With the ongoing Covid-19 situation, the organisers of Making Pharmaceuticals have reluctantly decided not to go ahead with the rearranged dates of 26/27 October 2020, but will now not hold a physical event at the Ricoh Arena until July 2021. However, a series of webinars will now be arranged. Keep an eye on the Making Pharmaceuticals website for further details. PQG will plan to attend the new dates and are looking into options for presenting webinars.
The European Commission has published the long-awaited draft Annex 21 on Importation of medicinal products. This is now open for stakeholder consultation until 20-Jun-2020. If you would like to feed comments in via PQG, then please email webmaster@pqg.org by end April.
The document is only short (140 lines). It focusses on the action of physically bringing product from outside the EEA/EU into the customs territory of an EU/EEA state. Imported dosage forms and intermediates which undergo further manufacturing operations are included within scope. Medicinal products which enter EU/EEA for export only and which are not processed or released for the EU/EEA market are out of scope. It is not explicit about whether Investigational Medicinal Products are in scope or not, but there is reference in one place to the Clinical Trial Authorisation. Responsibilities of the Marketing Authorisation Holder, Manufacturing/Importation Authorisation Holder and the Qualified Person are highlighted.
Welcome to the new PQG website!
We are excited about this development which we hope is a step towards making the site an even more valuable resource for our members. The site is now adaptable to optimise usage whether you are on a PC, tablet or phone. The new Blog functionality and interfaces with social media accounts will mean that the content is far more dynamic than in the past. The key features from the old site are still there, so please check out the Shop and the Events page.
Many thanks to Lloyd and Tom at Futuresys for their work on this and special thanks to Sarah, the PQG administrator, who has been very busy testing the functionality and populating the pages.
… CANCELLED
Due to the developing coronavirus situation, we have made the decision to cancel the AGM and 23rd annual discussion meeting with MHRA, which were due to take place in London on 24-Mar-2020.
We will look to rearrange these as soon as possible.
The AGM papers have still been made available in the Members area on the website and we encourage you to look at these and email chairman@pqg.org if you have any questions.
We will work with MHRA to try to provide written answers to questions submitted as soon as possible.
Another fully booked and well received evening workshop was held on 25th February covering the various aspects of Effective Change Management. The event was held at the modern and well equipped ETC venues in London. After a hot meal and some networking, the event kicked off and was co-hosted by John Nesnas, Damian Larrington and Andrew Lovell. The attendees varied in background and experience, from those who are new to their Quality role to others who had decades of experience but were using the event as a continuous development and networking opportunity. It was great to see a number of familiar faces from previous evening workshops. The topics covered included the relevant regulatory requirements, aspects of effective change management, common mistakes and regulatory findings. Practice based questions were discussed throughout with case studies at the end that allowed the attendees to put their learning into practice and to share experiences with their colleagues. Watch out for details of the next event.
A revised version of this annex has been released for limited consultation and may be found here (PQG member log in required).
PQG is not one of the limited organisations able to provide feedback on this consultation, but have teamed up with PHSS to enable members to do so.
If you have any comments on this document, please use this form (PQG member log in required) and email it to webmaster@pqg.org as soon as possible and no later than 20-Mar-2020.