European QP Association Developments May through August 2025

Board Developments
An initiative was started to review and improve the QPSHARe database and the Q&As to the QP-Share database.

Surveys
Survey on the EU Clinical Trial Regulation (536/2014) (CTR)
In August 2024 a survey on the EU Clinical Trial Regulation (536/2014) (CTR) was launched by the IMP Working Group to gain a comprehensive overview of how organizations were implementing the new EU CTR framework. The survey results are posted on the website under both 'Members' Surveys' and in the IMP Group's download area. The key findings and insights from the survey were published in the EQPA News (Issue 21, July 2025), highlighting the challenges and strategies employed by various organizations.

Miscellaneous
Press Contact with US Magazine
EQPA is in contact with Prof Debbie Cenzipe (investigative journalist at ProPublica and Professor at Northwestern University Medill School of Journalism in the USA) and some of her students, who are working on an article on possible measures to increase the quality of (imported) generic medicines in the USA. They came up with the role of QP in the EU and how it ensures quality of medicines in the EU. They are now working on a more detailed report with perspectives from different generations of QPs, for example, how more senior and younger QPs view their role. EQPA is supporting this with interview partners (members of the Board and EQPA).

Publications
The new EQPA Newsletter issue has been uploaded to the download section of the members' area with articles on: 

• Remote Certification - Take-aways from legal considerations
• QP Involvement in managing human medicinal Product Shortages
• Medicine Shortages and the European Regulatory Framework: What a QP has to know
• Insights from the Survey on Clinical Trial Regulation (CTR) Experience
• Third country GMP Inspection for Investigational Medicinal Products (at AbbVie): First Experiences and Insights into the Inspection Process