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SMi are proud to present their 7th annual Clinical Trial Logistics Conference. This exciting event will bring together industry experts from a variety of different backgrounds including big pharma, regulatory agencies, CROs and logistics companies to discuss the latest developments in this fast-paced and growing sector.

The 2013 conference will explore the latest regulations facing the logistics sector, and will focus on the new EU GDPs and their influences on distribution practices. The growing number of clinical trials taking place in emerging markets will also be discussed and attendees will be presented with a number of case studies on security, contractor and transportation issues.

  • Understand the effects of new GDP guidelines
  • Develop strategies to comply with import and export regulations
  • Evaluate the benefits and regulatory considerations of clinical trials in emerging markets
  • Consider the importance of communication in transparency when working with shippers
  • Discuss  latest trends in cold chain distribution
  • Anaylse risk preparation techniques and effective statistical modelling
  • Hear about the latest security and packaging developments from industry leaders

 

 

You should attend this event if you a are a Director, Area Head, Chief Executive, CSO, or Vice President within the Pharmaceutical or Healthcare industry with responsibilities in the following areas:

Clinical Trial Supplies
Global Logistics Planning
Global Outsourcing Clinical R&D
Clinical Trial Material Management
European Commercial Distribution
Clinical Trial Supply Outsourcing
Quality Assurance
Packaging

Planning and Co-ordination
Research Operations
Supply Chain Management
Clinical Research Management
Clinical Supply Chain
Distribution and Channel Management
Shipping and Trade Compliance
Transportation

A4P Consulting; Actelion Pharmaceuticals; Allergan Ltd; Almac Clinical Services; Amgen BV; Amgen Ltd; Biocair; Biocair International Ltd; Biogen Idec; Biomap; BTG; Catalent Pharma Solutions Inc; Celgene; Chiltern Cold Storage Group ; Cogent Validation Services; Cool Logistics; Creapham Europe; Cryopak/Escort; Eisai Europe Ltd; Elpro UK Ltd; Ferring Pharmaceuticals A/S; FibroGen Inc; Genzyme Therapeutics; GlaxoSmithKline; GS1 UK; GSK; GSK R&D; Guys and St Thomas's NHS Foundation Trust; GW Pharma; GxPi; Health Protection Agency; Helsinn Healthcare SA; Imperial College London; Imperial College London West London Renal and Transplant Centre Hammersmith Hospital; Intelleflex Inc.; IPSEN; Kings College London; KOWA; Marken Limited; Medco Health Solutions; Mundipharma Research ; Pauwels Consulting; Peeks Pharmacy; Peter East Associates Ltd; Pfizer; Pfizer Inc; Pharma Publications; Quanta Consulting; Queen Mary; QuickSTAT; ROCHE; Roche Products; SCA Cool Logistics; SELCRN; Sensitech; Sensitech Incorporated; Sensitech UK Ltd; SOFRIGAM; South East London Cancer Research Network; South London Health; Teva Pharmaceuticals Ltd; The Cure Parkinsons Trust; The Lewisham Hospital N H S Trust; University Of Jena; World Courier;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Sharai Chitando

Sharai Chitando, Lead Research Nurse, Guys and St Thomas's NHS Foundation Trust

9:10 Comparator products – Evaluation of blinding, packaging and sourcing

Sandra Hoffmann

Sandra Hoffmann, Project Manager Oncology, CTSU, Boehringer-Ingelheim

• Understanding the assessment of comparator products
• Identifying the common challenges when using a product you don’t know
• Assessing comparators vs non-IMPs
• Evaluating blinding and packaging options
• Consideration of sourcing strategies

9:50 Risk preparation and management

Sue Lee

Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

• Managing unavoidable risks
• Risk assessment and metrics
• Risk prioritisation
• Risk management and reduction

10:30 Morning Coffee

11:00 Incorporating sustainable phase-change materials into temperature control packaging systems for global pharma and biotech distribution

Michael Considine

Michael Considine, Senior Account Manager, Thermosafe Brands Europe

• New advances in phase change materials
• Strict temperature control for unstable compounds
• Managing costs

