CBI's Compliance Congress for Life Sciences - Key Insights

FRA Partner Emma Hodges and FRA Associate Director Jenny McVey spoke at CBI's 4th Annual Global Compliance Congress for Life Sciences on the panel Streamlining the Investigation Process for Better Results, discussing best practices for developing an investigation framework from start to finish.

A common theme at the conference was culture and tying compliance into culture.

Key insights from the conference included:

- The corporate culture of ethics should continue to be cultivated and woven as part of an overall compliance program. It is imperative to align the compliance strategy with business strategy in order to implement change. As such, culture should be measured with the same stringency as assessing a compliance program.

- Due to the nature of life science business operations, the risk of bribery and corruption are high. Considering recent FCPA and ABAC actions, life science companies need to re-visit their due diligence programs and enhance areas that are especially vulnerable.

- Although social media provides an opportunity for life science companies to engage with stakeholders, the landscape presents a unique set of challenges on how to promote, communicate and inform patients, HCPs, and the public. Compliance functions should set clear internal policies and compliance strategy around social media. Additionally, considering that the EU is on the cusp of GDPR, privacy concerns and adherence to local compliance regulations should be addressed.

- Third-party compliance programs should be evaluated with robust monitoring and documentation in place. One key area of focus should be around third-party sub-contractors and the standards and practices that they adhere to.

- Considering the EU is on the cusp of GDPR, companies should continue to prepare for May 2018 by setting up vendors and contracts to cover data controller and processor arrangements, understand the highest risk areas within the organization and consider implementing a systems approach to ensure compliance with the regulations.

Backed by 14 years of providing an interactive, senior-level forum for Chief Compliance Officers and their teams, CBI's 4th Annual Global Compliance Congress for Life Sciences offers the opportunity for life sciences companies to come together, share ideas, network and learn from one another on how to implement and maintain global compliance programs and mitigate risk. The Congress covers topics such as global transparency, FMV, third-party due diligence and many other issues faced by the industry.