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Getting to grips with Annex 16

With the latest update of Annex 16 being introduced last year, implications have begun to emerge within clinical supply. The regulation, approved by the European Commission, specifically outlines the responsibilities of a Qualified Person (QP), in particular to approving and releasing batches. In order to achieve this, there are several procedures which clinical supply companies must follow and as a result the QP’s workload has risen. How will this affect clinical supply?

At this year’s Clinical Trial Supply West Coast conference, we are happy to announce that Robert Bronstein, Director of Clinical Supply Management from Dynavax Technologies will be hosting a debate on this pressing topic; to discuss the stricter requirements for QPs and how this will affect the release of IMP in Europe.

  • Too much or too little? Balancing how much sponsors will need to adapt to meet regulatory changes with the least cost
  • Defining ways in which Annex 16 will place more responsibility on Qualified Persons to ensure that clinical supply are being thoroughly checked with the introduction of a QP declaration
  • Preparing your QP team for the regulatory changes to ensure they are prepared for impending MHRA audits
  • Defining how Annex 16 could have a knock-on effect on other elements of your supply operations, such as forecasting

In addition to this, we will also be discussing the approaches which could be taken to ensure global supply chain are agile and adaptable to regulatory changes, how to maintain a cold chain for highly temperature sensitive supplies to ensure timelines and resources are saved. We hope this event can help you and your company move forward with more confidence in your actions within clinical supply. We look forward to seeing you in May!

For more information about the event please follow this link: http://www.arena-international.com/ctswest/ alternatively, you can email us: evets@arena-international.com






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