IPQ.org https://validator.w3.org/feed/docs/rss2.html FDA Inspection Experts Explore the Continuing Problem of Data Integrity and where Solutions Lie IPQ Monthly Update – September/October 2025 in Review Week Ending October 31, 2025: Featuring a Panel of FDA Compliance Leaders Discussing Key Current Concerns IPQ Monthly Update June 2025 IPQ Monthly Update – November 2025 in Review EFPIA’s Biomanufacturing Agenda is Targeting Increased Risk-based Regulatory Flexibility IPQ Staff IPQ Monthly Update – December 2025 in Review Role of ICH M4Q and M16 In Modernizing the CMC Regulatory Process Explored at 2026 CASSS WCBP Symposium Hotspots in the Dialogue Weeks Ending October 17 & 24, 2025: Featuring CBER, CDER, CVM and OII Compliance Updates Weeks Ending October 3 & 10, 2025: Featuring FDA Compliance and Inspection Leaders on the Current Enforcement Landscape Week Ending June 27, 2025: Featuring USP’s Koduri on Advancing Global Biosimilar Development Archives Weeks Ending September 5 & 12, 2025: Featuring FDA’s Godwin on Recent Drug GMP Trends and Enforcement Activities Home IPQ Monthly Update – August 2025 in Review Week Ending July 25, 2025: Featuring EMA’s Rogers on CMC Problems and Harmonization Efforts for ATMPs Weeks Ending August 1 & 8, 2025: Featuring Health Canada’s Yeung at CASSS Bioconjugate/Multispecific Forum Weeks Ending September 19 & 26, 2025: Featuring FDA’s Swoboda on CBER Compliance Trends and Center/Field Reorganization Subscription Information IPQ Monthly Update – June 2025 in Review Former FDA Regulators Shapiro and Duncan Weigh In on the CMC Challenges of Bioconjugates and Multispecifics at CASSS Forum IPQ Monthly Update – July 2025 in Review Weeks Ending August 15 & 22, 2025: Featuring Japan and Chile Regulators on the Evolving Bioconjugate/Multispecific Landscape Week Ending August 29, 2025: Featuring Regulatory Panel Discussion of Bioconjugate and Multispecific CMC Challenges Weeks Ending July 4 & 11, 2025: Featuring International Panel on Regulator Initiatives to Support CGTs Week Ending July 18, 2025: Featuring the Q&A at the June CASSS CGT Symposium Regulator Session IPQ Monthly Update – May 2025 in Review Week Ending May 23, 2025: Featuring MHRA’s Brown on the Agency’s Evolving Compliance Strategy Week Ending June 6, 2025: Featuring USP’s Wang on Pharmacopeial Strategies for Addressing Emerging Excipient/Formulation Challenges Week Ending May 16, 2025: Featuring an Update on PIC/S by MHRA’s Ian Jackson Week Ending May 30, 2025: Featuring MHRA’s Wan on CMC for Individualized mRNA Cancer Immunotherapies IPQ Monthly Update – April 2025 in Review Week Ending May 9, 2025: Featuring Egypt and EMA Regulators on Reliance Progress and Benefits Week Ending April 25, 2025: Featuring MHRA’s Rees and Gray on New UK Regulatory Framework for Decentralized Manufacturing Leveraging mRNA Vaccine CMC Learnings in the Evolving Therapeutics Arena Draws Spotlight at DIA/FDA Conference Week Ending April 11, 2025: Featuring Health Canada’s Joseph on HC Inspection Findings and Advancements Weeks Ending June 13 & 20, 2025: Featuring USP Experts on Supporting Complex Excipients and Formulations Week Ending March 21, 2025: Featuring EMA’s Hernan on the Quality Innovation Group’s role and impact Week Ending May 2, 2025: Featuring EMA’s Kotzagiorgis and Cuddy on ICMRA Pilots and Their Extension Week Ending April 18, 2025: Featuring AMRH Leaders on the First Continental Listing of Medicinal Products Assessed by African Regulators IPQ Monthly Update – February 2025 in Review Week Ending April 4, 2025: Featuring EMA’s Rojo on Combination Product Lifecycle Expectations Week Ending March 28, 2025: Featuring Global Regulatory Panel on Convergence, Reliance, Collaboration, Access, and Innovation Week Ending March 14, 2025: Featuring Kim Notenboom on WHO’s CMC/GMP Assistance Program IPQ Monthly Update – March 2025 in Review IPQ Monthly Update – January 2025 in Review Week Ending January 17, 2025: Featuring FDA’s Trzeciak on Need for Global Partnerships and Harmonization Excipient/Formulation Challenges for Next-Generation mRNA-LNP Therapeutics Draw IPEC/CRS Workshop Spotlight