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www.clinical-trial-logistics.comRegister 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 - 19MAY2016
Clinical TrialLogistics
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 internationalpharmaceutical
and biotechcompanies
Preparing for the journey. Adapt your CTL within the evolving regulatorylandscape for successful compliance
Clinical Trial LogisticsDay One | Wednesday 18th May 2016
08.30 Registration & Coffee
09.00 Chairman's Opening RemarksRebecca Jackson, IVR/IWR Manager, Randomisation & TrialSupply 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 inavoiding 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 withincreasingly complex clinical trial designs
•A comparison of the different clinical supplies planningsystems
•The role of statistical forecasting in S&OP Elisabetta Carli, Head, Operations Clinical VaccinesManagement, GlaxoSmithKline
10.30 Morning Coffee
11.00 How to ensure and maintain a successful contractorrelationship •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 Developmentand Clinical Supply, Norgine
11.40 Randomisation and trial supply management (RTSM) orartificial intelligence (AI)? Human vs. machine in the clinicalsupply 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 & TrialSupply 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 suppliesElodie Fontaine, Senior Clinical Operations Leader, Lundbeck
14.30 GS1 standards – for improved patient care and supply chainefficiency•Global standards – why are they needed?•GS1 system of standards – Identify, capture and share•Worldwide regulatory developments•The benefit and ROI of global standardsUlrike 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 & LifeSciences, IAG Cargo
KEYNOTE PRESENTATION 16.20 Temperature excursion management
•Challenges that occur during shipment to sites and duringstorage at site.
•How to manage temperature excursion •IRT as a supportive tool•Predicting the riskAlexandra Tsioni, Manager, Clinical Supply Chain StudyLead, Global Clinical Operations, Teva Israel
THE IMPORTANCE OF LABELLING
17.00 EU CTR Annex VI: Labelling of investigational medicinalproducts (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
changedTony Moult, Director, Clinical Supplies Operations, Daiichi Sankyo
17.40 Chairman’s Closing Remarks and Close of Day OneRebecca Jackson, IVR/IWR Manager, Randomisation & TrialSupply Services, Janssen
Register online at: www.clinical-trial-logistics.com • Alternatively fa
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Clinical Trial LogisticsDay 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 identifierPanelistsGeoffroy Bessaud, Associate Vice President, Anti-Counterfeiting Coordination, SanofiAmer 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 supplychain•How to match supply and demand? Demand planning view•How to match supply and demand? Comparator sourcing
activities•Handling comparator related operational challengesJasmin Hellwig, Senior, Comparator Specialist, Merck Sharpand 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
throughoutRocio 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 challengesAbdulkareem Ghanayem, Clinical Trial Operations ProjectManager, 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 theworld
Lis Hansen, Clinical Trial Supply Coordinator, Genmab A/S
17.40 Chairman’s Closing Remarks and Close of Day TwoRebecca Jackson, IVR/IWR Manager, Randomisation & TrialSupply 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
FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, 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 REGISTERwww.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
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