Mastering Clinical Trial Documents 2016: Being ready for regulation inspections

Top Quote SMi's Mastering Clinical Trial Documents masterclass will take place on the 16th March 2016 in London. End Quote
  • (1888PressRelease) February 16, 2016 - Good records management not only has an impact on how effectively an organisation manages its records during the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections.

    In light of the new EU regulation, 5362014, being implemented in May 2016, it is imperative to be up to date with the latest requirements revolving around the documentation of clinical trials.

    Through interactive discussions and group activities, this full-day CPD-credited masterclass led by Russell Joyce, Heath Barrowcliff Consulting Ltd., will outline: regulations relating to Trial Master File (TMF), including best practice guidance and the latest thinking from legislators and regulators as well as how clinical study records can be created and managed in both the immediate and long-term to ensure the timely availability of an inspection-ready TMF.

    To register visit the event website or contact Matthew Apps on +44 20 7827 6093 or email: mapps ( @ ) smi-online dot co dot uk

    Understand the requirements for clinical study records
    Comprehend how records can be managed more effectively
    Learn how to make best use of clinical study records to enhance information sharing and facilitate more efficient operations
    Improve inspection - readiness to avoid resource-intensive preparations when notified of impending audits and inspections

    The masterclass will be hosted by Russell Joyce, Director of Heath Barrowcliff Consulting Ltd. To gain more insight into the masterclass benefits, visit the downloads section of the event website for an exclusive interview.

    There is currently an EARLY BIRD offer saving 50 off the current price which is available until the 29th FEBRUARY 2016.

    For more information or to register visit the event website or contact Matthew Apps on +44 20 7827 6093 or email: mapps ( @ ) smi-online dot co dot uk

    Mastering Clinical Trial Documents Masterclass
    London, UK
    SMi Group
    Email: zgale ( @ ) smi-online dot co dot uk
    Phone: Matthew Apps on +44 20 7827 6093

    About SMi Group:
    Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the worlds most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at

  • FB Icon Twitter Icon In-Icon
Contact Information