09:30 Opening address from the Chair Groninger & Co09:40 Advanced elastomeric components for 14:40 Presentation to be announced pre-filled syringes Horst Koller • Special concerns for elastomeric components Regulatory Affairs • Impact on material development Schott • Impact on component design • Advanced coating technology Omniflex CP 15:00 Afternoon refreshments • Standardisation of elastomeric PFS components Patrick Grueninger 15:40 CT Radiographers’ Perspective (thoughts from the Global Marketing & Business Development Manager Helvoet Pharma coal face) • How do we use pre-filleds in a CT department10:20 Visual inspection in pre-filled syringes - Iodinated contrast media • Requirement of inspection - Intravenous injection via pump injector • Manual/semi-automated/automated inspection • Clinical task • Insights into inspection environment and process for prefilled syringes • Case study - Number and range of scans Norman Gray - Safety and quality issues Inspector • Advantages of pre-filleds MHRA - Time benefits/improved throughput - Safety11:00 Morning refreshments - Hygeine - Storage/inventory issues11:20 End user compliance: implications, requirements and opportunities • Training issues • End user needs - Confidence and competence • Aspects of compliance - Challenge of different learning styles • Patient compliance studies - Use of core trainers • Market trends and health economics • Summary • Flexibility - Features that provide a safe/quality service in a dynamic environment12:00 Advanced formulations of biologics • Wish list • Degradation pathways of biologics - Features we would like in an ideal world! • Interactions of biologics with containers and other components Frank Ellwood • Control of biologics stability by formulation CT Superintendent • Advanced formulations of biologics Plymouth Hospitals NHS Trust • Stable liquid formulations for prefilled syringes • High concentration antibodies 16:00 Novel technology to offer an additional benefit to Dr Jan Jezek Chief Scientific Officer the customer Arecor Matthew Young and Dr Catherine Beech Chief Executive Officer, Director 12:40 Networking lunch Oval Medical Technologies13:40 Approaches to ensure drug identity, potency and quality 16:40 Chair’s closing remarks • Pre filled syringes as a delivery device and storage container • Ensuring drug potency 16:50 End of conference • Stability studies • Drug safety • Summary Dr Wolfgang Papst Device Development Novartis
  6. 6. Registration Form 4th Pre-Filled Syringes 17th - 19th October 2011, London, UK Angel Conf. code Pentonville Road 4th Pre-Filled Syringes CiStandard Prices ty Ro adConference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80 17th - 19th October 2011Conference only Fee: £1299 VAT: £259.80 Total: £1558.80 Old StreetWorkshop only Fee: £599 VAT: £119.80 Total: £718.80 Location: Visiongain Conference Centre Old StreetNumber of bookings: Total cost: Address: 230 City Road London City Road EC1V 2TTPromotional Literature Distribution UKDistribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80 How to bookDetails Email: piyush.patel@visiongain.com Forename: Surname: Web: http://www.visiongain.com/syringes UK Office:Job Title: Company: Tel: +44(0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd 230 City Road LondonAddress: EC1V 2QY UK General information Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Country: Postcode: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 Phone: Fax: 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 Email: 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once Methods of payment made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice Payment must be made in sterling must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences. However, if you cannot attend the conference, you may make a substitution/name By Mail: Complete and return your signed registration form together with your cheque payable change at any time, as long as we are informed in writing by email, fax or post. Name changes and to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK substitutions must be from the same company or organisation and are not transferable between countries. Please note that discounted delegates places at a visiongain event are non refundable.By Fax: Complete and fax your signed registration form with your credit card details Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, to +44 (0) 20 7549 9932 excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made.By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try By Bank Transfer: to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the Barclays Bank Sort Code: 20-71-64 cost of the registration, travel and expenses.Piccadilly Branch Account No: 6038 7118 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data 48 Regent Street Swift Code: BARC GB22 Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We London, W1B 5RA IBAN: GB80 BARC 20716460387118 may also share your data with external companies offering complementary products or services. If you wish for your details to be amended, suppressed or not passed on to any external third party, please Please debit my credit card: send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Access MasterCard Visa American Express EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect.Card number: Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).Expiry Date: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Security number (last 3 digits on back of credit card): Eurocash specialise in recovering cross-border VAT. How we will contact you: Visiongain Ltd’s preferred method of communication is by email and Signature: phone. Please ensure that you complete the registration form in full so that we can contact you. Unable to attendCardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive speaker talks in PDFs two weeks after the event.News updates Yes, please send me speaker talks Price£550 VAT:£110 Total:£660Please tick if you do not want to receive email news updates in the future www.visiongain.com/syringes