PHSS Annual Conference in association with UCL Q3P

UCL School of Pharmacy, London
From Date: 
Friday, 11 September, 2015
End Date: 
Friday, 11 September, 2015


Impact of changes in GMP regulations including Annex 1 & ISO standard revisions.

This important PHSS – UCL Q3P conference considers the impact of GMP regulation changes, including Annex 1, 15, 16 and EU GMP (Orange guide) chapters 3, 5, 8 together with ISO 14644 – 1 and 2 revisions.

The industry and healthcare (pharmacies) involved in manufacture of both Sterile and non-sterile products that need to conform to GMP, are more challenged than ever in an environment with changing regulatory requirements based on science and risk.

The anticipated revision to Annex 1, manufacture of sterile medicinal products, is expected to be significant in impact on the industry so it is really important to follow and keep up to date with any changes.

Conversely regulations need to keep in-line with new product types, unique manufacturing challenges often requiring a balance between GMP and containment for contamination and cross contamination control, new technologies and complementary good manufacturing practice.

Following the opening key note presentation from Andrew Hopkins, MHRA Senior inspector and EMA Annex 1 working group, leader a discussion panel of society and association groups involved in recommendations for update will discuss key points considered for Annex 1 revision and the potential impact to the industry.

The discussion panel will include representatives from the PHSS, PDA, A3P, ISPE, R3 Nordic and ECA annex 1 working groups. It is important to keep connected with these revisions and developments so this conference is not one to miss.

The Conference is free of charge to all PHSS members, non-members simply need to join the PHSS at a nominal fee providing access to the conference and many other membership advantages. 


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