Book the date 25 January 2018

Dear Members,

We would like to invite you to participate to the second session of EU GMP Annex 1 Working Group meeting to discuss how the future draft of the annex 1 might impact manufacturing processes.
In January 2015, PIC/S and the GMP/GDP Inspectors Working Group (on behalf of the EMA) published a concept paper regarding the update to Annex 1. In recent years, it has become evident that the guidance is not up to date with current technology, the ICH updates, the EU GMP guidance changes, the new ISO 14644 and the change in the European pharmacopeia on production options for Water for Injection.

The aims of the first session of the Working Group Annex 1 were:

the revisions proposed by different entities and organizations

the pro-active change implemented by several industries

the best practices between manufacturers

prepare the next steps for the review of the future draft Annex 1

 

The second session will focus on :

A targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4 which is now available on link

https://ec.europa.eu/health/human-use/quality/developments/pc_2017_12_sterile_medicinal_products_en

 

Book the date 25 January 2018 for the second meeting and come with your comment and feedback to discuss the revision of Annex 1.
More detail on the review process will be sent this beginning of January 2018

 

Date :

Thursday 25th January 2018 

Location :

Bone Therapeutics SA 

rue Auguste Piccard, 37

6041 Gosselies  

Time :

Welcome & Sandwiches
6:00 pm : Starting working session

Topic:

Working Group on the impact of the future draft Annex 1 EU GMP

 

Could we please ask you to confirm your presence by sending back the registration form to This email address is being protected from spambots. You need JavaScript enabled to view it. in order to be sure to have enough places and sandwiches.

Please fill in the online form here

For content info, please contact :

Walid El Azab: This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Hope to see you there

 

Walid El Azab
Secretary of UPIP VAPI