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SMi's Clinical Trial Logistics conference returns in May 2014 for its 8th incarnation. This is the world’s leading clinical trial logistics conference and exhibition.

Pharmaceutical and biotechnology businesses from across the globe will be meeting to help understand how to negotiate the latest challenges in clinical trial transportation, storage and recruitment in clinical trials.

Senior professionals will have the opportunity to network with peers and colleagues to develop and forge the new relationships that will accelerate your clinical trials.

The efficiency of your supply chain is vital for clinical trials. Navigating the hurdles of trial logistics enables clinical trials to move through the stages to commercialisation. Without efficient monitoring and temperature control in the supply chain the efficacy of the products cannot be guaranteed.

 This world leading conference and delegates offer delegates the opportunities to navigate the latest changes to GDP guidelines, their applicability, time and temperature management and working with logistical and research partners.

 

• In its 8th year this is the longest established Clinical Trial Logistics event globally
• Enhanced networking for delegates through the use of roundtables
• FOCUS sessions on GDP regulations and trials in emerging markets
• Refreshed programme focusing on the latest issues and new speakers
 

EXPANDED EVENT for 2014

  • Head of Supply Chain
  • Planning Manager
  • Head of Pharmacy Services
  • Distribution manger, R&D Supply Chain
  • Senior Operations Manager
  • Clinical Trial Supplies Group Leader
  • Director of Business Innovation
  • Head of International Affairs

 

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Andrea Gruber

Andrea Gruber, Manager, Cargo Business Process and Standards, IATA

9:10 Ensuring compliance to the IATA Regulations for Temperature Sensitive Air Freight shipments

Andrea Gruber

Andrea Gruber, Manager, Cargo Business Process and Standards, IATA

9:50 Adhering to GDP Guidelines on Clinical Trials: How to interpret and accelerate trials?

Riekert Bruinink

Riekert Bruinink, Member of the GDP drafting Group of the EMA, Dutch Health Care Inspectorate

 

  • Find out the latest updates on GDP regulations .
  • What is legally required. Differences  between Member States
  • How can you ensure controlled ambient temperature controlled regulations are adhered to?
  •  

    10:30 Morning refreshments and networking in the exhibition area

    11:00 PANEL: Clinical trial supply chain challenges and comparisons

    • What measures do you have to consider with a clinical trial chain compared to a commercial chain?
    • How and when should your CTL comply with GDP regulations?
    • Managing temperature controlled products in emerging markets

    Vimal Unewal

    Vimal Unewal, Planning Manager, Ferring Pharmaceuticals Ltd

    Bob Hayes

    Bob Hayes, Director, Seer Pharma

    11:40 Near realtime tracking and monitoring – helping to provide GDP compliance and to achieve supply chain certainty

    Leonard Carey

    Leonard Carey, International Business Development, AT&T

    Paul  Rodwell

    Paul Rodwell, International Business Development, OnAsset

    12:20 Networking lunch held in the exhibition area

    13:30 GS1 Standards: Enabling supply efficiency

    Janice Kite

    Janice Kite, Tracibility 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
     

    14:10 Case Study: Managing supply chain efficiency

    Vimal Unewal

    Vimal Unewal, Planning Manager, Ferring Pharmaceuticals Ltd

  • Assessing and prioritising stock replacement based on consumption, not the forecast
  • Implementation - stock replenishment by buffer system model
  • Impact on end-to-end supply chain (Patient – CRO – Manufacturer – Vendors(suppliers))
  • Impact on stock levels


     

  • 14:50 Predictive modelling of clinical trials operations

    Vladimir Anisimov

    Vladimir Anisimov, Senior Strategic Biostatistics Director, Innovation, Quintiles

  • Main uncertainties and risks at clinical trial design
  • Predictive patient enrolment modelling (start-up and interim stages)
  • Modelling operational processes (visits, events, site performance, operational costs)
  • Risk-based supply chain modelling
  • 15:30 Afternoon Tea

    16:00 How can you optimise pharmaceutical road transit

    Peter Cullum

    Peter Cullum, Head of International Affairs, Road Haulage Association

    • Current supply chain challenges

    • Where are the delays occurring?

    • What can you do to reduce cost and optimise deliveries
     

    16:40 NPA: How can big pharma support pharmacy distribution in product development stages?

    Leyla Hannbeck

    Leyla Hannbeck, Head of Pharmacy Services, National Pharmacy Association

     

    ·         About the National Pharmacy Association (NPA)
    ·         A brief description of the work National Pharmacy Association does in representing Community Pharmacy Owners in the UK.                      
    ·         Key Challenges in pharmacy supply
    ·         We will look at some of the key areas that are currently impacting on patient care due to issues caused by the medicines supply chain, including the current legislation, stock shortages and quotas and look into some case studies of successful collaboration between pharmacy and big pharma.
    ·         EU distribution challenges
    ·         Discuss some of the current EU challenges and policies and the impact of these on the current medicines supply chain and how can these be overcome.

