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

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
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11+ case studies
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Preparing for the journey.
Adapt your CTL within the evolving regulatory
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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
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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
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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

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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
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