Regulatory Engagement

ISPE provides a neutral environment organization through which industry and global health organizations can work together to enhance efficiency, product quality, and patient health.

More than 190 regulators from 15 countries have participated as speakers, facilitators, panelists, and delegates in ISPE events in Europe, Indonesia, Japan, Singapore, and the US
  • Drug Shortages
    • Ongoing communication with USFDA drug shortages team regarding ISPE’s activities, publications and tools on drug shortages causes and prevention.
    • ISPE’s Report on the ISPE Drug Shortages Survey is cited in FDA's Strategic Plan for Preventing and Mitigating Drug Shortages.
    • Ongoing communication with EMA as a participant in EMA invitation-only workshops; moderated an Inter-association drug shortages task force with members from six European Health Authorities to deliver a collaborative plan for the prevention of drug shortages to EMA.
  • Post-Approval Change Process
    • At the request of USFDA, ISPE researched the timeframes for upgrading facilities and equipment, one of the causes of drug shortages identified in the Drug Shortages Survey.
  • Quality Metrics
    • Ongoing communication with USFDA Quality Metrics team thought meetings, workshops, and conferences to provide data-driven recommendations for effective measures of product quality, site operations, and corporate culture. (Ongoing)
  • Training for Regulators by ISPE
    • Biologic Products and Biosimilars (2017)
      • Training attended by 35 members of the Turkish Medicines and Medical Devices Agency via videoconference. Encompassed biologic product development and regulatory procedures in the US and Europe; Biosimilar product development, manufacturing strategies, and approval case studies.
    • Quality Risk Management and QbD Training for MHRA Inspectors (2013 – 2014)
      • An ISPE team delivered on-site training to more than 80 MHRA assessors and inspectors to demonstrate the implementation and highlight the differences when companies use integrated science- and risk-based approaches described in ICH Q8, Q9, Q10 and Q11.
    • Quality Risk Management Workshop for FDA (2015 – 2016)
      • A cross-industry team from nine companies under RCC auspices and with FDA collaboration conducted an interactive workshop for more than 50 FDA to improve alignment on expectations for the application of QRM principles so that industry and FDA resources may be more efficiently utilized during regulatory reviews, inspections, and post-approval change management.
    • Quality System Requirements for GMP Inspectorates (2014)
      • A training workshop related to Quality System requirements for GMP inspectorates was held in cooperation with China’s Centre for Food & Drug Inspection, China Centre for Food and Drug International Exchange, and PIC/S for approximately 100 heads and quality managers of the provincial FDI’s throughout China as well as officers from FDI.