     

    17:20 Overcoming key inefficiencies in your supply chain

    Harvey Rubin

    Harvey Rubin, Director, University Of Pennsylvania

    • How can efficient management ensure cost savings in CTS chains?
    • Effectively monitor delays in trial shipping
    •  Identifying your weak spots and how to overcome these
     

    18:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Andrea Gruber

    Andrea Gruber, Manager, Cargo Business Process and Standards, IATA

    9:10 Managing the challenges of clinical supplies in third party blinded studies

    Lesley George

    Lesley George, Supply Chain Lead, Pfizer

    • Review of different scenarios that may be encountered
    • What are the options when defining your blinding strategy?
    • What can go wrong?  Identifying risks and mitigations
     

    9:50 Logistical challenges and strategies for: Russia, Ukraine, Israel

    Angus  MacLeod

    Angus MacLeod, Sr. Manager, CTS, Catalent Pharma Solutions

     

     
    Import and Export Challenges and Solutions.
  •  Discussing the requirements and documentation required when clearing Customs  to enable a smooth supply Chain
  • Timelines for import into the countries
  • The discuss the challenges and solutions to ensure success.
     
    Requirements for audited and approved depot facilities
  • Strong understanding of evolving regulatory environments
  • Drug depots make sense a high number of countries and sites;
  •  Enable an effective clinical logistics system by leveraging appropriate clinical logistics training to relevant personnel.
  •  Manage shipments (i.e. courier companies expertise)internally with in the country
  • 10:30 Morning Coffee

    11:00 The evolution of patient recruitment for Clinical trials via Community pharmacy

    Michele Ingravallo

    Michele Ingravallo, Director of Business Innovation & Transformation, Alliance Boots

    • Ways of completing the recruitment cycle
    • The pharmacy role and involvement within Clinical trials
    • The Clinical trials integrated model in collaboration with the community pharmacy
     

    11:40 Overcoming challenges in the clinical trial supply chain (with supply chain simulation tools)

    Nimer Yusef

    Nimer Yusef, CEO, Trial-Brain

     

  • Why using simulations tools to optimize you supply chain
  • Why you need IVRS
  • What you need to use them
  • What answers they'll give you
  • When they can't help
  • Differences between simulation tools
  • 12:20 Networking Lunch

    13:50 Panel: Discussing efficient methods used when labelling and packaging products

    • What’s the right solution for global labelling inefficiency?
    • Managing time and temperature sensitive labelling
     

    Peter Cullum

    Peter Cullum, Head of International Affairs, Road Haulage Association

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

    14:30 Crisis Management: How to make sure the worst doesn’t come to pass

    Bob Hayes

    Bob Hayes, Director, Seer Pharma

  • Planning to avoid a crisis
  • Tracking and measuring progress
  • Examples from other industries
  • Managing unexpected events                                                                                                                                                                                                                                                         CAPA                                                                                                                                                                                                                                                                                                              Change Control
     

     

  • 15:10 Afternoon Tea

    15:40 Avoiding counterfeit medicines entering trials

    Mike Isles

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

    • Falsified Medicines Directive and its impact on logistics

    •Opportunities and threats

    • How to protect your supply chain

    16:20 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andrea Gruber

    Andrea Gruber

    Manager, Cargo Business Process and Standards, IATA
    Angus  MacLeod

    Angus MacLeod

    Sr. Manager, CTS, Catalent Pharma Solutions
    Harvey Rubin

    Harvey Rubin

    Director, University Of Pennsylvania
    Lesley George

    Lesley George

    Supply Chain Lead, Pfizer
    Leyla Hannbeck

    Leyla Hannbeck

    Head of Pharmacy Services, National Pharmacy Association
    Nimer Yusef

    Nimer Yusef

    CEO, Trial-Brain

    Andrea Gruber

    Manager, Cargo Business Process and Standards, IATA
    Andrea Gruber

    Angus MacLeod

    Sr. Manager, CTS, Catalent Pharma Solutions
    Angus  MacLeod

    Bob Hayes

    Director, Seer Pharma
    Bob Hayes

    Harvey Rubin

    Director, University Of Pennsylvania
    Harvey Rubin

    Janice Kite

    Tracibility Director Healthcare , GS1
    Janice Kite

    Leonard Carey

    International Business Development, AT&T
    Leonard Carey

    Lesley George

    Supply Chain Lead, Pfizer
    Lesley George

    Leyla Hannbeck

    Head of Pharmacy Services, National Pharmacy Association
    Leyla Hannbeck

    Martin Dearden

    Corporate Microbiologist, UCB
    Martin Dearden

    Michele Ingravallo

    Director of Business Innovation & Transformation, Alliance Boots
    Michele Ingravallo

    Mike Isles

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

    Nimer Yusef

    CEO, Trial-Brain
    Nimer Yusef

    Paul Rodwell

    International Business Development, OnAsset
    Paul  Rodwell

    Peter Cullum

    Head of International Affairs, Road Haulage Association
    Peter Cullum

    Riekert Bruinink

    Member of the GDP drafting Group of the EMA, Dutch Health Care Inspectorate
    Riekert Bruinink

    Vimal Unewal

    Planning Manager, Ferring Pharmaceuticals Ltd
    Vimal Unewal

    Vladimir Anisimov

    Senior Strategic Biostatistics Director, Innovation, Quintiles
    Vladimir Anisimov

    Workshops

    Virtual logistics: Managing quality and user acceptance testing
    Workshop

    Virtual logistics: Managing quality and user acceptance testing

    Marriott Regents Park
    20th May 2014
    London, United Kingdom

    Interview with Vimal Unewal

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    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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