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Current Events

Live Online – Qualified Person Education Course

30 June - 1 July 2021


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IMP Working Group Members Area


Document and track your personal development - with the Continuous Professional Development (CPD) Documentation Template

To access the template for documenting and tracking your past and ongoing activities, please go here.

After filling out the form, you will be able to create and print out a PDF file.

IMP Working Group

History:

Already at the first QP Forum 2006 in Prague Annemiek Stijnen and Martine Tratsaert proposed to establish a Working Group 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.

During the Pre-Conference Workshop at the 2008 Forum in Munich, the following topics were discussed: Interphase GMP-GCP, The role of the hospital pharmacist and Phase 1 minimal requirements.

Today, the IMP Working Group is a well-established "sub-organisation" and its Pre-Conference Workshop a well-known part of this annual QP Association event. The workshop is also facilitated as an annual meeting of the IMP Working Group and provides a very good opportunity for networking and cultivating personal contacts.

Objectives:

  • Exchange of experience

  • Exchange of ideas/insights

  • Discuss interpretation of regulatory guidance

  • Discuss difficulties encountered in daily QP practice and how to solve them

  • Inform each other on country specific items (import, export, views of regulatory authorities)

  • Any other goals that the members may bring in

  • Try to influence HA by providing valuable input to new legislation

  • Installing core team dealing with new legislation would be an asset.

Current Activities:

Click on the corresponding link to get more information about the current activities of the IMP Working Group.

In December 2020 the WHO issued two working documents for public consultation: Good Manufacturing Practices for Investigational Products and Good Practices for Research and Development Facilities. The IMP Group wants to provide the WHO with two consolidated documents from IMP QPs. Below you therefore find the commmenting templates for these two working documents. The group would appreciate it if you took the time to complete and return your comments by 15 December to IMPQP@qp-association.eu.

Further Activities

Management and Administration:

The IMP Working Group is led by:
Dr Susanne Ding, Boehringer Ingelheim, Germany
Niina Taylor, Pfizer, UK
Patryk Jegorow, Takeda, Ireland
Brenda van Assche, Janssen Pharmaceutica NV, Belgium
It is with our deepest sadness to inform you of the sudden and unexpected passing of our dear colleague and friend Justin Barry. Justin was a highly valued member of the IMP QP Board since 2013, representing the voice of a Qualified Person from a small biotech company.
We will remember Justin being always in good mood and humor, reflective, inspiring, outstandingly helpful and accommodating, always available when needed. We are deeply grateful for the time together.
Administration work is provided by the EQPA Secretary. To become member of the IMP Working Group please contact us via eMail: info@qp-association.eu
Please note that membership in this group will be granted to Members of the QP Association only.