Clinical Trial Logistics & Supply (2011) Pp


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Clinical Trial Logistics & Supply (2011) Pp

  1. 1. Clinical Trial Logistics & Supply Anticipating and overcoming management and delivery challenges 29th - 30th September 2011, Thistle City Barbican, London, UK BOOK NOW! Key Speakers Vladimir Anisimov, Senior Director, Research Statistics Unit, QSci, GlaxoSmithKline Martin Simán, Clinical Information Science Director, AstraZeneca Uwe Gudat, Medical Director, Office of the Chief Medical Officer, Merck Serono Maria Eugenia Giribets Parra, Clinical Supply Chain Coordinator, Boehringer-Ingelheim Pharma Justin Doel, Clinical Supplies Manager, Novartis Vaccines & Diagnostics, Global Clinical Research & Development Penelope Ward, Senior Director, Experimental Medicine, UCB New Medicines Sean Smith, Vice President, Clinical Supply Chain, Fisher Clinical Services Bassam Hallis, Project Manager, Health Protection Agency Annegret Van der Aa, Clinical Trial Manager, Galápagos Stuart McGuire, Executive Director Global Business Development, Chiltern Angus Cameron, Director & Senior Vice President, Business Development, Pharmarama International Lewis Cameron, Chief Executive Officer, Clearstone LaboratoriesSilver SponsorsAssociate Sponsors Diagnostics Clinical Clinical Pharma Sciences Technologies Services Services Organised By Driving the Industry Forward | www.futurepharmaus.comMedia Partners To Book Call: +44 (0) 20 7336 6100 |
  2. 2. Conference Introduction Clinical Trial Logistics & Supply 29th - 30th September 2011, London, UK Silver Sponsors:Dear Colleague, Incorporated in 1998, DGP Intelsius specializes in the design, utting overheads and improving supply chains in today’s market is as pressing a need as C manufacture and supply of temperature-controlled packaging and ever. With the whole drug development process heavily dependant on clinical trial efficiency, regulatory-compliant sample transport solutions. With a strong focus logistic and supply chain optimisation are now integral to cost saving. on developing environmentally sustainable products and procedures, we offer clients an eco-friendly ffectively transporting clinical trial materials to investigator sites, and patient samples back E way to ensure the integrity of their products. DGP Intelsius has a growing global presence, with manufacturing facilities, distribution hubs and local offices situated throughout the world, including to central laboratories are critical if a product is to be launched on time and within budget. North America, Europe and Asia. We are dedicated to protecting life’s most precious cargo. In a world where time is money, even a week’s delay can potentially cost millions. For further information please visit: oreover, the relentless pressure to bring drugs to market quickly and cheaply means many M Durbin is a global leader in clinical trail supply, specialising in Comparators, Standard of Care studies are now outsourced to Eastern European and other emerging markets. With each medications and Ancillary supplies. Based on its foundations, heritage and experience Durbin country having unique guidelines, understanding the complexities of shipping materials to a brings a difference for the Clinical Trial supply market. This difference – The Durbin Difference – can variety of destinations is crucial. Opportunities for strategic and adaptive planning include: be summarised as 1) Global sourcing capability – frequently sourcing from over 100 countries, regulatory compliance, multi-language labeling, risk-based modelling, and secure, co- 2) Global custom distribution – custom distribution solutions to 180 countries 3) Transparent ordinated distribution. Whichever stage you’re at, maximising value demands an integrated pricing – full disclosure of all purchase costs and invoices. For more information please contact and well organised supply chain. or +44 208 869 6517. Proven reliability. It’s in our DNA. For further information please visit:’s Clinical Trial Logistics and Supply conference addressesyour concerns, enabling you to efficiently resolve challenges at The Haupt Pharma Group is one of the largest, fully integrated contract development and manufacturing organisations in Europe with nine regional, national and international levels. In addition to providing production sites in Germany, France, Italy and Japan. Our services cover the the latest developments in security, forecasting, partnering and complete process chain from lab scale formulation development via process outsourcing, you will also leave empowered to: development and validation tocommercial scale production. A portfolio of standard pharmaceutical • Optimise drug pooling for clinical trial supplies dosage forms is rounded off by lyophilized formulations. In addition to conventional APIs, Haupt • Ensure bioequivalence when undertaking comparative trials Phama handles cytotoxics, hormones and controlled drugs. Our corporate development organisation provides