Implementing ICH Q9(R1) Will Entail a Heightened Focus on Integrating Knowledge into Risk-Based Decision-Making
Full implementation of the revisions that have been made to ICH’s Q9 guideline on quality risk management (QRM) will entail a heightened focus on how to best integrate knowledge into risk-based decision-making (RBDM) and is expected to be a mid-term rather than short-term project, according to the rapporteur and members of the guideline revision Expert Working Group (EWG).
Part I: Insights from Expert Working Group Members on ICH Q9 Revisions
Part II: Panel Discussion Among PRST Meeting KM/QRM Experts
[The Introduction is openly available. Parts I - II are available to subscribers. Parts III - IV of the story will be released over the next few days.]
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| IPQ’s meeting schedule through December includes: | |||
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OCTOBER |
NOVEMBER |
DECEMBER |
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CASSS Mass Spec Symposium CASSS HOS Symposium FDA Compounding Quality Annual Conference PDA BioManufacturing Conference CDER SBIA Generics Development Conference IFPMA Africa Regulatory Conference ASGCT Policy Summit PDA/FDA Regulatory Conference CASSS CMC Forum Latin America CHPA Regulatory, Scientific, and Quality Conference CASSS CE Pharm Symposium FDA/PQRI AI in Manufacturing Workshop MedTech & Pharma Platform Annual Conference IPEC Europe Excipient Conference CDER SBIA eDRLS Conference FDA Recall Modernization Meeting |
PDA Microbiology Conference RAPS Convergence 2023 ARM Meeting on the Mesa BioFlorida Conference ISPE Annual Meeting PDA Smart Devices Workshop CASSS CMC Forum Europe World Vaccine Congress PDA Injection Devices Conference BSMA EUROPE Annual Conference AAPS PharmSci 360 TOPRA Symposium TIDES Europe PDA Aseptic Bio Conference |
CASSS CMC Strategy Forum Latin America PDA Quality & Regulations Conference NSF Future of Quality Conference PET: Product Quality, Facility Inspections Workshop PDA Asia Pacific Regulatory Conference AFDO/RAPS Combination Products Summit |
CASSS CMC Strategy Forum Japan MIT 2023 BioMan Summit JPAG Regulatory Symposium |
IPQ would like to thank our partners:
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