ICH - Guidelines
How to Apply the ICH E Guidelines: Operational ...
Apply the ICH E Guidelines correctly: monitoring, TMF, risk management, audit trails and pharmacovigilance. Operational guide for QA/QP.
How to Apply the ICH E Guidelines: Operational ...
Apply the ICH E Guidelines correctly: monitoring, TMF, risk management, audit trails and pharmacovigilance. Operational guide for QA/QP.
ICH M Guidelines: how to prepare a CTD/eCTD ste...
Operational procedure to prepare a CTD/eCTD compliant with the ICH M Guidelines. For RA, CMC and QA teams.
ICH M Guidelines: how to prepare a CTD/eCTD ste...
Operational procedure to prepare a CTD/eCTD compliant with the ICH M Guidelines. For RA, CMC and QA teams.
ICH E Guidelines: What QA and QP Need to Know
Discover the principles of the ICH E Guidelines for Clinical Trials and GCP: responsibilities, risks, documentation, and data quality, explained for QA/QP.
ICH E Guidelines: What QA and QP Need to Know
Discover the principles of the ICH E Guidelines for Clinical Trials and GCP: responsibilities, risks, documentation, and data quality, explained for QA/QP.
ICH Q8-Q9-Q10-Q12: how to pass GMP audits
GMP and ICH Q8–Q12 Audits: What Inspectors Check and How to Be Audit-Ready.
ICH Q8-Q9-Q10-Q12: how to pass GMP audits
GMP and ICH Q8–Q12 Audits: What Inspectors Check and How to Be Audit-Ready.
ICH M Guidelines: CTD/eCTD Structure and Global...
Complete guide to the ICH M Guidelines: CTD, eCTD, stability, bioequivalence and global submissions. Ideal for RA, QA and CMC.
ICH M Guidelines: CTD/eCTD Structure and Global...
Complete guide to the ICH M Guidelines: CTD, eCTD, stability, bioequivalence and global submissions. Ideal for RA, QA and CMC.
Q3D + M7: How to Prepare for an Audit on Elemen...
Elemental and mutagenic impurities: what EMA/FDA inspectors look for — and how to keep your dossier audit-ready.
Q3D + M7: How to Prepare for an Audit on Elemen...
Elemental and mutagenic impurities: what EMA/FDA inspectors look for — and how to keep your dossier audit-ready.