a single customer interface for development, analytics and clinical trial supplies. • Integrate national regulatory requirements into protocol design • Improve patient management for studies conducted in emerging markets For further information please visit: • Label investigational medicinal products country-specifically to meet customs approval Associate Sponsors: • Forecast supply demand to eliminate wastage Sofrigam, cold chain expert. Rely on Sofrigam’s expertise, packaging and services • Optimise sample management to warranty your cold chain security. Sofrigam designs and qualifies isothermal • mplement a secure cold chain strategy and reduce temperature deviation and delivery I and refrigerated packaging enabling the transport of heat sensitive products (fresh time during shipping or frozen) in non-refrigerated vehicles. The materials used associated with the expertise of our engineers and our partnership with Ater Metrologie Laboratory, means our products are suitable for sectors that are • valuate improved GPS and RFID temperature-monitoring devices to minimize risk during E VERY demanding with regard to quality and safety, such as the pharmaceutical, chemical, biotechnology transportation industries. We offer our clients a range of standard or made-to-measure products and services enabling • Maximise your depot supply and distribution practices them to establish secure, economical and ecological cold chain logistics. • Implement lessons gleaned from case studies from Eastern Europe, the Far East and Asia For further information please visit: • Utilise IVR and IWR to save time and money Based in France, Euromedex is an experienced partner for CROs and promoters I look forward to meeting you at the conference involved in clinical trials. Euromedex organizes and follows all the logistics of Best regards clinical trials, from manufacturing to delivery of the drug to the investigators. Services provided are in strict compliance to laws and regulatory; Euromedex has a Quality Assurance System allowing to fulfill most demanding pharmaceutical requirements and especially GMP/GDP. Euromedex offers services of a logistic centre and a central pharmacy for all logistic operations : reception, checking, storage and delivery under different temperature conditions. We propose short delivery time to John Shah the sites (for France in one day).Goods flows are traced and follow up is available. Senior Conference Producer For further information please visit: Almac Clinical Services, part of the Almac Group, has over 20 years experience delivering a full range of global clinical trial supply and innovative technology solutions Clinical Clinical Pharma Diagnostics Sciences to Pharmaceutical and Biotech Companies worldwide. We are the most trusted and Technologies Services Services Who should attend? stable name in the clinical supply marketplace. We are differentiated by our exceptional client service powered Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific by experienced and knowledge based Project Management. Our clinical supply services include: Global Officers, Directors, Principal Scientists, Franchise Heads and Investigators in: comparator sourcing, Blinding and over-encapsulation, Packaging and labelling of trial supplies, Online Label • Clinical Research Approval System, Global distribution and depot network ,Shipping Temperature Monitoring (STEMS), Project • Clinical Operations Management and Qualified Person consulting, range of analytical services and drug supply management. • Clinical Logistics Planning/Distribution For further information please visit: • Clinical Trial Process Implementation • Drug Formulation Media Partners: • Chemistry, Manufacturing & Controls is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical • Drug Supply Planning/Management corporations, provides dynamic real-time news, features, • Clinical Trial Support events listings and international jobs to industry professionals across Europe and the US. • Global Clinical Outsourcing For further information please email: • Clinical Packaging BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and • Labelling located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide • Supply Chain Management/Integrity the world’s biotech and pharma information and market to make it universally • Cold Chain Technology accessible and useful for scientific and business processes. Its first step to fulfilling that mission was • Transportation Operations building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different • Business Development channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and • Quality Assurance Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. • Research Statistics • Regulatory Affairs For further information please visit: Future Pharmaceuticals has forged powerful relationships with key Driving the Industry Forward | industry leaders to provide a platform for successful brand 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 authoritative resource Sponsorship and exhibition opportunities within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals This event offers a unique opportunity to meet and do business with some of the key magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: For further information please visit: InPharm is the online platform for exclusive pharmaceutical news, • Hosting a networking drinks reception comment, contracts, services, jobs and events and is home to InPharmjobs.