PHSS https://validator.w3.org/feed/docs/rss2.html Public call for expression of interest for experts to become members of EMA’s Scientific Advisory Group on immune and inflammatory diseases – Deadline: 17 September 2025 Home Impact Statement – EDQM – New control of ethylene glycol and diethylene glycol in Macrogols (1444) published for comment Impact Statement – USFDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight PHSS August 2026 Regulatory Update PHSS Clarity In GMP – Assurance Of Sterility For Container Closure PHSS Biological Indicators (BIs) for applications in VHP/vH202 bio-decontamination PHSS June Regulatory Update 2026 Bio-contamination Characterisation, risk profiling, control, monitoring and deviation management – PHSS Technical Monograph No 20 Bio-Contamination Restricted Access Barrier Systems (RABS) Definition, Classification, Specification and Use for Aseptic and Related Processing – PHSS Technical Monograph No 15 PHSS Clarity In GMP – Pharmaceutical Isolator Leak Integrity Classes and Leak Rates PHSS Clarity In GMP – Qualification Of No-Touch-Transfer NTT Supporting Partners PHSS July 2026 Regulatory Update PHSS Clarity In GMP Guidance – Cleanroom Airflow Definitions PHSS Contamination Control Strategy Guidance Pack New PHSS Publication Released: Biological Indicators (BIs) for Applications in VHP/vH₂O₂ Bio-Decontamination Refrigeration in Freeze Dryers – PS (PHSS) Technical Monograph No.12 Announcement: PHSS Training for USA FDA on Airflow Visualisation. Leak Testing of Freeze Dryers – PS (PHSS) Technical Monograph No.7 The Cleaning of Freeze Dryers – PHSS Technical Monograph No.13 Decommissioning with GMP – PHSS Technical Monograph No. 18 Restricted Access Barrier Systems (RABS) Definition, Classification, Specification and Use for Aseptic and Related Processing – PHSS Technical Monograph No 15 – PDF E-Book Integrity Testing of Freeze Dryer Inlet Filters -PHSS Technical Monograph No.8 (Revised 2008) Quality Rules – In Packaging Quality Rules – A Short Guide To GMP PHSS Aseptic Processing Workshop 2026 Training Recorded Impact Statement -EMA Breakthrough medical devices: information session PHSS April 2026 Regulatory Update PHSS Announcement – Protective Airflows, including First Air protection applied in Aseptic manufacturing for Annex 1 compliance Advances In Cleanroom Technology – By William Whyte EMA communication: First issue of the new ‘EMA Industry Highlights’ newsletter coming at the end of March! EMA communication: EMA’s biennial report on stakeholder engagement activities 2024-2025 Pharmaceutical quality system (PQS) effectiveness pilot project EMA communication: new communication tool on vaccines – meningococcal B Vaccine Essential PHSS March 2026 Regulatory Update PS Technical Monograph No.14 – PHSS/ S2C2 – Risk Management of Contamination (RMC) During Manufacturing Operations in Cleanrooms Our Team PHSS QRM and PRM for Annex 1 compliance webinar recording 2026 EMA communication: EMA welcomes political agreement on new EU pharmaceutical legislation PHSS May Regulatory Update 2026 PHSS November 2025 Regulatory Update Impact Statement – Recent changes to the EU / US Mutual Recognition Agreement LIVE BROADCAST: Public webinar: Shortages: Putting Patients First – 4th November 2025 (14:00-16:00 CEST) Impact Statement – Mila to Millions: A New Era of Individualized Medicines  (MHRA Guest Blog) PHSS February Regulatory Update 2026 News PHSS December Regulatory Update 2025 EMA consultation: Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development PHSS January Regulatory Update 2026