Senior Managing Director, FTI Consulting
FTI Technology Senior Managing Director Rena Verma recently attended the 17th annual Pharmaceutical Compliance Congress. We asked Rena to share the insights she gathered from fellow risk and compliance experts, and her observations on the key issues facing the pharmaceutical industry.
The new environment driven by COVID-19 has created unexpected and increased risks for compliance departments within pharmaceutical and healthcare organizations. Many of these center around managing evolving regulations and an increasing data footprint. Specifically, three common challenges are:
Let’s break this into two categories: data privacy compliance and compliance monitoring.
To address these challenges, legal, compliance and IT departments can take the following steps:
AI and analytics can augment existing data with insights to reveal abnormal behavioral patterns (such as emails being sent during off-hours) that warrant further exploration. The idea is to recognize patterns that emerge from all of the organization’s data (chat messages, email, voice recordings, structured databases, public records, etc.) and not depend on reactive alerts. Another benefit of this technology is to identify patterns and signals within datasets too large for human review. Some tools can also identify industry-specific high-risk behavior, but these are more advanced and typically require guidance from experts to effectively deploy.
Technology adoption and innovation are going to keep growing and evolving to keep up with the driving forces associated with today’s environment. One of the best things compliance teams can do is stay abreast of the changes on both the regulatory and technical fronts, and be ready to shift when needed.