Prepare for Changing Regulations
Regulatory changes are already frequent within the world of clinical supplies, however there is even further uncertainty following the election of Trump, and Brexit. Many sponsor companies worldwide are asking how the regulations of the supply chain may continue to change. This event will prove a key meeting point for delegates to discuss how they can prepare for inbound or active regulatory changes which will happen as a result of political changes.
One standout session will be a discussion of how companies can prepare for Annex 16, being co-hosted by the Director of ClinicalSuppliesManagement and the Senior Quality Director from Dynavax Technologies. Annex 16 is a key regulatory change that will impact all supplies entering into the EU as it will place greater amounts of accountability on the QP persons, and companies need to know how they will adapt to this regulation. Clinical Trial Supply West Coast will prove the perfect platform to discuss this key issue.
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