Source: BioXconomy

While compliance professionals from Boehringer Ingelheim, Amgen, and AstraZeneca emphasized at a session in Toronto that AI tools are embedded in daily pharma operations, governance has not kept pace and companies are turning to self-regulation to fill the gap. Live polling conducted during the PCC Canada Pharma & MedTech Compliance conference showed 74% of delegates use AI daily and more than 80% expect to increase AI investment, with spending focused on training, risk assessment, monitoring, transparency and disclosure, and data analytics. Delegates reported deploying AI across functions such as document drafting, policy summarization, compliance chatbots and automated monitoring agents, and panelists stressed AI as an augmenting tool rather than a replacement for compliance staff.

Data privacy and security emerged as the primary concern, with nine out of 10 professionals expressing worry, while other risks noted included misinformation (AI hallucinations), governance and oversight challenges, data validity, over-reliance on AI, and confidentiality. Panelists argued that the Canadian regulatory landscape is fragmented — Bill C-27 died during parliamentary prorogation in 2025 — leaving organizations to navigate existing instruments such as PIPEDA, provincial privacy laws, Competition Bureau guidance on AI-related marketing, and Health Canada rules for medical-device AI. Speakers recommended practical governance measures: hands-on review enabling business-compliance dialogue; integrating AI considerations into existing processes like privacy impact assessments and vendor due diligence; adopting principles-based approaches emphasizing transparency, accountability and human oversight; and enabling citizen development while managing risk. Panelists also highlighted partnership across functions and encouraged organizations to build AI literacy through experimentation.