Regulatory Digest

Previous Regulatory Digest Newsletters

• ISPE Regulatory Digest 2023

  

  ISPE Regulatory Digest Q4 2023

  • ISPE President/CEO fireside chat with FDA Commissioner
  • Health Canada on Advanced Manufacturing and Other Trends
  • Review and inspection practices spotlighted at Global Regulatory Town Hall
  • ISPE’s regulatory and quality initiatives deliver conference sessions, articles, and training

  

  ISPE Regulatory Digest Q3 2023

  • EMA Executive Director on the Value of Adaptation, Trust, and Collaboration
  • FDA Office of Quality Surveillance on Quality Management Maturity
  • EMA on International Cooperation, Harmonization, and Reliance in GMP
  • Industry-regulatory discussion panels

  

  ISPE Regulatory Digest Q2 2023

  • Barriers to Innovation: Your Input Requested
  • ISPE Releases Drug Shortages Prevention Model
  • Report on ISPE Work to Support EU HERA
  • ISPE Comments on Draft Guidelines

  

  Regulatory Digest Q1 2023

  • ISPE Launches Initiative on Enabling Global Pharma Innovation
  • Annex 1 Implementation from the Regulators’ Point of View
  • Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires
  • Your Expertise Can Shape Regulation and Guidance

• ISPE Regulatory Digest 2022

  

  Regulatory Digest Q4 2022

  • ISPE’s Advancing Pharmaceutical Quality (APQ) Program Fully Launched
  • ISPE’s APQ Program presented at FDA Advisory Council Meeting on Quality Management Maturity
  • ISPE Highlights Pharma 4.0 at PIC/S 50th Anniversary Event
  • ISPE Holds Regulatory Summit on Modernizing Inspections
  • ISPE Singapore Affiliate Regulatory Panels
  • Regulatory Insights from 2022 ISPE Annual Meeting

  

  Regulatory Digest Q3 2022

  • Are you ready to implement ICH Q9(R1)?
  • ATMP Regulations: Comparison of EudraLex Part IV with PIC/S Annex 2A
  • FDA’s Approach to Advancing Quality Surveillance
  • EMA on Facilitating Innovative Manufacturing
  • Continuous Manufacturing of Drug Substance vs Drug Product
  • ISPE’s Asia-Pacific Regulatory Group Re-established
  • Quality and Regulatory Challenges, Learnings, and Future Opportunities: ISPE 2022 Annual Meeting

  

  Regulatory Digest Q2 2022

  • Regulator/Industry Panels at 2022 ISPE European Annual Conference
  • ICH Q2(R2) and Q14 aim to promote more robust analytical processes, greater ease of switching analytical methods post approval
  • ISPE Helping Industry Prepare to Implement ICH Q9 Revision
  • ISPE Assists Health Canada with ICH Q12 Training
  • ISPE’s Advancing Pharmaceutical Quality (APQ) Program Third Guide Released

  

  Regulatory Digest Q1 2022

  • Industry Study Finds Divergence in Regulators’ Interpretation of ICH Guidance Related to Control Strategies
  • Senior US Pandemic Advisor on Messaging and the Public’s Faith in Pharmaceutical Products
  • Path to a Global Dossier: a glimpse of the future?
  • Global Regulators Discuss Data Integrity and Real-World Evidence
  • ISPE’s Biotechnology Conference and Workshop Featured Several Panel Discussions with Global Regulators

• ISPE Regulatory Digest 2021

  

  Regulatory Digest Q4 2021

  • US FDA and WHO Highlight Agility and Collaboration at 2021 ISPE Annual Meeting & Expo
  • Regulators Answer Industry’s Top Questions at 2021 ISPE Annual Meeting Global Regulatory Town Hall
  • Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

  

  Regulatory Digest Q3 2021

  • Global Regulators and Industry Discuss Shared Responsibility for QRM at ISPE June Summit
  • Expanded Coverage of ISPE’s Summit on Remote/Distance Assessments
  • ISPE’s PQLI® Initiative helps advance new Regulatory and Technology Approaches
  • ISPE’s APQ Program: Management Responsibilities and Review Guide Released
  • ISPE Initiatives Support Supply Chain Resiliency

  

  Regulatory Digest 2021 – Q2

  • Global Regulators Discuss Remote/Distant Assessments, Audits, and Guidance at ISPE Summit
  • ISPE and an Association Group address Annex 1 Implementation Timelines
  • ISPE Commences Study on Business Continuity Planning for Drug Shortage Prevention
  • Integration of QRM and KM Provide Opportunity for Effective Risk Management

  

  Regulatory Digest 2021 – Q1

  • ICH Q12 Implementation Strategies Discussed During Webinar on Challenges and Success of ICH Q12
  • 2020 ISPE Annual Meeting & Expo: How Regulators are Responding to COVID-19’s Impact
  • Regulatory Panel Addresses COVID-19 Challenges
  • Regulators Discuss Distant Assessments During and After COVID-19
  • Singapore Affiliate’s 20th Anniversary Conference
  • ISPE Singapore Affiliate Interviews HSA’s Sia Chong Hock
  • Remote/Distant Assessments, Audits, and Regulatory Guidance
  • FDA Commissioner on Lessons Learned from COVID-19
  • ISPE Participated in DAF ACT Initiative to Support Domestic Manufacturing of API
  • ISPE’s Advancing Pharmaceutical Quality Program Launched
  • Drug Shortages: Looking Forward with Regulator Insight
  • Business Continuity Planning to Prevent Drug Shortages
  • ANVISA training facilitated by ISPE’s Latin America Regulatory Group
  • ISPE’s Regulatory Committees, Working Groups, and Initiatives