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Honourable Dr. G. N. Singh, Drug Controller General of India presented a Momento by our Director Mr. Syed S. Abbas & Principal Advisor Mr. Vinod Arora on the launch of our Computer System Validation (CSV) programme

IGMPI is conferred with ASSOCHAM Services Excellence Award 2017: Our Directors Mr Syed S. Abbas & Mrs Rafat Abedi, Chief Advisor Dr Mahesh Gupta, Advisor Mr Amitabh Srivastava are being honoured by the Chief Guest & Honorable Member of Parliament Dr. Udit Raj

 

ICH Addendum for collecting data from multiregional clinical trials adopted by FDA

ICH Addendum for collecting data from multiregional clinical trials adopted by FDA

The US Food and Drug Administration has adopted an addendum to the International Council for Harmonization (ICH) guidance. The addendum has been adopted to help the sponsors from Pharmaceutical companies to collect data from multiregional clinical trials (MRCTs).

There are seven principles laid down in “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials”. Some important principles include “prespecified pooling of regions or subpopulations, “a structured exploration to examine the consistency of treatment effects across regions and subpopulations,” efficient communication among sponsors and regulatory authorities,” and FDA’s adopted version of ICH’s E6(R2) Good Clinical Practice: Integrated Addendum to E6 (R1), which was released in February, with the aim to ensure the quality and interpretability of multiregional clinical trial study results.

According to the new 24 page ICH guidance,” It is important for the multiregional clinical trials data to be accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs.” The guidance also laid down recommendations to address issues related to the planning and designing of multiregional clinical trials which include choice of endpoints and comparators.