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4th Annual Contract Manufacturing (2010)
- 1. 4th Annual Contract Manufacturing Driving contract manufacturing through cost-effective outsourcing 13th – 14th December 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Martin P Grosvenor, Drug Delivery Manager, AstraZeneca Anthony Pettigrew, Analytical Development Manager, Novozymes Olivia Darmuzey, QbD Expert Pharmaceutical Operations, Novartis Mitch Rogers, Business Development Manager, Centre for Emergency Preparedness and Response, Health Protection Agency Prof Elaine Martin OBE, Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University Paul Smith, Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences Karen MacGregor, Product Development Director, Catalent Driving the Industry Forward | www.futurepharmaus.com Media Partners Organised By To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/cm
- 2. Conference Introduction 4th Annual Contract Manufacturing 13th - 14th December 2010, London UK Media Partners: Dear Colleague, PharmiWeb.com is the leading industry-sponsored portal for he global demand for contract manufacturing services and affordable outsourcing solutions T the pharmaceutical sector. Supported by most of the leading is increasingly driving the pharmaceutical companies to upgrade their technology and pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, manufacturing capacity. In recent times, investments in implementation of PAT and QbD features, events listings and international jobs to industry professionals across applications, to ensure high quality and timely supply, have become the prime focus of pharmaceutical and biotech industry. As the competition from off-patent products, in- Europe and the US. licensing and mergers and acquisitions grows, Asia is expected to become one of the largest For further information please email: corporate@pharmiweb.com cost-effective outsourcing markets in the next five years. isiongain’s 4th Annual Contract Manufacturing will provide tactical approaches and case V BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY studies to improve PAT and QbD implementation for a successful contract manufacturing WORLD. It is based and located in Warsaw, Poland. Biotechnology model. Delegates will learn regulatory and planning processes, best manufacturing practices, World was founded in 2007 to provide the world’s biotech and pharma information and strategies to maximise partnership with CMOs. and market to make it universally accessible and useful for scientific and business ur conference is a valuable opportunity to discuss, gain insights and network with thought O processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY leaders and key professionals from the industry. EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY Learn, discuss and gain insights on: EUROPE is to integrate the Biotech and Pharma Sector in Europe to global • Deliver successful external manufacturing supply chain and planning biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com • Learn trends, challenges and opportunities for manufacturing in Asia • Maximise opportunities as a consequence of FDA, PAT and QbD initiatives Future Pharmaceuticals has forged powerful relationships with Driving the Industry Forward | www.futurepharmaus.com • Evaluate outsourcing needs your business key industry leaders to provide a platform for successful brand • Implement strategies for successful analytical technology transfer recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an • Analyse critical issues affecting technology transfer & scale-up to QC authoritative resource within top pharma companies as well as small, specialty, • Understand QbD principles and continuous improvement in manufacturing and biotech, Future Pharmaceuticals magazine is geared to create a deep • Capitalise on the benefits of applying QbD approach in biologics contract manufacturing penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. • Formulate strategies to choose a right CMO partner For further information please visit: www.futurepharmaus.com • Integrate lean product development in a pharma CMO set-up • Understand the legal challenges and pitfalls for contract negotiation 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.In-Pharm.com ‘Pharma Connections Worldwide® is the leading professional Maninder Paul business networking website focused in the Pharmaceutical, Conference Producer Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘ Who will be there? For further information please visit www.pharmaconnections.com Directors, Heads of Department, Team Leaders and Scientists of: • Research and Development • PAT • QbD Sponsorship and exhibition opportunities: • CMC This event offers a unique opportunity to meet and do business with some of the • Process Development & Optimisation • Process Science/ Analytics key players in the pharmaceutical and biotech industries. If you have a service or • Manufacturing product to promote, you can do so at this event by: • Contracts & Outsourcing • Hosting a networking drinks reception • Formulation • Quality Assurance/Quality Control • Taking an exhibition space at the conference • Operations • Advertising in the delegate documentation pack • Strategic Alliances • Compliance • Providing branded bags, pens, gifts, etc. • Regulatory Affairs If you would like more information on the range of sponsorship or exhibition • Legal/ Patents possibilities for visiongain's 4th Annual Contract Manufacturing Conference, Pharmaceutical and Biotechnological Companies please contact us: Contract Manufacturing Organisations (CMOs) Ronald Magali, +44 (0)20 7549 9934 Drug Regulators, Intellectual Property/Law Firms Academia, Government Bodies, Regulatory Affairs ronald.magali@visiongainglobal.com
