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Clinical Trial Logistics

 

The conference...

It currently costs just over £500 million ($800 million) to bring a new chemical to market and development timelines continue to fall in the 10-15 year range.  A key reason for high R&D costs is due to logistical failures including failure to recruit patients on time. A way to avoid this is to move clinical trials to emerging markets such as Asia, India and Central and Eastern Europe. However by moving clinical trials to these regions other logistical problems emerge such as regulation, customs, poor infrastructure etc.

This conference will provide an update on logistical issues in traditional markets, such as Western Europe and North America as well as providing a focused update on the experiences of pharma companies that are moving their operations to emerging markets.

Key topics at the 2011 conference will include:

  • Forecasting and Planning
  • Challenges of a Globalised Trial Industry
  • The Element of Risk
  • Special Cases: Biologicals, Temperature Control and Adaptive Trials
  • Staffing and Training
  • Successfully managing pharma-CRO partnerships to expedite logistical operations

 

Keen to see the detailed programme?  Click here.

Register for the event here!

 

Fancy speaking at the conference?  Do you know of anyone who may be interested in speaking?  We are always on the look-out for new speakers for our upcoming conferences.  Let us know - contact the Conference Producer.

For sponsorship and exhibitioning opportunities, contact our Sponsorship Department.


SMi is pleased to announce:

Clinical Trial Logistics Asia
18th and 19th July 2011, Singapore

To register your interest in attending, speaking, sponsoring, workshop hosting or shaping the agenda, please click here.

 


Gold Sponsor

 

2011 attendees currently include...

  • ADAllen Pharma Limited
  • Aerotrim Group Ltd
  • Allergan Ltd
  • B & C Group s.a
  • Bayer Schering Pharma
  • Biocair
  • Biocair International Ltd
  • Biogen Idec
  • Celgene
  • Consortium for Biological and Pharmacological Evaluations (CVBF)
  • Creapham Europe
  • ELPRO UK
  • Ferring Pharmaceuticals A/S
  • Hilton Pharma (Pvt) ltd
  • IDDI SA
  • IMP Logistics
  • in2phase Ltd
  • Infarmed – Instituto Naciuonal Da Famacia E Do Medicamento
  • Marken Ltd.
  • Medicore Group
  • Medidata
  • MedImmune
  • Mundipharma Research
  • Napp Pharmaceuticals Limited
  • Novo Nordisk A / S
  • Perrigo
  • Pfizer
  • Pfizer France
  • S G S Life Science Services
  • Sensitech EMEA
  • UCB
  • United Drug plc

 Why should you attend this event?

How you will benefit

  • Identify inefficiencies in your supply chain and develop strategies to remedy them
  • Understand the legislative requirements around clinical trial logistics
  • Learn from and network with senior figures in this area
  • Improve your labeling and packaging procedures
  • Understand the intricacies of performing clinical trials in emerging markets
 patient retention

 

 patient recruitment

Attendees at our previous conferences said...

"Very good" Senior Representative, Wyeth

"Very good. Well organised" Senior Representative, Antisoma Research

"Informative and good networking opportunities" Senior Representative, Unichem

"Well organised and efficiently run and chaired" Senior Representative, DHL Express Europe

Who should attend this event?

Executive Directors, Vice Presidents, Directors, Heads, Managers and Team Leaders of

  • Clinical Supply Operations
  • Clinical Trials Logistics
  • Clinical/Investigational Supplies
  • Shipping and Distribution
  • Clinical Labelling/Packaging
  • Clinical Trials Material Management
  • Clinical Supplies Manufacturing
  • Clinical Quality Assurance/Quality Control
  • Regulatory Affairs
  • Import-Export Trade Compliance
  • Project Managment
  • Interactive Voice Response Systems/IVRS
  • Clinical Research/Planning
  • Drug Supply Management
  • Sourcing and Procurement

Delegates at our previous clinical trial logistisc conferences came from across the world

Graph of delegates by region

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sylvie Noirault

Sylvie Noirault, Packaging & Distribution Demand Management Head, Sanofi Aventis

9:10 Customs, trade and risk management for supply chain modelling

Elizabeth Foster

Elizabeth Foster, Global Trade Compliance Manager, Novartis Pharmaceuticals

9:50 Case Study: Essential steps towards successful Clinical Trial Supplies in Eastern European countries

Annegret  Van der Aa

Annegret Van der Aa, Clinical Trial Manager, Galapagos

  • Rationale for conducting studies in EEU countries
  • Additional regulatory challenges in EEU countries
  • Case study: real-life experience & lessons learned
  • 10:30 Morning Coffee

    11:00 Risk management in a global market

    Sue Lee

    Sue Lee, Manager BioPharm Systems R&D, World Courier

  • Understanding, analysing and preparing for risk
  • Appropriate SOPs and documentation needs for regulators
  • Focus on particular challenges for trials with sites in emerging markets
  • 11:40 Optimize Supply Chain

