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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

12/03/2018
When: Monday 12th March 2018
10:00 AM
Where: Woodland Grange
Old Milverton Lane
Leamington Spa, Warwickshire  CV32 6RN
United Kingdom
Contact: Tamsin Marshall
+ 44 1793 824254

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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 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: Annex 1 Conference

Start 10.00am –12th March 2018

 

Key note presentation: Regulatory perspective on EU GMP Annex 1 consultation document.


10.00am – 11.00am: Andrew Hopkins MHRA GDMP Expert: Head of EU GMP Annex 1 EMA/PICS/WHO
revision working group.

 

Presentation: Pharma industry perspective on EU GMP Annex 1 consultation document.


11.00am – 12.00pm: Ian Symonds GSK Head, Aseptic Strategy and Intelligence, Pharma Ops, Global
Function representing the PHSS & PQG Annex 1 Focus group preparing comments from the Pharma
Industry on the revised Annex 1 draft/ consultation document.

 

12.15pm – 12.45pm: Overview-listing of PHSS-PQG Comments to be submitted to the EMA presented
by discussion facilitators covering each of the Annex 1 chapters providing an insight to the type and
extent of PHSS-PQG comments.

 

12.45pm – 2.00pm: Lunch break / viewing exhibition / networking

 

2.00pm – 3.15pm: Discussion Session 1.


Facilitators Neil Wayman: AstraZeneca UK, Chairman of PQG: Pharmaceutical Quality Group
and Una Hearty Pfier Ireland: representing the PHSS Annex 1 focus group. Discussion format:

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators
    will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma
    Industry representing the PHSS Annex 1 focus group.

 

3.15pm – 4.30pm: Discussion Session 2.


Facilitators Mike Davies: GSK UK Director, Aseptic Strategy & Intelligence Pharma Ops Global
Functions, Co-leader of PHSS Aseptic processing and Bio-contamination special interest group &
member of PHSS Annex 1 focus group.
James Drinkwater: Chairman of PHSS, F Ziel GmbH Head of GMP Compliance, Co-leader of PHSS
Aseptic processing and Bio-contamination special interest group & PHSS Annex 1 focus group and
member of PQG.

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators
    will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma
    Industry representing the PHSS Annex 1 focus group.

 

Conference Close & Thanks 4.30pm: PHSS & PQG Chairman

 

Click here for current agenda.

 Click here for Annex 1 draft consultation document

 

 

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