- 3. Day 1 4th Annual Contract Manufacturing Monday 13th December 2010 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair 13.40 The role of the analytical laboratory in 09:40 Applying QbD for the development and technology transfer manufacture of new products • ommon problems C • chieving QbD objectives A • ransfer strategy T • bD and continuous improvement in manufacturing Q • lanning the transfer P • esign space and control strategy D • he use of MVDA models to ensure quality compliance in routine production T • ase studies and learnings C livia Darmuzey O aul Smith P QbD Expert - PharmOps CH Validation Program Manager (Europe) Novartis Pharma PerkinElmer Life and Analytical Sciences 10:20 Identifying and exploiting opportunities from Process Analytical Technology (PAT) 14:20 From test tube to tank • xploiting on-line process analytical measurements to gain insight into E • ritical issues affecting technology transfer & scale-up C process performance • ddressing issues surrounding high containment manufacturing A • aking maximum use of a limited number of data sets in the CMO M environment • GMP production: Therapeutic products of prokaryote fermentation c • echniques to interpret data from instrumentation to assess on-line T itch Rogers M process quality Business Development Manager • kills required to maximise the benefits of PAT S Health Protection Agency rof Elaine Martin OBE P Professor of Industrial Statistics Biopharmaceutical and Bioprocessing Technology 15:00 Afternoon refreshments Centre, Newcastle University rof Gary Montague P Professor of Bioprocess Control 15:20 Validation, stability and method transfer Biopharmaceutical and Bioprocessing Technology activities to QC and contract manufacturers Centre, Newcastle University • evelop and validate new analytical test methodologies D • trategy and design for methods and complex investigations S 11:00 Morning refreshments • dentifying quality or safety issues I 11:20 Continuous manufacturing for oral solid dosage nthony Pettigrew A tablet making PAT application Analytical Development Manager Novozymes • AT as the key enabler to achieve QbD by means of ‘Model Predictive P Control’ and ‘Real Time Product Release’ • ow to deal with tracking and tracing when going from a batch to a H continuous process? 16:00 Risk mitigation strategies and IP challenges • enefits of continuous processes in commercial manufacturing and late B • iscussing the rules and regulations that apply specifically D stage product development to the UK ebecca Vangenechten R • sing UK regulations in the evaluation process U Consultant - Business & Project Development Life Sciences, USA Siemens Industry & Automation • P barriers and challenges I 12:00 GMP Critical Utilities from A to Z 16:40 Closing remarks from the chair • esign of pharmaceutical water and steam systems D • uality control during erection Q • ommissioning C • ualification (IQ & OQ) Q • alidation (PQ) V 16:50 Networking drinks • aily operation and sampling D • hange control C Take your discussions further and build new • e-qualification R relationships in a relaxed and informal setting. enrik Goldschmidt H Proceskonsulent GPE Consult Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010
- 4. Day 2 4th Annual Contract Manufacturing Tuesday 14th December 2010 09:00 Registration and refreshments 13:40 CMO management throughout the lifecycle • stablish and improve relationship management practices with E 09:30 Opening address from the chair strategically important CMOs • he process: Plan, select, negotiate, implement and manage T 09:40 Is outsourcing manufacture right for your business? • overnance plan G • efining the strategic direction of the pharma company D • xpected deliverables E • isks and benefits of outsourcing R elson M Lugo N • mpact of outsourcing on marketplace and pharma company I Sr. Director, Contract Manufacturing Amylin Pharmaceuticals • anufacture of commodity products M • anufacture of products using proprietary technologies M 14:20 Achieving product traceability with • ssessing value benefits in cost, time and quality A pharmaceutical packaging artin P Grosvenor M • ost effective and integrated processing for packaging C Drug Delivery Manager • perational challenges in working with 3rd party O AstraZeneca contract manufacturers • ack design/process & reproducibility P 10:20 Contract manufactures: Quality is more than an audit 15:00 Afternoon refreshments • raditional procurement quality T • ustomer: Supplier approach isn’t effective C • elationship management R 15:20 Globalisation in manufacturing: • nderstanding each other U In-house production vs Outsourcing igel Cryer N PANEL DISCUSSION O ur expert panel will discuss and debate on the need for outsourcing, Interim Head, Global Quality Manufacturing & Supply Chain indentifying opportunities and operational challenges to work with third Norgine party contractors P anel members will be drawn from the speakers who take part on day 11:00 Morning refreshments one or day two. I f you would like to submit a question to the panel, please email it to: 11:20 Custom manufacturing: Sourcing APIs in maninder.paul@visiongainglobal.com emerging markets • hat are the commercial implications of increasing globalisation W of the API contract manufacturing market? • PI supplier identification and negotiations A 16:00 Lean product development in a pharma CMO set-up • valuation of the economic, financial and technical needs to drive a lean E • arket evolution: Regulatory compliances, new patent laws, M mentality within product development decreasing number of NCEs • ow to achieve, optimise & continually support an integrated approach for H aurent Pinchard L implementing lean product development? Director – EU Operations (API) Glenmark Generics • eview of case studies as to the benefits realised from both CMOs and R pharmaceutical companies using a lean approach aren MacGregor K 12:00 Emerging markets: CMO outsourcing Product Development Director • nderstanding the influence of global regulatory culture on U Catalent establishing outsourcing projects • ndentifying lucrative opportunities and establishing strategic I 16:40 Chair’s closing remarks alliances in emerging markets to minimise costs • egal and intellectual property challenges in negotiating contracts L and managing relationships 16:50 End of conference 12:40 Networking lunch
- 5. Registration Form 4th Annual Contract Manufacturing 13th - 14th December 2010, London UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code VG 4th Annual Contract C Ci ty Ro Manufacturing ad Standard Prices 13th – 14th December 2010 Old Street Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 Location: SG Conference Centre B Old Street Address: 226-236 City Road London City Road Promotional Literature Distribution EC1V 2TT Distribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £174.83 Total: £1173.83 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/cm Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: 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 made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or Methods of payment after one month before the start of the event. 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VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Signature: Unable to attend Cardholder’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 your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£96.25 Total:£646.25 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/cm