• Taking an exhibition space at the conference com, Pharmafile and Pharmafocus. • Advertising in the delegate documentation pack For further information please visit:• Providing branded bags, pens, gifts, etc. Welcome to Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical If you would like more information on the range of sponsorship or exhibition possibilities and biopharmaceutical contract services. With regular sections on contract for visiongains Clinical Trial Logistics & Supply Conference, please contact us: manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most Damian Gorman, +44 (0)20 7549 9934 complete coverage of trends and issues in the industry to our 15,000 readers in North For further information please visit:
  3. 3. Day 1 Clinical Trial Logistics & Supply Thursday 29th September 2011 09:00 Registration and refreshments 13:40 Predictive drug supply modelling in clinical trials (statistical methodology and software) • ain uncertainties and risks in CT supply chain processes M 09:30 Opening address from the Chair • redictive patient recruitment and risk-based supply modelling tools P • Software tools for drug supply modelling 09:40 Designing a clinical programme Vladimir Anisimov • Understanding corporate and clinical research goals Senior Director, Research Statistics Unit, QSci • Planning and implementing a suitable programme GlaxoSmithKline • Case study examples 14:20 Presentation to be announced Uwe Gudat Medical Director, Office of the Chief Medical Officer Robert Donnell Merck Serono Business Development Manager Durbin 14:40 Bioequivalence and strategic comparator sourcing 10:20 Coordinating complex clinical information flow phase III • Benefits of a single comparator for a worldwide trial • Aligning clinical information from multiple CROs and big pharma • Bioequivalence: if it walks like a duck and quacks like a duck… CASE STUDY • Managing challenges to evolve into success • FDA Waivers Angus Cameron • Lessons learned from an alliance phase III development programme Director and Senior Vice President Martin Simán Pharmarama International Clinical Information Science Director AstraZeneca 15:20 Afternoon refreshments 15:40 Drug pooling as a clinical supply strategy 11:00 Morning refreshments • Definition and regulatory background of drug pooling • Possible drug pooling approaches, benefits and challenges 11:20 Quality considerations for audit compliance • Case study: pooling at sites across studies • verseeing trial progress and ensuring it meets GCP guidelines and O Maria Eugenia Giribets Parra sponsor SOPs Clinical Supply Chain Coordinator • he roles of the sponsor of a clinical investigation, the IRB, or T Boehringer-Ingelheim Pharma independent ethics committee • he roles and responsibilities of the clinical trial investigator T 16:20 Assay development and sample management • Sample handling 12:00 Strategic considerations for patient recruitment, • Sample logging and tracking through the analysis cycle retention and compliance in multinational trials • Reducing uncertainty through quality assurance • Recruitment practices across cultures; the good, the bad and the ugly Bassam Hallis Project Manager • Minimising drop out; enhancing patient retention Health Protection Agency • Violations and deviations; strategies to improve compliance Penelope Ward 17:00 Closing remarks from the Chair Senior Director, Experimental Medicine UCB New Medicines 17:10 Networking drinks 12:40 Networking lunch 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
  4. 4. Day 2 Clinical Trial Logistics & Supply Friday 30th September 201109:00 Registration and refreshments 13:40 Management and supply challenges in09:30 Opening address from the Chair emerging markets PANEL DISCUSSION Justin Doel O ptimising procurement, distribution and third-party deliveries are among Clinical Supplies Manager the many challenges encountered when running trials in BRICK and EEU Novartis Vaccines & Diagnostics, Global Clinical countries. Panelists will discuss strategies to overcome these and other Research & Development hurdles, as well as complying with regulatory, QA standards and labelling guidelines, choosing and supplying investigator sites, and meeting national inspection standards. Selecting the right transport strategy and realistic 09:40 Personalised medicine – it’s always about YOU, isn’t it? timelines for obtaining import licenses will also be considered. Please • Importance of stratification email your questions for the panel to • Impact on clinical trials Chair: Angus Cameron, Director and Senior Vice President, Pharmarama International • A glimpse of the future Annegret Van der Aa, Clinical Trial Manager, Angus Cameron Development, Galápagos Director and Senior Vice President Pharmarama International Stuart McGuire, Executive Director Global Business Development, Chiltern10:20 Customs requirements in Eastern Europe Lewis Cameron, Chief Executive Officer, Clearstone • Setting quality agreements Laboratories • Deciding contractual partners Robert Donnell, Business Development Manager, Durbin • Essential GMP/GDP contents 14:20 Managing time and temperature sensitive11:00 Morning refreshments supply chains • Planning in advance: from depot to site • Understanding local distribution infrastructure11:20 Essential steps towards successful clinical trial • Customs and regulatory compliance supplies in Eastern European countries - case study Sean Smith • Rationale for conducting studies in EEU countries Vice President, Clinical Supply Chain CASE STUDY Fisher Clinical Services • Additional regulatory challenges in EEU countries • Case study: real-life experience & lessons learned 15:00 Afternoon refreshments Annegret Van der Aa Clinical Trial Manager, Development 15:20 Piloting RF-enabled technology for temperature Galápagos monitoring in clinical trails • Potential of RF enabled technology for temperature monitoring • Piloting experience (setup, conduct, data analysis)12:00 Presentation to be announced • onsiderations when implementing RF-technology for C • dentifying the right transport strategy for your clinical trial I temperature monitoring with focus on central lab • Managing risks on clinical trial sample transportation 16:00 Minimising risk in CASE STUDY • Rightsizing your batch shipment frequency low-temperature maintenance Stuart McGuire • Ensuring integrity of packaging containers Executive Director Global Business Development • Risk assessment techniques in the supply chain Chiltern • Integrated feedback processes Lewis Cameron Chief Executive Officer Clearstone Laboratories 16:40 Chair’s closing remarks12:40 Networking lunch 16:50 End of conference
  5. 5. Registration Form Clinical Trial Logistics & Supply 29th - 30th September 2011, London, UK Conf. code PP Clinical Trial LogisticsStandard Prices & SupplyConference only Fee: £1299 VAT: £259.80 Total: £1558.80 29th - 30th September 2011Number of bookings: Total cost: Location: Thistle City Barbican Address: Central Street, ClerkenwellPromotional Literature Distribution London Distribution of your company’s promotional literature to all conference attendees EC1V 8DS UK Fee: £999 VAT: £199.80 Total: £1198.80Details How to bookForename: Surname: Email: Web: Job Title: Company: UK Office: Tel: +44(0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd BSG HouseAddress: 226-236 City Road London EC1V 2QY UKCountry: Postcode: General information Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / Phone: Fax: +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 Guests should quote the booking reference number VISW290911_006 by 15/09/2011 when making Email: their booking in order to guarantee they receive the group rate. UK Telephone Number: 0871 977 0218, International Telephone Number: +44845 073 7154, E-mailing: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may I confirm that I have read and agree to the terms and conditions of booking be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices.Methods of payment 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 Payment must be made in sterling after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places By Mail: Complete and return your signed registration form together with your cheque payable between conferences. However, if you cannot attend the conference, you may make a substitution/name to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organisation and are not transferable between By Fax: Complete and fax your signed registration form with your credit card details countries. Please note that discounted delegates places at a visiongain event are non +44 (0) 20 7549 9932 Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details customer by credit card prior to the changes being made.By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Bank Transfer: due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or Visiongain Ltd A/C: visiongain Ltd expenses, which may be incurred by the customer as a consequence of the event being postponed or 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 London, W1B 5RA IBAN: GB80 BARC 20716460387118 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you Please debit my credit card: wish for your details to be amended, suppressed or not passed on to any external third party, please 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 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, 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.Cardholder’s name: Unable to attend 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