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"A good range of talents are being brought together to really look at the supply chain from different angles" Helen Underwood, Global Clinical Supplies Operations, Merck

"Very informative and covers a broad range of topics" Karen Raimondi, Clinical Supplies Logistics Manager, Procter & Gamble Pharmaceuticals

Many companies are still using a one-size-fits-all approach for their clinical trials supply chain and worrying about the dangers of contamination and counterfeiting when transporting clinical trials materials. Not only do you have to face these concerns head on but since clinical trials are getting larger, more complex, reaching to the farther edges of the globe and, more importantly, the timeframes involved are shrinking effective supply chain management is becoming much tougher! Are you prepared to face and deal with these critical issues?


SMi’s Clinical Trials Logistics conference will address your concerns in implementing complex procedures for transporting sensitive materials under the latest global challenges. Through a series of presentations learn from key industry personnel that have found and implemented effective solutions and are leading the way forward.

Our exceptional speaker line-up includes special presentations by:

  • Aaron Graham, Vice President Corporate Security, Purdue Pharma
  • David Brennan, Assistant Director, Special Cargo Standards, International Air Transport Association
  • Tony Street, Clinical Trials Supply, Allergan
  • Kunal Jaiswal, Associate Director, Clinical Supplies, Schering Plough

Case Studies from industry leaders such as: 

  • Dr Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline
  • Dr Brian B. O’Neill, Global Head CQA External Alliances, F. Hoffmann-La Roche
  • Charlotte Mackeprang, Associate Director, Manufacturing, Genmab

Exclusive presentations from industry experts:

  • Marc Voigt, Member of the Management Board, Medical Enzymes
  • Dr. Frans Maris, Executive Director, Investigational Product Supply, NV Organon
  • Claude Ammann, Director, QA & Quality Control, APOXIS
  • David Mooney, Global Director, Materials and Logistics, Quest Diagnostics Clinical Trials
  • Jan Murray, Partner, Squire, Sanders & Dempsey LLP
  • Cristiana Spontoni, Partner, Squire, Sanders & Dempsey LLP
  • Alfred Mottram, Associate Director, Materials Management, MEDAREX
  • Bernard Auton, Director, Inova Group & The Chartered Institute of Logistics and Transport
  • Peter Laurence, Director, SCB Consulting
  • Paul Ranson, Member, Stringer Saul LLP

Chaired by:

Dr Umit Kartoglu, Scientist, Department Of Immunization, Vaccines & Biologicals, World Health Organization

Critical challenges that will be addressed…

  • The implications of the shift of activity from to the Far East and Eastern Europe
  • The challenges in meeting the latest regulatory requirements
  • Ensuring security in an increasingly diverse supply chain
  • Gain a fresh insight into tracking technologies such as RFID mandates and their implementations
  • Evaluate outsourcing models and In-house logistics practices
  • Managing the (cold) chain distribution and logistics


This is a must attend event for all those working in the market!

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Umit Kartoglu

Umit Kartoglu, Scientist, Department of Immunization, Vaccines and Biologicals, World Health Organization

9:10 BUILDING A FOUNDATION FOR CAPACITY BALANCING IN CLINICAL SUPPLY VALUE CHAIN

Kunal Jaiswal

Kunal Jaiswal , Associate Director, Clinical Supplies, Schering Plough

  • Establishing business rules to characterize capicity
  • Establishing business rules to characterize workload
  • Balancing orkload through cross functional governance
  • 9:50 LEARNING’S FROM THE COMMERCIAL SUPPLY CHAIN

    Dr Peter Laurence

    Dr Peter Laurence, Director, scb consulting

  •  Converting the commercial supply chain to clinical trials supply
  •  Whatcan we learn?
  •  Areas for improvement
  • 10:30 Morning Coffee

    11:00 REGULATION OF CLINICAL TRIALS IN THE EU & US

  • Overview of clinical trial regulation in US an EU
  • Common regulatory ground: ICH guidance
  •  Differences in regulation: 
  • Differences in requirements

    Differences in process (FDA versus Member States)

  • Implications for US or EU companies conducting trials outside their home jurisdictions
  • Jan Murray

    Jan Murray, Partner, Squire Sanders & Dempsey L L P

    Cristiana Spontoni

    Cristiana Spontoni , Partner, Squire Sanders & Dempsey LLP

    11:40 CHANGES IN THE IATA REGULATIONS

  •  Packaging
  • Paperwork
  •  Declaration
  • Legal implications
  • Training

  • David Brennan

    David Brennan, Assistant Director, International Air Transport Associaton

    Geoff  Leach

    Geoff Leach, Head, Dangerous Goods Office , Civil Aviation Authority

    12:20 Networking Lunch

    13:50 SUPPLY CHAIN SECURITY

    Aaron Graham

    Aaron Graham, Vice President Corporate Security, Purdue Pharma

  • Theft, fraud and counterfeit drugs
  • Emerging technologies
  • Problems and solutions
  • Where do the responsibilities lie?
  • Working with regulatory agencies
  • 14:30 IS THIS THE BUSINESS CASE FOR RFID?

