Please note, the programme is subject to change. For the most up to date, detailed programme, please see the website/app when available.
PRE-CONFERENCE - TUESDAY 4 NOVEMBER 2025 TH
THE WELCOME RECEPTION
Start your conference experience with our Welcome Reception in the exhibitor area. Enjoy drinks and informal food while meeting fellow delegates, exhibitors, and speakers in a relaxed setting
Build connections, share ideas, and set the stage for meaningful discussions throughout the conference
Also featuring: VIP area (invite only), first-conference/new RQA member meet-up at the RQA stand.
Plenary Session
08.30
DAY 1 - WEDNESDAY 5 NOVEMBER 2025 TH
RQA AND SPONSOR OPENING
MATT JONES (RQA CHAIR), GLENE SANDOM (RQA VICE CHAIR) AND PLATINUM SPONSOR (HONEYWELL LIFE SCIENCES)
SESSION INTERVAL
KEYNOTE SPEAKER - PROFITS, PRAGMATISM, AND THE POSSIBILITIES OF POSSESSING ‘OTHER EYES’ BILL BELLOWS, INTHINKING SERVICES
The value of profits as an ingredient for organisations to sustain and develop their operations is undeniable Thinking beyond the design and development of the next iProduct, profits allow for improvements to current products, not to mention needed technology upgrades, employee development, and dividends for shareholders. But, do organisations solely exist to earn profits or meet financial goals, or, are their profits the result of how well they invest their resources, from innovation to revenue and equipment, and then deliver new and improved products or services? W Edwards Deming saw profits as the result of a well-designed and managed organisation Contrary to the dominance of the prevailing style of management, Dr Deming saw vast possibilities for individuals to work together, possessing ‘other eyes. ’ Through a thought-provoking question and answer session, attendees will be asked to question the context of their own observations and the resulting pragmatism of efforts to improve teamwork in their organisations
INSPECTION READINESS
JOIN REGULATORS TO DISCUSS HOW PRAGMATISM OVER PERFECTION CAN FIT INTO YOUR INSPECTION READINESS APPROACHES
Please note, the programme is subject to change. For the most up to date, detailed programme, please see the website/app when available.
9.00 ‘ZOOM, TRANSLATE, REPEAT’: SURVIVING (AND THRIVING IN) REMOTE PMDA COMBINED GCP AND STABILITY DATA INSPECTIONS FOR BIOSIMILARS, TOMAZ VAUPOTIC 9.45 SITE-LEVEL QUALITY ISSUES: FROM KNOWLEDGE GAPS TO MALICIOUS NONCOMPLIANCE, FLORIAN ADRAGNA 11.00
Please note, the programme is subject to change. For the most up to date, detailed programme, please see the website/app when available.
DAY 2 - THURSDAY 6 NOVEMBER 2025 TH STREAM 4
Sponsor Sessions
9.00
9.45
NOTHING IS PERFECT - WHEN CHASING PERFECTION GOES WRONG, DORIS RAITH, HONEYWELL LIFE SCIENCES
PRAGMATIC DIGITAL TRANSFORMATION: RISK-BASED APPROACHES TO IT SYSTEMS VALIDATION, DATA GOVERNANCE, AND AI IMPLEMENTATION, MATT JONES, DQA
10.30 NETWORKING BREAK
Regulations - Pragmatism or Perfection?
QUALITY OVERSIGHT IN NON-INTERVENTIONAL STUDIES: A COLLABORATION PROJECT BY THE RQA AND THE JSQA, TAMAI SHOUKO, ALISON ALLEN
BRIDGING THE GAP: ADVANCING GLP STANDARDS TO PROPEL AFRICA'S PHARMACEUTICAL INNOVATIONS, THULILE VAN WYK
12.30 NETWORKING BREAK AND LUNCH
WORKSHOP: PRAGMATIC DATA INTEGRITY: NAVIGATING CHALLENGES IN VETERINARY STUDIES
15.00 NETWORKING BREAK
WORKSHOP: FIGHT THE FEAR: LABORATORY AUDITS AND FIT-FOR-PURPOSE METHOD VALIDATIONS, SANDRINE BONGIOVANNI AND THE RESEARCH PRACTICE GROUP
PLENARY SESSION: ROUND-TABLE DISCUSSIONS
Please note, the programme is subject to change. For the most up to date, detailed programme, please see the website/app when available.
