Great industry conferences are often the result of a combination of factors: good planning, strong speakers, with real depth in expertise and a passion for their topic, and attendees/delegates with great questions. When all three line up in one event, all participants gain tremendous value from the presentations and the following discussions.
Q2 presented two such opportunities on the Pharmacovigilance events calendar for ‘the moons to align’, and I was delighted to participate in both. Here are my key takeaways from these events; if you attended either or both of these events, I’d love to hear your thoughts or alternative takeaway topics.
Oracle Industry Connect, 11-13 April 2016 – Orlando
Whilst the keynote sessions broadly cover all industries that Oracle touch, the over-riding message of ‘Cloud’ permeates deeply into the topics for Health Sciences.
Cloud solutions are complementary to global strategies and support scalability, resilience and data security while minimising costs. There is increasing acceptance that ‘Cloud’, if configured appropriately can provide the levels of assurance to meet Pharma companies’ requirements.
Big Data in Pharmacovigilance – Sources of safety data are becoming increasingly diverse but the strength of evidence from the different streams must be understood and taken into consideration prior to evaluation. Clearly the ‘Holy Grail’ is to channel better data for better signal detection. In parallel there is the need for discussion and development to ensure the right tools are available to detect meaningful signals in what can be very high volume, yet rather poorly structured data.
Integrated solutions within Clinical studies – Companies are continuing to expand their focus on integrated offerings that combine Safety databases, signal evaluation and in future, intake tools. One such offering, the Accenture Life Sciences Cloud for R&D enables companies to not only share technology but also to share experiences of implementations.
Addressing the Challenges of Safety Data Collection in Clinical Studies Roundtable – We were delighted to lead this session, joined by so many of our global pharmacovigilance colleagues, as we discussed the specific process challenges faced within a clinical trial setting. We also reviewed recent reports that reflected quality issues in SAE reporting, issues of accuracy & completeness of the reports and ultimately the identification of disagreement on causality assessments between investigators and data-safety monitoring boards. Thank you to all those that joined us in our detailed and frank dialogue.
For more information: View the Roundtable Discussion Summary
World Drug Safety Congress Americas, 20-21 April 2016 – Chicago
Pragmatism in drug safety – the importance of being ‘compliant’ while applying the regulatory framework in a pragmatic and risk-based manner. There is increasing recognition that Regulatory authorities recognise that resources should be applied differentially based on the nature of the products and their stage in the lifecycle.
Patient engagement – how patients can provide unique insights into their conditions, their unmet needs and finally their experience of medicines. This area is not new, but is receiving increasing focus given the range of digital and online tools now available, that enable patients to connect within a disease area or where Pharma companies are engaged in ‘support programs’.
The increasing prominence of Pharmacovigilance at Corporate level – Chief Safety Officers must have ‘a seat at the table’ for strategic Company discussions. Penalties for non-compliance with regulations, whether financial or reputational, are increasingly aggressive. Heads of Safety must be influential at the highest levels in their organisations to ensure that medical, marketing and country organisations are familiar with expectations.
Addressing an evolving drug safety landscape – My session at this event was focused on the evolving landscape that we work within, facing increasing pressures from external sources such as regulatory focus on risk management and inspection scrutiny on non-core areas; in addition to the internal force of aggressive annual growth of adverse event reports within an over-riding environment of cost containment. I presented an overview on current process challenges and my views on how we can move from passive to active pharmacovigilance, by taking a more risk-based approach to drug safety, dependent on the position in the product lifecycle.
For more information: View the WDSC Americas Presentation