    Bernard Auton

    Bernard Auton, Director of Business Development, Inova Management

  • What is needed in a comprehensive Business Case?
  • Where have other RFID users found costs and savings?
  • Does the Pharmaceutical Sector have special needs?
  • What is driving RFID in the Pharmaceutical Sector?
  • How is RFID being used in clinical trials?
  • 15:10 Afternoon Tea

    15:40 PATIENT RECRUITMENT PREDICTION

  • Probabilistic models of enrolment
  • Model fitting and prediction
  • Waiting time to enrol
  • Minimizing risk function – adaptive adjustment of enrolment
  • Examples
  • Dr Valeri Fedorov

    Dr Valeri Fedorov, Group Director, Research Statistics Unit, GlaxoSmithKline

    Dr Vladimir  Anisimov

    Dr Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline

    Vladimir  Anisimov

    Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline

    16:20 CASE STUDY

    Charlotte Mackeprang

    Charlotte Mackeprang, Associate Director, Manufacturing, Genmab

  • Managing logistics issues
  • Tracking materials
  • Maintaining costs
  • Issues and solutions
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    Umit Kartoglu

    Umit Kartoglu, Scientist, Department of Immunization, Vaccines and Biologicals, World Health Organization

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Umit Kartoglu

    Umit Kartoglu, Scientist, Department of Immunization, Vaccines and Biologicals, World Health Organization

    9:10 DEVELOPING AND NEGOTIATING OUTSOURCING AGREEMENTS

    Paul Ranson

    Paul Ranson, Member, Stringer Saul Solicitors

  • Outsourcing Agreements
  • Pre –contractual considerations
  • Key terms and outsourcing agreements
  • Resolving disputes
  • 9:50 MANAGING CLINICAL TRIALS FOR BIOTECHS

    Marc Voigt

    Marc Voigt, Member of the Management Board, Medical Enzymes AG

  • Typical environment for biotech companies
  • Planning clinical trials
  • Make or buy?
  • Managing the partnerships
  • Case studies
  • 10:30 Morning Coffee

    11:00 WORKING WITH INVESTIGATORS AND THIRD PARTY SUPPLIERS - THE PHARMA PERSPECTIVE

    Brian O'Neill

    Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche

  • Appropriate Monitoring procedures
  • Improving efficiency in quality management of external service providers
  • 11:40 OPTIMIZATION IN CLINICAL TRIALS PLANNING

    David Mooney

    David Mooney, Global Director, Material Logistics, Quest Diagnostics Clinical Trials

    Vladimir Shnaydman

    Vladimir Shnaydman, President, ORBee Consulting

    12:20 Networking Lunch

    14:30 COLD CHAIN DISTRIBUTION AND LOGISTICS

    Alfred L. Mottram III

    Alfred L. Mottram III, Associate Director, Materials Management, Medarex

  • Issue when dry ice is too cold
  • Pre-engineered solution and gap
  • Modified solution and operational testing
  • Performance during actual shipment from US to Brazil
  • 15:10 Afternoon Tea

    15:40 MANAGING THE (COLD) CHAIN DISTRIBUTION AND LOGISTICS

  • Practical solutions to overcome temperature deviation problems
  • Identifying and overcoming issues relating to distribution and storage of cold chain products
  • Ensuring validation throughout the (cold-)chain
  • Qualification of the shipper and temperature logger
  • Key performance indicators for (cold-) chain supply
  • Dealing with temperature excursions
  • Frans Maris

    Frans Maris, Executive Director, NV Organon

    Werner Stolle

    Werner Stolle, Manager Logistic Services IMPs, Organon

    16:20 CLINICAL SUPPLY CHAIN AND IVRS

    Tony Streets

    Tony Streets, Manager, European Clinical Supply, Allergan

  • IVRS Basics - Why is IVRS so popular?
  • Central vs regional block balancing
  • IVRS in open label studies
  • Electronic Expiry dates versus printed expiry dates
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    Umit Kartoglu

    Umit Kartoglu, Scientist, Department of Immunization, Vaccines and Biologicals, World Health Organization

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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