Insights from ISPE GAMP In-Person event, Wednesday, 31st May 2023
The Odyssey VC team were delighted to attend the ISPE GAMP In-Person event, “Approaches to New Technologies in Life Sciences”, where it was great to meet so many of our colleagues in the Life Sciences industry. After some lunch and initial networking, the day began with an enthusiastic introduction from Michael Schofield, Chairman of the ISPE Ireland Affiliate, where he spoke of his pleasure in bringing the ISPE community together to discuss and exchange ideas on approaches to new technologies in life sciences.
The first speaker of the day was Steven Duggan, VP of Terawe Corporation, on the topic of ‘Demystifying AI’. The aim of Steven’s presentation was to counter the ‘fear, terror and confusion’ around Artificial Intelligence and Machine Learning. He noted that the pharmaceutical industry has been very slow to come around to these ideas but gave the examples of how disruptive technologies pioneered by companies like Uber and Netflix changed the face of their entire industries. This presentation resonated with Odyssey VC as we are advocates for the adoption of new technologies in life sciences, in particular cloud technologies, and believe that, together with the right practices and controls, there is nothing to fear and much to gain.
‘A failure to imagine what can go wrong may result in catastrophe’ was the key takeaway from Andy O’Connor’s presentation titled ‘ICH Q9 R1 – Enabling a CSA approach to GxP IT Compliance.’ Andy, who is a director with ERA Sciences, fleshed out how risk-based decision making is made every day and delved into hazards from a process perspective. He provided a real–world example of how a risk–based approach was able to reduce testing by 71% and save time for the customer. It is great to be provided with real-world data that demonstrates the enormous efficiencies that can be gained through the adoption of new methodologies and technologies.
Next up, Ray Murphy of Boston Scientific discussed his topic of “Critical Thinking and the CSA Movement – Rethinking Your Approach to Technology.” He pointed out that CSA came about due to a much-needed shift from a focus of just getting through audits and nicely summarised CSA by stating it’s just “CSV with a bit of common sense.” He went on to break down the various types of testing (Ad – Hoc Testing, Unscripted Testing and Scripted Testing) and how they match up with the various risk features (High, Medium and Low). Critical thinking was also a key subject during Ray’s presentation, stating it should be at the forefront for the Life Sciences industry.
After a short break to network, Stan O’Neill, Compliance Group was the final speaker of the day with his presentation on ‘Regulatory Aspects and Inspections of Computerised Systems.’ Stan’s aim was to offer the audience an opportunity to view inspections from the ‘lens of the regulator.’ He pointed out the importance of the soft skills during an inspection, offering an interactive example on how our minds work to a series of questions. A significant point that stood out to the Odyssey VC team was the importance of audit trails and how ‘inspections are for consumer confidence’. Odyssey VC have long since understood the importance of audit trails and the need to provide transparency to the consumer by ensuring GxP activity is being tracked and reported accurately. That is why Odyssey VC is developing solutions to help automate regulatory activities, such as audit trail reviews, allowing for consistent and reliable reporting of GxP activities.
The day closed with a panel discussion involving the four aforementioned speakers, as well as Eddie Ryan, Chief Digital Officer of aCGT Vector and Sam Andrews, Director IT Governance SDLC & Methods of Novartis. The panel touched on a wide variety of topics including regulation around data integrity, the CSA focus on Medical Devices and notably a view by some in the industry even still, that the risk of change may be greater than the risk of staying the same.
Team Odyssey VC really enjoyed this engaging and extremely informative in-person event – thank you to the ISPE Ireland GAMP organizing committee, speakers, fellow attendees and sponsors.
If you would like to find out more about how Odyssey VC can help support your compliance and regulatory needs, just get in touch and one of our experts will contact you
