www.clinical-trial-logistics.comRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 @SMIPHARM

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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

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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

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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

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CLINICAL TRIAL LOGISTICS Conference: Wednesday 18th & Thursday 19th May 2016, Holiday Inn Kensington Forum, London, UK

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