About the IMP QP Working Group

The IMP QP Working Group is a well-established "sub-organisation" of more than 2000 Qualified Persons for IMPs - with the objectives

• Represent IMP QPs within the EQPA
• Maintain and grow a strong IMP QP network
• Share and enhance knowledge of IMP QP members by exchanging experiences, challenges, ideas and insights
• Discuss and share interpretation of regulatory guidance
• Identify and promote best practices by benchmarking across industry
• Influence new legislation by providing expert review and feedback to Regulatory Authorities
• Represent the IMP QP role to other stakeholders, e.g., industry colleagues and non-EU regulatory bodies
• Be inclusive and represent a diverse community of IMP QPs, equally taking into consideration different opinions and perspectives

The Group's Pre-Conference Workshop has been a well-known part of the annual European QP Association event for years. The IMP Pre-conference is also facilitated as an annual meeting of the IMP Working Group and provides a very good opportunity for networking and cultivating personal contacts.

Administration work is provided by the EQPA Secretary. Membership in the IMP QP Working Group requires membership in the European QP Association.

History

Already at the first QP Forum 2006 in Prague Annemiek Stijnen and Martine Tratsaert proposed to establish a Working Group for Qualified Persons for Investigational Medicinal Products (IMP) within the European QP Association. The EQPA generally supported this idea and therefore decided to provide a platform for Working Groups and Interest Groups inside the Association.

One year later, at the 2007 QP Forum in Berlin, the IMP Working Group offered a Pre-Conference Workshop on 'Import Requirements for IMPs' and 'Handling of Comparators in Clinical Trials'. This workshop was also the first official meeting of the group. The IMP Working Group also facilitated one of the parallel sessions during the Forum, discussing challenges of 'Being an IMP QP in a global environment’.

In addition, the IMP Working Group contributes to QP Education Courses, and since 2018 is running a full-day IMP QP pre-course session. Representing the IMP QP role to others is furthermore achieved in the US course “European GMPs and the Role of the Qualified Person”.

Over the past years, the following IMP QP Working Group Board members included

• Justin Barry (2012 – 2019) … RIP gone but never forgotten
• Philippe Van der Hofstadt (2012 – 2019)
• Brenda Van Assche (2015 – 2022)
• Niina Taylor (2012 – 2024)

They significantly contributed to the successful development of the IMP QP Working Group.

As part of our mission, we formed task forces to address specific topics led by Sue Mann, Andreas Schwinn, and Claudius Pop. Their very valuable contribution is available in the IMP QP Working Group download area.