EMA and MHRA Preparing for No Deal Brexit

3/28/2019

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Now that Brexit has been delayed, there is still no guarantee of a deal. The extension will be until April 12 if the withdrawal agreement is not approved by the UK House of Commons by March 29, and until May 22 if it is. During this time, the UK will continue to be a Member State in the EU. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are preparing for the possibility of a no deal Brexit.

New Draft Q&A Guidance on RBM Released: Comment Now!

3/21/2019

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The Food and Drug Administration released a new draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry”. The purpose of the guidance is to provide additional clarification to the finalized Risk Based Monitoring (RBM) guidance from 2013. Questions and answers provide details about:

Exciting Announcement from Clinical Pathways!

3/07/2019

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We have some great news! Our online store is opening mid-March. As a grand opening special, all of our eLearning courses will be offered at a special introductory rate for the first 30 days. Our featured product is DIGR-ACT®, a solution for those looking to improve their critical thinking skills in relation to clinical trials. It helps clinical trial team members manage issues and risks that matter, to dig through and map information to root cause, then to come to valid conclusions on how to act effectively.