11:40 Life after the Falsified Medicines Directive - opportunities and threats

Mike Isles

Mike Isles, Executive Director, European Alliance for Access to Safe Medicines

  • Why the need for the FMD and where are we now?
  • What are the practicalities?
  • What the implications and opportunities for better patient outcomes?
  • 12:20 Networking Lunch

    13:20 “Living Logistics” – Experiences in shipping for clinical trials

    Scott Vincent

    Scott Vincent, Logistics Director, A4Pbio

    • Active logistics management
    • Fast paced and efficient logistics
    • Chain of custody and stability in transport
    • Pan-European Stem Cell distribution – A Case Study

    14:00 Clinical trials in emerging markets

    Biljana Choneska Jovanova

    Biljana Choneska Jovanova, Head of Department for Solid Tumors , University Clinic for Children's Diseases Macedonia

    • Keeping track of regulatory challenges
    • Recruiting patients and accredited laboratories
    • Understanding and overcoming legal and ethical issues

    14:40 Partnering for effective clinical supply management in emerging markets

    Angus MacLeod

    Angus MacLeod, Sr Manager CPL, Catalent Pharma solutions

    • Identifying and prioritising the complex hurdles associated with emerging Markets
    • Understanding Import and Export requirements and timing
    • Identifying other barriers and challenges to successful trials in emerging markets
    • Overcoming these significant challenges through effective planning and partnering

    15:20 Afternoon Tea

    15:40 Energize the Chain: Bringing vaccines to the most remote parts of the globe

    Harvey Rubin

    Harvey Rubin, Director, University Of Pennsylvania

    • Statement of the problem: The cold chain degrades the further away from the central storage points in the developing world
    • The extent of the problem: 2.5 million children die of vaccine preventable causes
    • The solution to the problem: utilise energy available at cell towers sites to power vaccine refrigeration units even in the most remote parts of the world
    • Implementation: public private partnerships organised through our non-profit organisation - Energize the Chain
    • Examples of implementation: Zimbabwe and other countries

    16:20 UK research set-up and recruitment in the NHS

    Emma Rowan

    Emma Rowan, Industry Manager, West Midlands (South) CLRN

  •  How reserach fits into the NHS
  • How the NHIR is working to improve recruitment and set-up
  • How we deliver this in the West Midlands

     

     

  • 17:00 Close of Day One

    17:10 Chair’s Closing Remarks

    17:20 Drinks Reception - Hosted by World Courier

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

    9:10 Improving efficiency in the supply chain

    Vimal Unewal

    Vimal Unewal, Planning Manager, Ferring Pharmaceuticals Ltd

    • Replenishment by Buffer system model
    •     o   Accuracy on short-term forecast (3-6 months) for buffer calculation
    •     o   Stock replenishment driven by consumption
    • Demand planning on buffer system - End to end supply chain
    •     o   Customer-> Distributor -> Manufacturer -> Vendors (Suppliers)
    • Impact on Stock levels
     

    9:50 Unifying EDC and RTSM for optimized supply chain management

    Simon Wilson

    Simon Wilson, Subject Matter Expert Clinical, ArisGlobal

  • Understanding the impact of a fractured flow of supply chain information in your organisation
  • How unifying EDC and RTSM overcomes the challenges
  • Examples of unification benefits
  • 10:30 Morning Coffee

    11:00 Creating efficiency by integrating stability data into your monitoring solution

    Martin Peter

    Martin Peter, Director, Elpro-Buchs AG

    • Critically assessing the benefits of multi-level alarms
    • Understanding what data is necessary to support alarm levels
    • Building a more efficient product release process
    • Reviewing the reaction of different stakeholders

    11:40 Logistics of Clinical Trials in Ukraine: How to avoid the Pitfalls

    Nataliia Bazylevych

    Nataliia Bazylevych, Business Development Manager, SMO Group

  • Existing challenges of the regulatory system in the Ukraine
  • How to deal with unexpected in Ukraine. Recent case studies
  • Study preparation- What really needs to be done to maximise the successful start up in Ukraine
  • 12:20 Networking Lunch

