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



The Food and Drug Administration released a new draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry”.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!



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.

How Does Brexit With No Withdrawal Agreement Affect Clinical Trials?



The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.