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08-May-2018 17:00

Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory agencies.

This IMDRF Good Regulatory Review Practices document provides a common set of conduct, education, experience, competence, and training requirements that shall be established and maintained by the Regulatory Authorities and/or their recognized Conformity Assessment Bodies (CAB) for individuals who perform regulatory reviews of medical devices.

Anika looks at Shivaay being taken out of the hospital, she gets shocked and starts following the ambulance. Soumya tries to convince Pinky to not wake Shivaay up.

Rudra tells her that he will stand for Shivaay’s right. She tells them that Pinky is his mom and she knows best for him. Pinky tells Shivaay that she won’t let anything happen to him and that his bad omen will also be gone like Anika.

In the morning, participants had an opportunity to hear regulatory updates from Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore and USA and update reports on IMDRF’s current work items.

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On third day Management committee took an overview on current work and progress achieved and then approved some final documents relating to the adverse event reporting and also approved data exchange guidelines.

Coming Wednesday, January 21st, we will be updating S-Risk to version to eliminate a few minor issues introduced with 1.0.12.