The ICH Q12 guideline aims to harmonize post-approval change management, addressing delays and supply issues in the pharmaceutical industry. Global adoption is limited, with only three ICH countries ...

Indian pharma industry sees that the International Council for Harmonisation (ICH) guidance for industry on Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management ...

The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...

To the casual observer, the International Conference on Harmonisation (ICH) could appear to be a fusty but uncontroversial group. Yet ICH's position in the highly charged debate over how quality ...

Indian pharma is accelerating its push toward global regulatory harmonization as authorities intensify efforts to align domestic standards with stringent International Council for Harmonisation (ICH) ...

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 ...

Pharma Lessons is pleased to announce the launch of its newly revised Good Clinical Practice (GCP) online training course, now fully aligned with the latest ICH GCP E6(R3) guidance. This update ...

RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as ...

It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the ...

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...