Remote/Distant Assessments, Audits, and Regulatory Guidance

Thank You for Making this Virtual Conference a Huge Success!

The 2021 ISPE Global Pharmaceutical Regulatory Summit held on 28 April brought together leaders representing 11 regulatory agencies from around the world to share their knowledge on the challenges and guidance related to remote/distant assessments and audits.

Watch the clip featuring Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA, and Brendan Cuddy, Lead Scientific Officer, European Medicines Agency, during the Regulatory Panel to get a sample of the enlightening discussions.

Look for coverage of the April Summit in the Quarterly ISPE Regulatory Digest eNewsletter. Register for the 2021 ISPE Global Pharmaceutical Regulatory Summit on 16 June which has a similar format and focuses on quality risk management.

Health Authorities Represented at April Summit:

• AEMPS
• AIFA Agenzia Italiana del farmaco
• ANSM Agence nationale de sécurité du médicament et des produits de santé
• European Medicines Agency
• FDA
• Health Products Regulatory Authority (HPRA)
• PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
• Medicines and Healthcare products Regulatory Agency
• Regierungspräsidium Darmstadt
• Russia State Institute of Drugs and Good Practices
• World Health Organization