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ICH Q3D Implementation Continues with Workshops, Research, and Guideline and Pharmacopeial Revisions

More sensitive and selective methodologies have facilitated the identification and quantification of elemental impurities (EIs) in pharmaceuticals and the movement away from the old heavy metal analytical tests to the newer risk-based assessment strategy of ICH Q3D.

Part I: Role of PQRI/FDA Workshop in Q3D Implementation Dialogue

Part II: Regulatory Experience and Perspectives in Implementing Q3D

Part III: Pharmacopeial Harmonization with ICH Q3D

Part IV: Outcomes of PQRI Study on Variability in Elemental Impurity Analysis

Updates in Brief

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EMA Non-Compliance Reports

FDA Drug Recalls

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IPQ’s meeting schedule through April includes:

JANUARY

FEBRUARY

MARCH

APRIL

CERSI Regulatory Science Summit
(Jan 8) San Francisco, CA

IABS Globally Harmonized Specs Meeting
(Jan 10-12) Basel, Switzerland

CASSS CMC Strategy Forum North America
(Jan 23) Washington, DC

CASSS WCBP Symposium
(Jan 24-26) Washington, DC

ISPE Facilities of the Future
(Jan 31-Feb 1) Bethesda, MD

USP Compounding Implementation Workshop
(Feb 7-8) Rockville, MD

DIA Regulatory Submissions, Information, and Document Management Forum
(Feb 13-15) Bethesda, MD

AAM Annual Meeting
(Feb 13-15) Orlando, FL

25th IGBA Annual Conference
(Feb 15-16) Orlando, FL

USP Dietary Supplement and Herbal Medicine Stakeholder Forum
(Feb 16) Rockville, MD

IABS COVID-19 Vaccines Meeting
(Feb 16-17) Antwerp, Belgium

MHRA GMP/GDP Symposia
(Feb 21-22) London, UK

PDA Annex 1 Workshop
(Feb 27-28) Raleigh, NC

2023 PDA Contamination Control Strategy Workshop
(Mar 1-2) Raleigh, NC

ISPE Aseptic Conference
(Mar 6-7) North Bethesda, MD

DIA Latin America Annual
(Mar 6-8) Virtual Only

UGA/FDA International GMP Conference
(Mar 6-9) Athens, GA

TIDES ASIA Conference: Oligo, Peptide, mRNA and Drug Delivery
(Mar 7-9) Kyoto, Japan

BSMA Summit
(Mar 8-9) Foster City, CA

NIIMBL Big Data Program Workshop
(Mar 15-16) Newark, Delaware

BIO-EUROPE Spring Conference
(Mar 20-22) Basel, Switzerland

DIA Europe
(Mar 22-24) Basel, Switzerland

25th GMP PharmaCongress
(Mar 28-29) Wiesbaden, Germany

CASSS CMC Strategy Forum Latin America
(Mar 29) Virtual Only

DIA/FDA Biostatistics Industry and Regulatory Forum
(Mar 29-31) Virtual Only

PDA Annual Meeting
(Apr 3-5) New Orleans, LA

World Vaccine Congress
(Apr 3-6) Washington, DC

PDA Contamination Control Strategy
(Apr 6-7) New Orleans, LA

ARM Cell & Gene Meeting on the Mediterranean
(Apr 12-14) Barcelona, Spain

PDA Visual Inspection Forum
(Apr 17-18) Baltimore, MD

CASSS Bioassays Symposium
(Apr 17-19) Gaithersburg, MD

PDA Parenteral Packaging Conference
(Apr 18-19) Lido di Venezia, Italy

AAPS National Biotechnology Conference
(Apr 23-26) Philadelphia, PA

IPQ would like to thank our partners: