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CMC Innovation Support Programs Advance at EMA and FDA, with Distributed and Continuous Manufacturing on Front Burner

The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies.

On both sides of the Atlantic, a significant effort is underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena. In this four-part story, IPQ explores the latest advancements in the EMA and FDA innovation support programs and the priorities that are now drawing front-burner attention.

PART I: European Regulatory Network Support for Manufacturing Innovation

PART II: FDA’s Expanding Engagement with Advanced Technologies

PART III: Barriers to CM Adoption Explored at USP/RAPS Workshop

Part IV: Distributed/POC Manufacturing and the CMC/Quality Regulatory Paradigm

● Updates in Brief

IPQ

● FDA Warning Letters

● EMA NCRs

● FDA Drug Recalls

From breaking news to in-depth analysis — the quality regulatory intelligence you need at your fingertips!

IPQ’s meeting schedule through March includes:

DECEMBER

JANUARY

FEBRUARY

MARCH

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

EPiC GMDP Compliance Symposium
(Dec 5) Virtual Only

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

FDLI Compliance Conference
(Dec 6-7) Washington, DC

JPAG Regulatory Symposium
(Dec 7) London, England

FDA/Complex Generics: Excipients Workshop
(Dec 7-8) Rockville, MD

ISPE Pharma 4.0 and Annex 1
(Dec 11-12) Barcelona, Spain

DIA CGT Symposium in Japan
(Jan 15-16) Tokyo, Japan

CASSS CMC Strategy Forum North America
(Jan 22) Washington, DC

CASSS WCBP
(Jan 23-25) Washington, DC

ISPE Facilities of the Future
(Jan 29-30) San Francisco, CA

DIA/RAPS Combination Products Summit
(Jan 30-31) Brussels, Belgium

DIA ASAP Process Conference
(Feb 4) Baltimore, MD

DIA Risk Management Strategies Conference
(Feb 5-7) Baltimore, MD

AAM Access! Annual Meeting
(Feb 5-7) Tampa, FL

FDA/MHRA/HC GCP Pharmacovigilance Workshop
(Feb 13-15) College Park, MD

USP Biologics Stakeholder Forum
(Feb 22) Rockville, MD

USP mRNA Forum
(Feb 28-29) Virtual Only

IFPAC Conference
(Mar 3-6) Bethesda, MD

UGA GMP Conference
(Mar 4-7) Athens, GA

DIA Europe
(Mar 12-14) Brussels, Belgium

ISPE Aseptic Conference
(Mar 12-13) Vienna, Austria

PDA Annual Meeting
(Mar 25-27) Long Beach, CA

PDA CDMO Partnership Workshop
(Mar 28-29) Long Beach, CA

IPQ would like to thank our partners: