Clinical Trial Logistics & Supply

Transcription

1 Driving the Industry Forward Clinical Trial Logistics & Supply Anticipating and overcoming management and delivery challenges 29th - 30th September 2011, Visiongain Conference Centre, 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 Gary Cunnington, Global Head of Clinical Trial Supplies Respiratory, Boehringer-Ingelheim Georgi Georgiev, Clinical Research Manager, Head of Office, Bulgaria, AstraZeneca 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 Sascha Holzmann, Manager, Clinical Logistics Services, PAREXEL International Stuart McGuire, Executive Director Global Business Development, Chiltern Angus Cameron, Director & Senior Vice President, Business Development, Pharma International Lewis Cameron, Chief Executive Officer, Clearstone Laboratory Media Partners Organised By To Book Call: +44 (0)

2 Driving the Industry Forward Conference Introduction 29th - 30th September 2011, London, UK Dear Colleague, Cutting overheads and improving supply chains in today s market is as pressing a need as ever. With the whole drug development process heavily dependant on clinical trial efficiency, logistic and supply chain optimisation are now integral to cost saving. Effectively transporting clinical trial materials to investigator sites, and patient samples back to central laboratories are critical if a product is to be launched on time and within budget. In a world where time is money, even a week s delay can potentially cost millions. Moreover, the relentless pressure to bring drugs to market quickly and cheaply means many studies are now outsourced to Eastern European and other emerging markets. With each country having unique guidelines, understanding the complexities of shipping materials to a variety of destinations is crucial. Opportunities for strategic and adaptive planning include: regulatory compliance, multi-language labeling, risk-based modelling, and secure, coordinated distribution. Whichever stage you re at, maximising value demands an integrated and well organised supply chain. Visiongain s Clinical Trial Logistics and Supply conference addresses your concerns, enabling you to efficiently resolve challenges at regional, national and international levels. In addition to providing the latest developments in security, forecasting, partnering and outsourcing, you will also leave empowered to: Optimise drug pooling for clinical trial supplies Ensure bioequivalence when undertaking comparative trials Integrate national regulatory requirements into protocol design Improve patient management for studies conducted in emerging markets Label investigational medicinal products country-specifically to meet customs approval Forecast supply demand to eliminate wastage Optimise sample management Implement a secure cold chain strategy and reduce temperature deviation and delivery time during shipping Evaluate improved GPS and RFID temperature-monitoring devices to minimize risk during transportation Maximise your depot supply and distribution practices Implement lessons gleaned from case studies from Eastern Europe, the Far East and Asia Utilise IVR and IWR to save time and money I look forward to meeting you at the conference Best regards John Shah Senior Conference Producer Who should attend? Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific Officers, Directors, Principal Scientists, Franchise Heads and Investigators in: Clinical Research Clinical Operations Clinical Logistics Planning/Distribution Clinical Trial Process Implementation Drug Formulation Chemistry, Manufacturing & Controls Drug Supply Planning/Management Clinical Trial Support Global Clinical Outsourcing Clinical Packaging Labelling Supply Chain Management/Integrity Cold Chain Technology Transportation Operations Business Development Quality Assurance Research Statistics Regulatory Affairs Media Partners: PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please corporate@pharmiweb.com BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. 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 to make it universally accessible and useful for scientific and business processes. Its first 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 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 in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit: Future Pharmaceuticals has forged powerful relationships with key 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 within top 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 gap between the industries top issues and the solutions top-tier vendors can provide. For further information please visit: 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: 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 Clinical Trial Logistics & Supply meeting by sharing your results in a poster presentation. With a plethora of key decision makers, take advantage of this senior networking opportunity. Please send your 200 word abstract, in English, to: info@visiongainglobal.com for approval. The deadline for submissions is Thursday 22nd September, Please include contact details for the corresponding author(s). Academic institutions will not be charged a fee if booked as full-price delegates. Posters submitted by pharmaceutical and biotechnology firms will be charged a fee of 199. Posters submitted by service providers / vendors are welcome and will be subject to evaluation. Upon approval a fee of 500 will apply. Two delegates from your organisation must be booked at full price to present a poster. Please note that all posters will be displayed at the discretion of Visiongain Ltd and are subject to approval. Due to limited space, please register your interest early. Sponsorship and exhibition opportunities This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: Hosting a networking drinks reception Taking an exhibition space at the conference Advertising in the delegate documentation pack Providing branded bags, pens, gifts, etc. If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's Conference, please contact us: Ronald Magali, +44 (0) ronald.magali@visiongainglobal.com

3 Day 1 Thursday 29th September :00 Registration and refreshments 09:30 Opening address from the Chair 09:40 Designing a clinical programme Understanding corporate and clinical research goals Planning and implementing a suitable programme Case study examples Uwe Gudat Medical Director, Office of the Chief Medical Officer Merck Serono 10:20 Coordinating complex clinical information flow phase III Aligning clinical information from multiple CROs and big pharma Managing challenges to evolve into success Lessons learned from an alliance phase III development programme Martin Simán Clinical Information Science Director AstraZeneca 11:00 Morning refreshments 11:20 Quality considerations for audit compliance Overseeing trial progress and ensuring it meets GCP guidelines and sponsor SOPs The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator Lesley Chaplin Consultant LC Biotech 13:40 Predictive drug supply modelling in clinical trials (statistical methodology and software) Main uncertainties and risks in CT supply chain processes Predictive patient recruitment and risk-based supply modelling tools Software tools for drug supply modelling Vladimir Anisimov Senior Director, Research Statistics Unit, QSci GlaxoSmithKline 14:20 Bioequivalence and strategic comparator sourcing Bioequivalence is the key and how to perform such studies Changing regulatory requirements and the BioPharmaceutics Classification System Working with the FDA, and drug costs in the US vs. EU Angus Cameron Director and Senior Vice President Pharmarama 15:00 Afternoon refreshments 15:20 Drug pooling as a clinical supply strategy Gary Cunnington Global Head of Clinical Trial Supplies Respiratory Boehringer-Ingelheim 16:00 Assay development and sample management Sample handling Sample logging and tracking through the analysis cycle Reducing uncertainty through quality assurance Bassam Hallis Project Manager Health Protection Agency 16:40 Closing remarks from the Chair 12:00 Strategic considerations for patient recruitment, retention and compliance in multinational trials Recruitment practices across cultures; the good, the bad and the ugly Minimizing drop out; enhancing patient retention Violations and deviations; strategies to improve compliance Penelope Ward Senior Director, Experimental Medicine UCB New Medicines 16:50 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting. 12:40 Networking lunch 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 Day 2 Friday 30th September :00 Registration and refreshments 09:30 Opening address from the Chair Justin Doel Clinical Supplies Manager Novartis Vaccines & Diagnostics, Global Clinical Research & Development 09:40 Customs requirements in Eastern Europe Setting quality agreements Deciding contractual partners Essential GMP/GDP contents Georgi Georgiev Clinical Research Manager, Head of Office, Bulgaria AstraZeneca 10:20 Essential steps towards successful clinical trial supplies in Eastern European countries - case study Rationale for conducting studies in EEU countries Additional regulatory challenges in EEU countries Case study: real-life experience & lessons learned Annegret Van der Aa Clinical Trial Manager, Development Galapagos 11:00 Morning refreshments 11:20 Presentation to be announced Stuart McGuire Executive Director Global Business Development Chiltern Lewis Cameron Chief Executive Officer Clearstone Laboratory 12:40 Networking lunch 13:40 Managing time and temperature sensitive supply chains Planning in advance: from depot to site Understanding local distribution infrastructure Customs and regulatory compliance Sean Smith Vice President, Clinical Supply Chain Fisher Clinical Services 14:20 Monitoring a drug s environment through the supply chain using RFID Potential of RF enabled technology for temperature monitoring Piloting experience (setup, conduct, data analysis) Considerations when implementing RF-technology for temperature monitoring Sascha Holzmann Manager, Clinical Logistics Services PAREXEL International 15:00 Afternoon refreshments 15:20 Minimising risk in low-temperature maintenance Ensuring integrity of packaging containers Risk assessment techniques in the supply chain Integrated feedback processes 16:00 Challenging the cold chain with distribution to rural and remote locations Transportation hurdles for vaccines to rural and remote locations 12:00 Panel discussion: Supply challenges in emerging markets Panelists will discuss strategies to optimize management and distribution, and co-ordinating delivery with third parties. Ensuring accurate multilanguage labelling, and meeting national inspection, regulatory and QA standards will also be covered. Please your questions for the panel to john.shah@visiongainglobal.com. Stuart McGuire Executive Director Global Business Development Chiltern Lewis Cameron Chief Executive Officer Clearstone Laboratory Harmonizing guidance for storage and transport of temperaturesensitive biologics An international guide to good practice 16:40 Chair s closing remarks 16:50 End of conference

5 Registration Form 29th - 30th September 2011, London, UK Conf. code FB Standard Prices Conference only Fee: 1299 VAT: Total: Number of bookings: Total cost: Promotional Literature Distribution Distribution of your company s promotional literature to all conference attendees Fee: 999 VAT: Total: Clinical Trial Logistics & Supply 29th - 30th September 2011 Location: Visiongain Conference Centre Address: 230 City Road London EC1V 2TT UK Angel Pentonville Road City Road Old Street City Road Old Street Details Forename: Surname: Job Title: Company: Main Switchboard Number: Address: Country: Postcode: Phone: Fax: Signature: I confirm that I have read and agree to the terms and conditions of booking Methods of payment Payment must be made in sterling By Mail: Complete and return your signed registration form together with your cheque payable to Visiongain Ltd and send to: visiongain Ltd, BSG House, City Road, London, EC1V 2QY, UK By Fax: Complete and fax your signed registration form with your credit card details to +44 (0) By Phone: Call us on +44 (0) with your credit card details By Credit Card: Fill in your card details below and fax back to +44 (0) By Bank Transfer: Visiongain Ltd A/C: visiongain Ltd Barclays Bank Sort Code: Piccadilly Branch Account No: Regent Street Swift Code: BARC GB22 London, W1B 5RA IBAN: GB80 BARC Please debit my credit card: Access MasterCard Visa American Express Card number: Expiry Date: Security number (last 3 digits on back of credit card): Signature: Cardholder s name: News updates Please tick if you do not want to receive news updates in the future How to book conferences@visiongainglobal.com Web: UK Office: Tel: +44(0) Fax: +44(0) Visiongain Ltd BSG House City Road London EC1V 2QY UK General information Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: / , Fax: / Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: , Fax: , 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 be requested if payment has not been received in full before the event. Visiongain Ltd reserves the 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, 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 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 change at any time, as long as we are informed in writing by , fax or post. Name changes and 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. 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 customer by credit card prior to the changes being made. 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 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 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 cost of the registration, travel and expenses. Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Protection Act Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or , unless you state otherwise. We 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 send your request to the Database Manager, visiongain Ltd, BSG House, City Road, London, 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. 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). 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) , eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. How we will contact you: Visiongain Ltd s preferred method of communication is by and phone. Please ensure that you complete the registration form in full so that we can contact you. 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. Yes, please send me speaker talks Price 550 VAT: 110 Total: 660