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

 Export to Your Calendar 06/02/2018
When: Tuesday, February 6, 2018
9:00 AM
Where: TBC
United Kingdom
Contact: Tamsin Marshall
+ 44 1793 824254


Online registration is available until: 16/01/2018
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Following the revision of EU GMP Annex 1 for Sterile Medicinal product manufacturing the PHSS: Pharmaceutical & Healthcare Society and PQG: Pharmaceutical Quality Group 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 PHSS & PQG Annex 1 focus groups that are collating comments for submission to the EMA.

The Conference will also host exhibitors that have technologies and services that support sterile and therapeutic product manufacturing and aseptic processing.

 

Agenda: Annex 1 Conference

Start 9.30am – Date Early 2018 (TBC)

 

·      Welcome from Chairman of the PHSS & PQG

·      Key note presentation from regulatory authority with a perspective on changes to the revised Annex 1.

·      Presentation from representative from the PHSS & PQG Annex 1 Focus group on Comments from the Pharma Industry on the revised draft.

·      Break and Exhibition (20 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.

 

Click here for current agenda.

 

 

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