DAY 3 FRIDAY 7 NOVEMBER 2025 TH COMMITTEE-LED SESSIONS
8.00 GCP PANEL: CHALLENGING AND HOT TOPIC Q&A’S – YOUR GCP QUESTIONS ANSWERED!
SIGNIFICANT CHANGES IN PV IN 2025
JANA HYANKOVA
PROPORTIONAL RESPONSE TO INSPECTION HOT TOPICS WITH THE GLP COMMITTEE AND MHRA
SCENARIOS WILL COVER (EXACT SCENARIOS TO BE CONFIRMED): EFFECTIVE AND PROPORTIONAL CAPA, ELECTRONIC ARCHIVING, TEST ITEM CHARACTERISATION AND STABILITY, EQUIPMENT QUALIFICATION. RICHARD CROSSLAND, SHONA ROSS AND CATE OVINGTON, GLP COMMITTEE
E-ARCHIVES IN THE MIDST OF THE GENAI GOLDRUSH: THE IMPORTANCE OF GXP DATA INTEGRITY FOR COMPLIANCE AND
Please note, the programme is subject to change. For the most up to date, detailed programme, please see the website/app when available.
DAY 3 FRIDAY 7 NOVEMBER 2025 TH
COMMITTEE-LED SESSIONS
TIME TBC IMPACT OF ICH E6 R3 ON VETERINARY SPONSOR OVERSIGHT AND GOVERNANCELOOKING AT IMPLEMENTATION BY A SPONSOR (E.G. BY INSPECTION OF A CRO)
HELEN HARLOW
TIME TBC INSPECTION PREPARATION BY CRO TBC
TIME TBC VICH GCP EXPERIENCES (BY A SPONSOR AUDITED THIS YEAR BY THE FRENCH AUTHORITIES)
J-P LEUILLIER
TIME TBC FDA INSPECTIONS OF VETERINARY SPONSORS IN EUROPE
10.30 NETWORKING BREAK
11.00 REVISION OF E6: INSIGHTS FROM EUROPEAN MEMBERS WHO HELPED DRAFT IT, PETER TWOMEY, EMA AND REBECCA STANBROOK, NOVARTIS
Explaining measures to bring about harmonisations within the EU and exchange of information with global partners and how EMA are ensuring inspectors are inspecting against the spirit of proportionality/risk-based approaches brought about by ICH E6 R3
12.00
KEYNOTE: BEYOND THE PERFECT PILL: HOW PRAGMATIC QUALITY WILL SAVE MORE LIVES, FABRIZIO MANIGLIO, HONEYWELL LIFE SCIENCES
The life sciences industry stands at a crossroads While we ' ve spent decades perfecting our quality systems, patients continue to wait years for treatments, critical therapies remain economically unviable, and breakthrough innovations stall in regulatory limbo What if our pursuit of the ‘perfect pill’ is preventing us from delivering the medicines that matter most? This keynote will challenge conventional thinking about quality in life sciences, exploring how a pragmatic approach one that prioritises patient outcomes over procedural perfection is already transforming the industry. We'll explore how pragmatic quality frameworks are accelerating time-to-market, reducing costs, and most importantly, getting life-saving treatments to patients faster. We'll also look ahead to 2030 and beyond, where continuous manufacturing, digital twins, and predictive quality systems will make today's batch-andrelease paradigms seem as outdated as bloodletting The future belongs to organisations brave enough to ask not "Is it perfect?" but "Will it help?" Join us as we explore how embracing imperfection might just be the key to saving more lives
12.50 - 13.00 CONFERENCE CLOSING REMARKS