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The News In Depth

USP Continues to Refine Its Strategies for Keeping Pace with and Supporting the Rapidly Advancing Biotechnology in the MAb, Vaccine and CGT Arenas

USP is continuing to evolve and refine its strategies for providing standards that can keep pace with and support the rapid advances in biotechnology taking place across the monoclonal antibody (mAb), vaccine, and the cell and gene therapy (CGT) landscape.

Part I: USP Bio Stakeholder Forum Opening Remarks and Mass Spec Standards for Proteins

Part II: USP's CGT Initiatives

Part III: FDA and Industry Experience with CAR T Potency Testing

Part IV: Update on USP Strategies and Initiatives in the MAb, Vaccine, and CGT Arena

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 September includes:

JUNE

JULY

AUGUST

SEPTEMBER

TU Dublin Q9(R1) Seminar
(June 1) Dublin, Ireland

IFPAC Conference
(June 4-7) Washington DC

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

FDA Regulatory Education Annual Conference
(June 5-9) Virtual Only

CASSS CMC Strategy Forum Latin America
(June 6) Virtual Only

ECA GMP for Medical Cannabis Conference
(June 6-7) Virtual Only

ARMI Meeting in the Millyard
(June 6-8) Manchester, NH

PDA ATMP Viral Safety Workshop
(June 7-8) Baltimore, MD

Longwood/MIT Spring Webconference
(June 7-8) Cambridge, MA

FDLI Cannabis Regulation Conference
(June 7-8) Washington, DC

FDA/Duke-Margolis Advanced Manufacturing Workshop
(June 8) Washington, DC

PQRI Titanium Dioxide Regulatory Workshop
(June 13-14) Washington, DC

Medicines for Europe Annual Conference
(June 14-16) Malta

PDA Viral Safety for ATMPS Workshop
(June 19) Madrid, Spain

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

EU competitiveness in ATMP
(June 27) Stockholm, Sweden

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

NIIMBL National Meeting
(June 27-29) Washington, DC

ATMP Sweden World Tour
(June 28-30) Virtual Only

PDA Cell and Gene Conference
(July 12-13) Tokyo, Japan

DIA CoRE Singapore Annual
(July 12-13) Singapore

CASSS CMC Strategy Forum North America
(July 17-18) Gaithersburg, MD

USP Continuous Manufacturing Workshop
(July 18-19) Rockville, MD

15th Annual Bioprocessing Summit
(Aug 14-17) Boston, MA

PDA Manufacturing & Quality Conference
(Aug 15-16) Singapore

ISPE Singapore Conference
(Aug 23-25) Singapore

CASSS HOS Symposium
(Sept 6-7) United States

CASSS MS Conference
(Sept 6-8) Chicago, IL

PDA BioManufacturing Conference
(Sept 12-13) Seville, Spain

IFPMA Africa Regulatory Conference
(Sept 12-15) Virtual Only

PDA/FDA Regulatory Conference
(Sept 18-20) Washington, DC

CASSS CMC Forum Latin America
(Sept 19) Virtual Only

CHPA Regulatory, Scientific, and Quality Conference
(Sept 19-20) Bethesda, MD

CASSS CE Pharm Symposium
(Sept 24-27) Philadelphia, PA

MedTech & Pharma Platform Annual Conference
(Sept 27) Basel, Switzerland

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