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The News In Depth

Government/Industry/Academia Collaborative Efforts to De-Risk and Accelerate Manufacturing Innovation Draw Strength from Pandemic Learnings

The US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation, as the learnings from the pandemic are further digested. The five-part IPQ story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how NIIMBL and other organizations are seeking to address them in the US and internationally.

Part I: NIIMBL and its “Going First Together” Mantra

Part II: US Manufacturing Innovation Leaders Weigh In

Part III: The Importance of Process and Facility Innovation in Global Health

Part IV: Charting the Advanced Therapy CMC Pathways and Other NIIMBL Projects

Part V: CBER’s Marks on Taking CGTs to the Next Level

Other Developments

● Updates in Brief

IPQ

● FDA Warning Letters

● EMA Non-Compliance Reports

● FDA Drug Recalls

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

Monthly Updates

Hotspots in the Dialogue

IPQ’s meeting schedule through June includes:

MARCH

APRIL

MAY

JUNE

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

Africa Health Agenda International Conference
(Mar 5-8) Kigali, Rwanda

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

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

FDA SBIA Generic Drugs Forum
(Apr 12-13) Virtual Only

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

IPEC Excipient World
(May 2-3) National Harbor, MD

PDA Robotics & Automation Conference
(May 3-4) Amsterdam, The Netherlands

TIDES USA: Oligo and Peptide Conference
(May 7-10) San Diego, CA

ISPE Europe Annual Conference
(May 8-10) Amsterdam, The Netherlands

ARM Cell & Gene Congressional Fly-In
(May 9-10) Washington, DC

CASSS AT Europe Symposium
(May 9-12) Rotterdam, The Netherlands

PDA Annex 1 Workshop
(May 16-17) Singapore

ASGCT 26th Annual Meeting
(May 16-20) Los Angeles, CA

FDLI Annual Conference
(May 17-18) Washington, DC

PDA Aseptic GMP Conference
(May 23-24) Leipzig, Germany

PDA Site Visit at IDT Biologika
(May 25) Dessauy-RoBlau, Germany

IFPAC Conference
(June 4-7) Washington DC

ARM Cell & Gene Reception @ BIO
(June 5) San Diego, CA

BIO International Convention
(June 5-8) Boston, MA

PDA ATMP Conference
(June 7-8) Baltimore, MD

Longwood/MIT Spring Webconference
(June 7-8) Virtual Only

PDA Virus Conference
(June 20-21) Madrid, Spain

IABS Vaccine Reference Standards Workshop
(June 21-22) Ottawa, Canada

DIA Global Annual Meeting
(June 25-29) Boston, MA

CASSS CGTP Summit
(June 26) Rockville, MD

ISPE Biotech Conference
(June 26-27) Dublin, Ireland

CASSS CGTP Symposium
(June 27-29) Rockville, MD

NIIMBL National Meeting
(June 27-27) Washington, DC

IPQ would like to thank our partners:
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