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
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| IPQ’s meeting schedule through March includes: | |||
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DECEMBER |
JANUARY |
FEBRUARY |
MARCH |
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CASSS CMC Strategy Forum Japan EPiC GMDP Compliance Symposium MIT 2023 BioMan Summit FDLI Compliance Conference JPAG Regulatory Symposium FDA/Complex Generics: Excipients Workshop ISPE Pharma 4.0 and Annex 1 |
DIA CGT Symposium in Japan CASSS CMC Strategy Forum North America CASSS WCBP ISPE Facilities of the Future DIA/RAPS Combination Products Summit |
DIA ASAP Process Conference DIA Risk Management Strategies Conference AAM Access! Annual Meeting FDA/MHRA/HC GCP Pharmacovigilance Workshop USP Biologics Stakeholder Forum USP mRNA Forum |
IFPAC Conference UGA GMP Conference DIA Europe ISPE Aseptic Conference PDA Annual Meeting PDA CDMO Partnership Workshop |
IPQ would like to thank our partners:
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