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SMi Group's Clinical Trial Logistics 2016

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SMi Group's Clinical Trial Logistics 2016 conference and exhibition returns for its 10th year this May in London

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SMi Group's Clinical Trial Logistics 2016

  1. 1. www.clinical-trial-logistics.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 @SMIPHARM #SMICTL KEY BENEFITS FOR 2016: • Gain key regulatory updates from Daiichi Sankyo and MHRA talking specifically on the development of the New EU Clinical Trials Regulation • Discuss how to integrate forecasting and supply planning to an efficient clinical supply chain with GlaxoSmithKline • Norgine presents how they ensure and maintain a successful contractor relationship • Engage in discussions with Sanofi on visibility in the supply chain to fight counterfeiting SMi Presents the 10th Annual Conference and Exhibition on... 18 -19 MAY 2016 Clinical Trial Logistics CHAIR 2016: Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen FEATURED SPEAKERS: • Graham McNaughton, Pharmaceutical Assessor, MHRA • Elisabetta Carli, Head, Operations Clinical Vaccines Management, GlaxoSmithKline • Tony Moult, Director, Clinical Supplies Operations, Daiichi Sankyo • Geoffroy Bessaud, AVP, Anti-Counterfeiting Coordination, Sanofi • Dawn Padfield, Director of Pharmaceutical Development and Clinical Supply, Norgine • Elodie Fontaine, Clinical Trial Lead, Lundbeck • Jasmin Hellwig, Senior Comparator Specialist, Merck Sharp and Dohme • Abdulkareem Ghanayem, Clinical Trial Operations Project Manager, Takeda BOOK BY 29TH FEBRUARY AND SAVE £400 | BOOK BY 31ST MARCH AND SAVE £200 Proudly Sponsored By Holiday Inn Kensington Forum, London, UK 11+ case studies from international pharmaceutical and biotech companies Preparing for the journey. Adapt your CTL within the evolving regulatory landscape for successful compliance
  2. 2. Clinical Trial Logistics Day One | Wednesday 18th May 2016 08.30 Registration & Coffee 09.00 Chairman's Opening Remarks Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen OPENING ADDRESS 09.10 Examining the impact of the new Clinical Trials Regulation (CTR) on industry •An in depth comparison of the new Clinical Trials Regulation to the current Clinical Trial Directive •Assessing the impact of this change to the clinical trial logistic industry •Discussing why you should start preparing for this change now •The benefits of the CTR towards harmonisation throughout the EU •End user perspective on anticipation of future audits Graham McNaughton, Pharmaceutical Assessor, MHRA A CLOSER LOOK AT THE CLINICAL SUPPLY CHAIN 09.50 The importance of forecasting and supply planning in avoiding logistical delays •Integrating and implementing forecasting and planning to ensure supply reaches the location in a timely and safe manner •How to keep supply planning strategies in line with increasingly complex clinical trial designs •A comparison of the different clinical supplies planning systems •The role of statistical forecasting in S&OP Elisabetta Carli, Head, Operations Clinical Vaccines Management, GlaxoSmithKline 10.30 Morning Coffee 11.00 How to ensure and maintain a successful contractor relationship •Implementing due diligence to find the best fit when choosing a vendor •The importance of good communication to get the best out of the relationship •Negotiating and establishing clear agreements to avoid logistical pitfalls •How to retain sufficient control with effective feedback channels and data monitoring as a client Dawn Padfield, Director of Pharmaceutical Development and Clinical Supply, Norgine 11.40 Randomisation and trial supply management (RTSM) or artificial intelligence (AI)? Human vs. machine in the clinical supply chain •Consider the expectations placed on RTSM systems and vendors in today’s clinical trials •Evaluate the risk of those expectations to the clinical supply chain •The role of the mere human – obsolete or pivotal? •What does the future of RTSM hold? Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen 12.20 Networking Lunch 13.50 Challenges of operation for paediatric clinical supply •Investigational Medicinal Products (IMP) – optimizing the supply chain •Challenges involved with material supply •Other challenges not directly related to supplies Elodie Fontaine, Senior Clinical Operations Leader, Lundbeck 14.30 GS1 standards – for improved patient care and supply chain efficiency •Global standards – why are they needed? •GS1 system of standards – Identify, capture and share •Worldwide regulatory developments •The benefit and ROI of global standards Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office 15.10 Afternoon Tea THE ONGOING CHALLENGE OF TEMPERATURE CONTROL 15.40 Challenges in air-freighting time & temperature shipments •What are the potential risk points for air-freight? •How does IATA Ch.17 Regulations improve the handling and risk mitigation of clinical trial shipments? •What has been the impact of GDP for airlines? •How do airlines maximise performance delivery? Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo KEYNOTE PRESENTATION 16.20 Temperature excursion management •Challenges that occur during shipment to sites and during storage at site. •How to manage temperature excursion •IRT as a supportive tool •Predicting the risk Alexandra Tsioni, Manager, Clinical Supply Chain Study Lead, Global Clinical Operations, Teva Israel THE IMPORTANCE OF LABELLING 17.00 EU CTR Annex VI: Labelling of investigational medicinal products (IMPs) •CTR timing with respect to labels on IMPs •Examining the increased complexity of packaging and labelling of investigational medicinal products •Understanding what information must be included on labels •How to deal with this change and what process should be implemented to ease adherence •The current status of the Industry efforts to have Annex VI changed Tony Moult, Director, Clinical Supplies Operations, Daiichi Sankyo 17.40 Chairman’s Closing Remarks and Close of Day One Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen Register online at: www.clinical-trial-logistics.com • Alternatively fa Sponsored by FedEx Express is the world's largest express transportation company, providing fast and reliable delivery to more than 220 countries and territories. FedEx Express uses a global air-and-ground network to speed delivery of time-sensitive shipments, by a definite time and date with a money-back guarantee. For more information visit www.fedex.com/gb Official Media Partners
