The Pharmaceutical and Healthcare Sciences Society (PHSS) gave their annual conference the title ‘Challenges in Biological & Advanced Medicinal Therapeutic product (ATMP) manufacturing following GMP’ this year. With the revision of Annex 1 being released on the 25th August, shortly before the conference on the 15th September, the conference was much anticipated. Particularly given that MHRA inspector, Richard Parker, was delivering the first presentation.
The event started with a round table discussion the evening before the conference, with questions, opinions and conversation around the new Annex 1. This provided the opportunity to really start to pull apart sections of the new Annex 1, setting up the conference theme for the next day.
This was followed by a cocktail making master class, which went down very well and was a great way for the PHSS to celebrate their 40th anniversary! Especially as it involved speed pouring, where we had to pour without a measure, just using the length of time it took to say a word as a guide for how long to pour the drink for. This was certainly a quick way to break the ice for those who hadn’t met before and was a recipe for good fun. However, I think there may have been the odd thick head in the morning.
The following day was the main conference, and it was packed full of relevant content. To tie in with the PHSS’ 40th anniversary, Gordon Farquharson, from Critical Systems Ltd gave a 40-year insight in how far the industry has come and, in some cases, how it has not moved forward or only taken very small steps.
The keynote from Richard Parker, MHRA Inspector, on implementing Annex 1, had full attendance, as delegates from the industry were keen to understand how to start bridging the gaps.
The other presentations from supply chain, risk assessment of microbial control in ATMP production and the professional skill gaps in the industry, were all fresh perspectives and highly current. More so now that there is a challenge to really marry GMP with ATMPs.
The day ended with another panel discussion - allowing questions to be posed to industry SME’s. I found this to be a great format to allow industry professionals to air their concerns and get perspective and possible guidance to overcome the challenges their facilities are faced with.
An intense, jam-packed day that felt current and applicable. The topics covered at the conference led to some interesting discussions with delegates on our stand on how we, as a supplier, can support the pharma and ATMP industries to close those gaps, with the release of the revision of Annex 1. I feel many left the event stirred (as in enthused) but not shaken (unlike the cocktails of the previous evening) at the prospect of meeting Annex 1 compliance by the deadline of 25th August 2023.
We’re anticipating that the PHSS Annex 1 Discussion forum, which is due to be held on 20th October 2022, will be an event not to be missed for those wanted to get an insight into Annex 1 and its impact.
