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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.]

● Updates in Brief

IPQ

● FDA Warning Letters

● EMA NCRs

● FDA Drug Recalls

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IPQ’s meeting schedule through December includes:

SEPTEMBER

OCTOBER

NOVEMBER

DECEMBER

CASSS Mass Spec Symposium
(Sept 5-8) Chicago, IL

CASSS HOS Symposium
(Sept 6-7) Chicago, IL

FDA Compounding Quality Annual Conference
(Sept 11-13) Virtual Only

PDA BioManufacturing Conference
(Sept 12-13) Seville, Spain

CDER SBIA Generics Development Conference
(Sept 13-14) Virtual Only

IFPMA Africa Regulatory Conference
(Sept 12-15) Virtual Only

ASGCT Policy Summit
(Sept 18-19) Washington, DC

PDA/FDA Regulatory Conference
(Sept 18-20) Washington, DC

CASSS CMC Forum Latin America
(Sept 19) Virtual Only

CHPA Regulatory, Scientific, and Quality Conference
(Sept 19-20) Bethesda, MD

CASSS CE Pharm Symposium
(Sept 24-27) Philadelphia, PA

FDA/PQRI AI in Manufacturing Workshop
(Sept 26-27) Virtual Only

MedTech & Pharma Platform Annual Conference
(Sept 27) Basel, Switzerland

IPEC Europe Excipient Conference
(Sept 27-28) Rotterdam, NL

CDER SBIA eDRLS Conference
(Sept 28) Virtual Only

FDA Recall Modernization Meeting
(Sept 29) Silver Spring, MD

PDA Microbiology Conference
(Oct 2-4) Washington, DC

RAPS Convergence 2023
(Oct 3-5) Montreal, CA

ARM Meeting on the Mesa
(Oct 10-12) Carlsbad, CA

BioFlorida Conference
(Oct 11-13) Ponte Vedra Beach, FL

ISPE Annual Meeting
(Oct 15-18) Las Vegas, NV

PDA Smart Devices Workshop
(Oct 16) Gothenburg, Sweden

CASSS CMC Forum Europe
(Oct 16-18) Stockholm, Sweden

World Vaccine Congress
(Oct 16-19) Barcelona, Spain

PDA Injection Devices Conference
(Oct 17-18) Gothenburg, Sweden

BSMA EUROPE Annual Conference
(Oct 19-20) La Hulpe, Belgium

AAPS PharmSci 360
(Oct 22-25) Orlando, FL

TOPRA Symposium
(Oct 23-25) Lisbon, Portugal

TIDES Europe
(Oct 30-Nov 1) Amsterdam, Netherlands

PDA Aseptic Bio Conference
(Oct 31-Nov 1) Incheon, Korea (South)

CASSS CMC Strategy Forum Latin America
(Nov 7) Virtual Only

PDA Quality & Regulations Conference
(Nov 7-8) Antwerp, Belgium

NSF Future of Quality Conference
(Nov 9) London, UK

PET: Product Quality, Facility Inspections Workshop
(Nov 13-14) Silver Spring, MD

PDA Asia Pacific Regulatory Conference
(Nov 28-29) Melbourne, Australia

AFDO/RAPS Combination Products Summit
(Nov 28-30) Fort Worth, Texas

CASSS CMC Strategy Forum Japan
(Dec 4-5) Tokyo, Japan

MIT 2023 BioMan Summit
(Dec 6-7) Cambridge, MA

JPAG Regulatory Symposium
(Dec 7) London, England

IPQ would like to thank our partners: