Broughton's Head of Regulatory Affairs, Lloyd Smart, has recently published an article with the leading sector publication, PharmTech.
Pharmaceuticals
Broughton's Head of Regulatory Affairs, Lloyd Smart, and Technical Sales Administrator, Curtis Gallagher share thoughts on emerging topics following the 27th Annual Pharmacovigilance conference.
The 27th Annual Pharmacovigilance Event hosted by Virtue Insight brought together industry leaders in pharmacovigilance and focused on emerging topics such as the role of Artificial Intelligence (AI) in Pharmacovigilance (PV) and how the sector can evolve following lessons learned from the pandemic.
The major talking point from the event was the impact of the Covid-19 pandemic and its impacts, both immediate and longer-term, on the PV sector. Sakharam Garale, the Founder and CEO of Renovare Healthcare, highlighted the negative effect the pandemic had on clinical trials, with over 1,100 trials being disrupted or suspended in the US and EU alone. In response to the pandemic many governments, including the UK, introduced some welcome flexibility, for example, relaxation of risk minimization measures, flexibility in reporting requirements for Individual Case Safety Reports (ICSRs) and postponement of other pharmacovigilance requirements including waiving Periodic Safety Update Reports (PSURs) in certain instances. Sakharam also discussed that the growth of the PV market is anticipated to reach a CAGR of over 7.3% until at least 2027, with the increasing acceptance of outsourced PV services expected to stimulate the market expansion. The pandemic did highlight the importance of PV within the drug lifecycle, particularly in post-market signal detection. In a panel discussion Maria Maddalena Lino, the Safety Risk Lead Director of Pfizer shared that the company had received over 2 million adverse drug reactions as a result of their Covid-19 vaccine, showing a marked increase in overall detections in previous years.
Another topic widely discussed was the emergence of AI in PV and the digitalization of processes to help streamline PV. Nicole Baker, the co-founder of BioLogit discussed the potential for AI to improve global and local medical literature monitoring. AI integrated workflows can help save companies up to 70% in workload versus manual workstreams, streamlining processes such as digesting large volumes of article information and tracking the latest updates in medical and regulatory affairs.
On a global scale, as we hopefully begin to transition back to some kind of “new” normal we are already witnessing an upturn in clinical trials. There will be some areas of PV that have changed forever and others where the integration of alternative approaches, especially AI, will be fascinating to watch throughout 2022
To identify your next steps, contact us to book a meeting with our regulatory services team. If you’d like to learn more about regulatory pathways and how they create new business opportunities for forward-looking companies then read our recent Regulatory Digest below:
Can we help you?
Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; creating a smoke-free future.
Book a meeting with us today to discuss your requirements.
