Daiichi Sankyo to address the importance of labelling investigational medical products at the 10th Clinical Trial Logistics

Top Quote SMi reports : The 10th Clinical Trial Logistics event takes place in London on 18-19 May. End Quote
  • (1888PressRelease) February 17, 2016 - The exponential growth of the clinical trials logistics market is partnered with significant changes to the regulatory landscape. With the implementation of Annex 15 of the Good Manufacturing Practice (GMP) and the development of the new EU Clinical Trials Regulation, all parties involved in the clinical supply chain will be impacted and would need to adapt for successful compliance.

    SMI's 10th Clinical Trial Logistics event will bring together leading industry experts to address the latest regulatory developments, explore how to reduce costs, learn about the logistical challenges in emerging markets, examine the latest innovations including maintaining temperature in shipment and correct labelling.

    SMi is pleased to announce that Tony Moult, Director of Clinical Supplies Operations at Daiichi Sankyo, will be presenting on Day One of the conference to address the importance of labelling. His notable presentation entitled "EU CTR Annex VI: Labelling of investigational medicinal products (IMPs)" will cover the following topics:
    CTR timing with respect to labels on IMPs
    Examining the increased complexity of packaging and labelling of IMPs
    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 changed

    Other notable presentation from expert speakers include:
    Implementing a compliant and patient-centric clinical supply strategy
    Rocio Cuadrado, TSOM Leader Clinical Supplies SCP - Studies & Distribution, Sanofi

    The Importance of forecasting and supply planning in avoiding logistical delays
    Elisabetta Carli, Head - Operations Clinical Vaccines Management, GlaxoSmithKline

    Comparators in clinical trials: effective meets flexible supply chain
    Jasmin Hellwig, Senior Comparator Specialist, Merck Sharp and Dohme

    Challenges in air freighting time and temerature shipments
    Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo

    Temperature excursion management
    Alexandra Tsioni, Clinical Supply Chain Lead - Global Clinical Operations, Teva

    PANEL DISCUSSION: The Falsified Medicine Directive
    Geoffroy Bessaud, Associate Vice President, Anti-Counterfeiting Coordination, Sanofi
    Amer Alghabban, VP GxP Quality Assurance, Compliance & Training, Karyopharm Therapeutics
    Ulrike Kreysa, Vice President Healthcare, GS1 Global Office

    Visit the event website at http://www.clinical-trial-logistics.com/1888 and take advantage of the Early Bird offer. Register before 29 February to save 400 off the conference price.

    For sponsorship opportunities contact Alia Malick on +44 (0) 20 7827 6168 or email amalick ( @ ) smi-online dot co dot uk

    For delegate bookings contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum ( @ ) smi-online dot co dot uk

    For media enquiries contact Honey de Gracia on +44 (0) 20 7827 6102 or email hdegracia ( @ ) smi-online dot co dot uk

    10th Clinical Trial Logistics
    18-19 May 2016
    London, UK
    Event Website: www.clinical-trial-logistics.com/1888

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