Regulatory Affairs Professionals Society

Pharmaceutical industry urges ICH to expand E22 guideline to cover caregiver input

E22 guideline should incorporate caregiver feedback, according to responses submitted by industry groups and manufacturers to ...
Medscape

New Data to Alter Planned Intracerebral Hemorrhage Guidelines

ABU DHABI, UAE — In the past 9 months, a surge of new trials related to the management of intracranial hemorrhage (ICH) has led the European Stroke Organisation (ESO) to delay issuing a planned ...
Regulatory Affairs Professionals Society

Industry calls for synchronized implementation of ICH M4Q(R2)

The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant ...
Yahoo Finance

TransCelerate BioPharma Publishes Resources to Accelerate Industry Adoption of Newly-Released ICH E6(R3) Guidelines

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...
Pharmabiz

Experts recommend ICH guidelines on pharma quality for implementation of revised Schedule M

Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...
PharmiWeb

Statistical Elements of Implementing ICH Quality Guidelines

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best ...
Vanguard

NAFDAC makes history, joins World’s top drug regulators in ICH

Nigeria’s National Agency for Food and Drug Administration and Control, NAFDAC, has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals ...