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The News In Depth

Role of ICH M4Q and M16 In Modernizing the CMC Regulatory Process Explored at 2026 CASSS WCBP Symposium

The role of ICH M4Q and M16 in creating a more efficient, effective and globally aligned CMC regulatory process that can help release the potential of digitization and advanced data management technologies including artificial intelligence (AI) drew active dialogue from key thought leaders at the concluding session of the 2026 CASSS Well Characterized Biotechnology Product (WCBP) Symposium, which took place in Washington, DC in late January.

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Updates in Brief

FDA Drug Recalls

FDA Warning Letters

EMA NCRs

Quarterly Updates

Hotspots in the Dialogue

IPQ’s meeting schedule through December includes:

SEPTEMBER

OCTOBER

NOVEMBER

DECEMBER

ASGCT Policy Summit
(Sept 14) Washington, DC

PDA/FDA Joint Regulatory Conference
(Sept 14-16) Washington, DC

CASSS Mass Spec Symposium
(Sept 16-18) Rockville, MD

Medtech & Pharma Annual Conference
(Sept 22) Basel, Switzerland

PDA Bioprocess Forum
(Sept 22-23) Milan, Italy

IPEC Europe Excipient Conference
(Sept 22-23) Prague, Czech Republic

CASSS CE Pharm Symposium
(Sept 28-30) Rockville, MD

CHPA Regulatory Conference
(Sept 28-30) Rockville, MD

ISPE Annual Meeting
(Oct 18-21) Washington, DC

World Vaccine Congress Europe
(Oct 19-21) Amsterdam, Netherlands

DIA Middle East & Africa Conference
(Oct 20-21) Abu Dhabi, UAE

CASSS CGTP Europe Symposium
(Oct 20-22) Lisbon, Portugal

AAPS PharmSci 360
(Oct 25-28) New Orleans, LA

PDA Pharmaceutical Microbiology Conference
(Oct 26-28) Washington, DC

GRx+BIOSIMS Conference
(Nov 2-4) Rockville, MD

PDA Aseptic Conference
(Nov 3-4) Incheon, South Korea

DIA India Annual Meeting
(Nov 18-19) Vashi, India

JPAG Regulatory Symposium
(Dec 3) London, U.K.

CASSS CMC Strategy Forum Japan
(Dec 7-8) Tokyo, Japan

MIT BioMAN Summit
(Dec 9-10) Cambridge, MA

ISPE Pharma 4.0™ Conference
(Dec 10-11) Berlin, Germany

FDLI Enforcement Conference
(Dec 10-11) Washington, DC

IPQ would like to thank our partners: