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Updated: Oct 9

PHSS News | Open Access | Published 8th October 2025


PHSS News


We recently hosted the PHSS Annual Conference, kindly Sponsored by bioMérieux, on 16th & 17th September,


The PHSS Annual Conference, held on September 16 and 17, 2025, was an event blending technical innovation, regulatory expertise, and collaborative networking. The program began with a warm welcome by Alf Penfold and set the scene for several engaging presentations and discussions, offering extensive coverage of the latest developments in manufacturing, quality assurance, and regulatory science.

One of the standout opportunities of the conference was the afternoon tour sponsored by bioMérieux, of the Cell and Gene Therapy Catapult in Stevenage, thoughtfully hosted by Alex Templar, Deven Gajjar, and their dedicated team. This tour granted delegates a unique, behind-the-scenes glimpse into leading-edge advanced therapy manufacturing facilities, spotlighting how innovative technologies and multidisciplinary knowledge are shaping the future of cell and gene therapy. The hosts shared operational insights, demonstrated processes, and encouraged knowledge exchange between industry, academia, and regulators. Such hands-on learning proved informative for professional growth and cross-sector understanding.

On the evening of the first day, delegates enjoyed a well-attended networking dinner, generously sponsored by bioMérieux. Started by a presentation by bioMérieux.

The technical program on the main conference day was robust and diverse. Kevin O’Donnell, PhD, Market Compliance Manager at the HPRA, opened the agenda with a focus on “ICH Q9R1: A Framework for Demonstrating PQS Effectiveness?”, unpacking regulatory changes and their implications for pharmaceutical quality systems. Tracy Moore, Founder and CEO of TM Pharma Group Ltd, delivered insights on “Design, Control and Monitoring—What is the Monitoring Telling You?”, reviewing Annex 1 expectations, and technical strategies for contamination prevention and monitoring. Presentation provided by Tishwant Kanwarjit of Autolus, was next and presented “From Research to Commercial: ATMP Success Factors.” Deven Gajjar from the Cell and Gene Therapy Catapult contributed a compelling session on integrating quality control considerations early into the advanced therapy development lifecycle, emphasizing collaborative manufacturing and regulatory alignment.

Dr. Hussein Bachir, Scientist GMP Compliance at Franz Ziel GmbH, explored “Effective Airflow Visualization Techniques,” covering best practices in airflow control and environmental monitoring. Laurent Leblanc, Senior R&D Manager at bioMérieux, showcased the potential of automation for environmental monitoring, demonstrating how automated techniques can strengthen data integrity and laboratory outcomes. Zeeshan Siddiqui of The London Clinic transported the audience through the regulatory and practical challenges in “WDA(H)—The Licensing Journey: A Pharmacy and Stem Cell Lab Collaboration.” Alf Penfold, representing the PHSS Management Committee and PM Group, provided critical updates on PHSS technical monographs and guidance development, outlining sector priorities and supporting tools.


The conference also championed new talent: student award presentations from Mr. Shom Chatterjee (SyriMed PQ UCL) and Ms. Thriveni Nagireddy (Viatris PQ UCL) further reinforced the value of developing the next generation of industry leaders.


Thank you to our key sponsor bioMerieux, thank you to Catapult for hosting the facility tour on 16th, the speakers all our exhibitors, the delegates and of course the PHSS Office for all the preparation in delivering a fantastic and engaging event.


Some feedback received so far:

“Good to attend a well-focussed conference, many can be so broad that detail isn’t really discussed.”

“I really enjoyed the networking opportunities and the engaging discussion during the session. The venue was excellent and well organised, and the speakers provided valuable insights.”

“The size and format of the event allow for really good networking and a great opportunity to learn. The talks are always focussed on detailed information sharing with almost no sales content and that is fantastic.”


Staying ahead:

Keep up to date with all the essential regulatory update via the PHSS Monthly Regulatory Update, this is free to members and saves you time and effort by scanning, analysing, and compiling essential changes. From GMP transformations to global shifts in regulatory focus, the PHSS Monthly Regulatory Update ensures that you have the insights you need when you need them.


Staying connected:

We are busy planning the next events to bring to our membership, providing invaluable insights and learning opportunities. Engage with Key opinion leaders and Subject Matter Experts.



Thank you as always to all our valued members, partners, and industry collaborations for your invaluable support.



Best wishes to you all


Jenni Tranter,

PHSS Chair

September 2025





 
 
 

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