    Sylvie Noirault

    Sylvie Noirault, Packaging & Distribution Demand Management Head, Sanofi Aventis

  • Rationalize Distribution network
  • Design Integrated Supply Chain
  • Implement Lower Scale Targeted Changes
  • 12:20 Networking Lunch

    13:40 Understanding the role of specialist logistics providers in your supply chain

    Mike Bradshaw

    Mike Bradshaw, Global sales and marketing director, Biocair International Ltd

  • Discuss the ways a specialist courier can address quality issues that an integrator can’t
  • The shipping compliance risks that arise when organising the logistics of a Clinical Trial or R&D shipments
  • How a specialist courier can add value and reduce costs
  • Supply Chain innovation, services for the future
  • 14:20 Comparator sourcing challenges in the EU markets

    Jonah Randria

    Jonah Randria, Head of Clinical Supply Chain, Pfizer France

  • Alleviating challenges
  • Minimise risk
  • Highlight product pricing issues
  • Identify novel distribution strategy
  • 15:00 Afternoon Tea

    15:30 Taking comparator procurement to the next level

    Robert Donnell

    Robert Donnell, Business Development & Consultancy , Durbin Plc

    • Working in partnership with innovators and specialist providers
    • Sourcing of rescue medications, standard of care medications and ancillaries
    • Internal country sourcing and distribution strategies
    • Sourcing in new emerging markets
     

    16:10 Chairman’s Closing Remarks

    16:20 Drinks Reception

    17:20 Close of Day One

    8:30 Re-Registration & Coffee

    9:00 Chairman's Opening Remarks

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    9:10 What was, what is and what will be - changing paradigms from biologics to regenerative medicine

  • Logistics for clinical trials involving biologics and advanced therapeutics
  • Extra challenges compared to conventional trials
  • Sharon Grimster

    Sharon Grimster, Director, in2phase Ltd

    Evelyn Edwards

    Evelyn Edwards, Supply Chain Consultant, in2phase Ltd

    9:50 Avoiding disappointment with your logistics partner

    Tim Saint

    Tim Saint, Business Development Manager, Marken

  • Agree relationship terms
  • Identify core teams
  • Project management
  • Study set up
  • Operational processes
  • Audit
  • KPIs
  • 10:30 Morning Coffee

    11:00 Assuring Successful Clinical Trials the Role of the Logistics Provider

    Marcelo Reggiardo

    Marcelo Reggiardo, President, OCASA Logistics Solutions

    • Roles and Responsibilities
    • Information is key
    • Establishing Realistic Expectation
    • Examples

    11:40 PANEL DISCUSSION - Establishing a Cold Supply Chain in emerging markets

  • The need for a Quality Management System (QMS) approach in the logistics chain
  • Evaluating the responsibilities of the shipper, forwarder, ground handler, transportation srvice provider, consignee and air carrier
  • IATA Chapter 17 - what are the benefits to the international healthcare logistics sector
  • The new Time and Temperature-Sensitive label - background to its development and clarifying its use
  • Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    Sue Lee

    Sue Lee, Manager BioPharm Systems R&D, World Courier

    Jane Seeley

    Jane Seeley, MD, GeoStasis Ltd

    12:30 Networking Lunch

    13:50 process and recent developments in Russia, Ukraine and Belarus

    Vsevolod  Shimokhin

    Vsevolod Shimokhin , General Director, IMP Logistics

  • Regulatory process in Russia, Ukraine and Belarus related to Clinical Trials Materials supply
  • Recent developments in legislations affecting it
  • Most common issues on the way to import materials and possible solutions
  • 14:30 Successfully developing a predominately airborne clinical trial shipping programme

    Jane Maureen Valentin

    Jane Maureen Valentin, Logistics & Shipping Analyst, Novo Nordisk A/S

  • Understanding the drivers behind the use of air transport rather than land
  • Using airborne supply networks to reduce the risks in customs hold ups and temperature deviations
  • Establishing clear, accountable KPI's with your partners to ensure high quality and timely supply
  • 15:10 Driving Innovation through the Cold Chain

    Jane  Seeley

    Jane Seeley, Managing Director, GeoStasis Ltd

  • The Cold Chain Challenge
  • Process, Economics and Technology advancements
  • How Lean is your Cold Chain?
  • 15:50 Afternoon Tea

    16:20 Chairman’s Closing Remarks and Close of Conference

    +

    Workshops

    Management of Risk in Clinical Trial Logistic Programmes
    Workshop

    Management of Risk in Clinical Trial Logistic Programmes

    Marriott Regents Park
    18th May 2011
    London, United Kingdom

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

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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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