  3. 3. Clinical Trial Logistics Day Two | Thursday 19th May 2016 08.30 Registration & Coffee 09.00 Chairman's Opening Remarks Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen OPENING ADDRESS 09.10 Update to ICH GCP E6 (R2) •Analysis and understanding the proposed changes •What are the key changes •What are the implications of the changes Amer Alghabban, Vice President GxP Quality Assurance, Compliance & Training, Karyopharm Therapeutics Inc. 09.50 GDP: Gaps discovered and prioritised case study - a risk-based approach to the EU GDP guidelines •The challenges of transporting clinical trials across the globe •Are we doing enough to comply with the regulations? •Identifying the gaps, assessing the risks prioritising corrective actions – case Study Sanjay Nadarajah, Quality Director, Inglasia Pharma Solutions 10.30 Morning Coffee 11.00 Understanding the impact of the EU GDP guidelines •Examining industries approach to GDP in the supply chain •How to effectively adhere to the guidelines •Current supply chain capability – available services, resources and monitoring Amy Shortmann, Consultant, Director, ASC Associates Ltd IMPLEMENTING A STRINGENT CLINICAL TRIAL LOGISTICS STRATEGY 11.40 Visibility in the supply chain to fight counterfeiting •Examining the issue of counterfeiting •How to implement supply chain visibility and security •Traceability requirements worldwide Geoffroy Bessaud, Associate Vice President, Anti-Counterfeiting Coordination, Sanofi 12.20 Networking Lunch 13.50 Panel Discussion: The Falsified Medicine Directive •Challenges faced with complying with the Falsified Medicines Directive •The role of the national medicines verification organisation (NMVO) •Implementation of the the unique identifier Panelists Geoffroy Bessaud, Associate Vice President, Anti-Counterfeiting Coordination, Sanofi Amer Alghabban, Vice President GxP Quality Assurance, Compliance & Training, Karyopharm Therapeutics Inc. Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office SUPPLY CHAIN STRATEGY & EMERGING MARKETS 14.30 Comparators in clinical trials: Effective meets flexible supply chain •How to match supply and demand? Demand planning view •How to match supply and demand? Comparator sourcing activities •Handling comparator related operational challenges Jasmin Hellwig, Senior, Comparator Specialist, Merck Sharp and Dohme 15.10 Afternoon Tea KEYNOTE PRESENTATION 15.40 Implementing a compliant and patient centric clinical supply strategy •Incorporating compliance changes and regulatory updates in to your strategy •Planning a patient centric strategy with a focus on patient shipments •Incorporating patient needs in to the supply chain throughout Rocio Cuadrado, TSOM Leader Clinical Supplies SCP – Studies & Distribution, Sanofi 16.20 Clinical trial supply challenges in the Middle East •Dealing with local customs and cultures •How to deal with multiple regulatory environments •Opportunities and challenges Abdulkareem Ghanayem, Clinical Trial Operations Project Manager, Takeda 17.00 The planning phase: Phase I, biological products •Focus on limited amount of drug, on-going accelerated stability and the impact on the expiry of the drug •Pros and cons when using CMOs and CROs •Ordering of IMP with special requirements to ensure only a limited group of people handling the drug •Shipment requirements including decision to use warehouses or ship directly to sites within 2-8 °C all over the world Lis Hansen, Clinical Trial Supply Coordinator, Genmab A/S 17.40 Chairman’s Closing Remarks and Close of Day Two Rebecca Jackson, IVR/IWR Manager, Randomisation & Trial Supply Services, Janssen Supported by Want to know how you can get involved? Interested in promoting your services to this market? Contact Honey De Gracia, SMi Marketing on +44 (0) 207 827 6102 or email: hdegracia@smi-online.co.uk ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
  4. 4. FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK CLINICAL TRIAL LOGISTICS Conference: Wednesday 18th & Thursday 19th May 2016, Holiday Inn Kensington Forum, London, UK 4 WAYS TO REGISTER www.clinical-trial-logistics.com If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days ofeventrequirepaymentonbooking.AccesstotheDocumentPortalwillnotbegivenuntilpayment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. Unique Reference Number Our Reference LVP-173 Terms and Conditions of Booking DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712 □ Book by 29th February 2016 to receive £400 off the conference price □ Book by 31st March 2016 to receive £200 off the conference price EARLY BIRD DISCOUNT Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-173 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): DOCUMENTATION I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) PAYMENT VAT VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________________ CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total □ Conference only £1499.00 + VAT £1798.80 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference.

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