Category: Standards

Clinical and Performance Evaluation under EU-MDR – New CE Market Rules

August 5, 2021
Standards

Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device....

clinical and performance evaluation, clinical trial Requirements, EU MDR, FDA clinical trial Regulations, Medical Device clinical Investigation Requirements, new ce market rules

ICH E6 Good Clinical Practice Principles

June 30, 2021
Standards

The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial...

Clinical practice, Good clinical practice guidelines India, ICH E6 Guidelines for Good Clinical Practice, ICH GCP principles, ICH good clinical practice principles

Clinical Trial Management Guidelines under Covid-19 – Europe

June 9, 2021
Standards

Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects....

clinical trial management, corona vaccine clinical trails, guidance covid vaccine trails, guidelines under covid-19 Europe, Managing clinical trials during COVID-19

Adverse Reaction Reporting Guide for New Zealand

June 2, 2021
Standards

New Zealand tends to have a high rate when it comes to adverse reaction reporting. The Centre for Adverse Reactions Monitoring (CARM), Dunedin acts as the national repository. This entire data helps...

adverse drug reactions, centre for Adverse Reactions monitoring, guide for adverse reaction reports, pharmacists.

FDA Warning Letter Jan-Apr 2021 Recap Summary

May 6, 2021
Standards

Warning DescriptionProducts & SummaryFDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance...

The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19.

Regulatory Intelligence is a key to Quality and Safety

January 29, 2021
Standards

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

Regulatory Affairs, Regulatory Changes, Regulatory Database, Regulatory Intelligence, Regulatory Intelligence for Biopharma, Regulatory Intelligence for Cosmetics, Regulatory Intelligence for Food Supplements, Regulatory Intelligence for Medical Devices