    13:20 Biologics logistics and cold chain distribution

    Sharai Chitando

    Sharai Chitando, Lead Research Nurse, Guys and St Thomas's NHS Foundation Trust

    • New recruiting sites
    • Airway bills
    • Dry Ice Handling
    • Current systems and proposed systems

    14:00 GS1 Standards: Enabling supply efficiency

    Janice Kite

    Janice Kite, Traceability Director Healthcare, GS1

  • Who we are and what we do
  • The case for global supply chain standards
  • Enabling regulatory compliance, e.g. EU Falsified Medicines Directive
  • Improving patient safety and supply chain security through traceability; products, people, processes
  • 14:40 Afternoon Tea

    15:00 Global clinical label management - Experiences at F. Hoffmann-La Roche Ltd

    Rolf Baumgartner

    Rolf Baumgartner, Head Clinical Label Management, Roche Pharmaceuticals

    • Clinical drug supply at F. Hoffmann – La Roche Ltd
    • Label development
    • Approval network in SAP
    • KPIs
    • Challenges

    15:40 An approach to security in a global supply chain

    Tom Cochrane

    Tom Cochrane, Business Process Development Manager, Napp Pharmaceuticals Limited

    • Demonstrating a holistic approach to security in the global supply chain
    • Reviewing the system and identifying risk areas
    • How to tackle and mitigate risks identified

    16:20 Chair’s Closing Remarks

    16:30 Close of Day Two

    +

    FEATURED SPEAKERS

    Biljana Choneska Jovanova

    Biljana Choneska Jovanova

    Head of Department for Solid Tumors , University Clinic for Children's Diseases Macedonia
    Sandra Hoffmann

    Sandra Hoffmann

    Project Manager Oncology, CTSU, Boehringer-Ingelheim
    Vimal Unewal

    Vimal Unewal

    Planning Manager, Ferring Pharmaceuticals Ltd

    Angus MacLeod

    Sr Manager CPL, Catalent Pharma solutions
    Angus MacLeod

    Biljana Choneska Jovanova

    Head of Department for Solid Tumors , University Clinic for Children's Diseases Macedonia
    Biljana Choneska Jovanova

    Emma Rowan

    Industry Manager, West Midlands (South) CLRN
    Emma Rowan

    Harvey Rubin

    Director, University Of Pennsylvania
    Harvey Rubin

    Janice Kite

    Traceability Director Healthcare, GS1
    Janice Kite

    Martin Peter

    Director, Elpro-Buchs AG
    Martin Peter

    Michael Considine

    Senior Account Manager, Thermosafe Brands Europe
    Michael Considine

    Mike Isles

    Executive Director, European Alliance for Access to Safe Medicines
    Mike Isles

    Nataliia Bazylevych

    Business Development Manager, SMO Group
    Nataliia Bazylevych

    Rolf Baumgartner

    Head Clinical Label Management, Roche Pharmaceuticals
    Rolf Baumgartner

    Sandra Hoffmann

    Project Manager Oncology, CTSU, Boehringer-Ingelheim
    Sandra Hoffmann

    Scott Vincent

    Logistics Director, A4Pbio
    Scott Vincent

    Sharai Chitando

    Lead Research Nurse, Guys and St Thomas's NHS Foundation Trust
    Sharai Chitando

    Simon Wilson

    Subject Matter Expert Clinical, ArisGlobal
    Simon Wilson

    Sue Lee

    Regional Quality Manager UK Ireland Middle East & Africa, World Courier
    Sue Lee

    Tom Cochrane

    Business Process Development Manager, Napp Pharmaceuticals Limited
    Tom Cochrane

    Vimal Unewal

    Planning Manager, Ferring Pharmaceuticals Ltd
    Vimal Unewal

    Workshops

    Transport Logistics Strategies
    Workshop

    Transport Logistics Strategies

    Copthorne Tara Hotel
    21st May 2013
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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