Event Type: Industry Conference | Date: March 12, 2018 | Location: Leamington Spa, UK

10.00am - 4.30pm GMT

Title: EU GMP Annex 1 draft : Revision insight Joint PHSS & PQG Conference

Following the revision of EU GMP Annex 1 for Sterile Medicinal product manufacturing the PHSS & PQG are joining together to host a discussion on revision with the regulatory authorities.

The revision of Annex 1 will impact all in sterile medicinal  product manufacturing and those sectors where Annex 1 applies: Advanced therapies and Hospital pharmacy aseptic services.

The MHRA are invited to join discussion with the PHSS & PQG on the impact of Annex 1 revision and discuss focus group comments that are in preparation for submission to the EMA.

The impact of these changes will be discussed, book now to take part and add your comment!

Agenda

Start 10.00am

  • Welcome from Chairman of the PHSS & PQG
  • Key note presentation from Andrew Hopkins MHRA GDMP Expert and Head of EMA/PICS/WHO Annex 1 revision working group with a perspective on changes to the revised Annex 1.
  • Presentation from Ian Symonds GSK Head, Aseptic Strategy and Intelligence, Pharma Ops, Global Functions representing the PHSS Annex 1 Focus group on Comments from the Pharma Industry on the revised draft.
  • Break and Exhibition (16 exhibitors planned).
  • Q&A session with the MHRA.
  • Lunch & Exhibition
  • Afternoon sessions: Topic discussions on aspects of Annex 1 revision. Topic sessions run by PHSS and PQG Facilitators.

Close and Thanks – 4.30pm.

Register