ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.

ISPE provides a neutral forum to address and reconcile and global harmonization issues.

Current Regulatory Initiatives and Groups

Advancing Pharmaceutical Quality (APQ) Initiative

ISPE’s Advancing Pharmaceutical Quality Initiative is building industry-for-industry tools and programs to help companies assess and improve their quality operations.

Drug Shortages Initiative

ISPE’s Drug Shortages Initiative is facilitating communication and creating tools to help improve industry’s capability to mitigate and prevent drug shortages.

Product Quality Lifecycle Implementation (PQLI)®

Through PQLI, ISPE assists industry and regulators in advancing manufacturing sciences across the product lifecycle in order to achieve excellence in drug development and in pharmaceutical production.

Regulatory Steering Council (RSC)

The RSC establishes a vision and provides strategic direction to ISPE regulatory initiatives and groups.

Regulatory Quality and Harmonization Committee (RQHC)

The RQHC and its Regional Focus Groups identify and investigate regulatory/quality topics for potential ISPE engagement.

  • Asia-Pacific Regional Focus Group
  • Europe-Middle East-Africa (EMEA) Regional Focus Group
  • Latin America Regional Focus Group
  • North America Regional Focus Group

For more information, contact