Pharmaceutical

The Pharmaceutical industries are among the most heavily regulated in the world. The regulatory environment is continuously changing in response to the effects of globalisation and harmonisation, emerging markets, increasing complexity of disease targets, introduction of new technologies and the rising sophistication and demands of both patients and regulators.

Rapid changes in the pharmaceutical industry call for a compliance upgrade. Moreover, regulators’ capabilities to identify risks and possible bad behaviors are evolving, internal pressure to cut costs and do more with less is intensifying. Companies also face challenges posed by a fast-changing patchwork of data privacy regulations and information security.

Adoption of digital technologies such as automation and machine learning can help compliance maintain its position as a strategic partner to the business. The time to invest in digital transformation is now; every company can take steps today to modernize its compliance operations regardless of where it is on the digital maturity continuum.

Pharmaceutical companies now have access to unprecedented amounts of data. Advancements in AI and data analytics technologies can not only help detect existing risks, but also help predict and prevent future ones — thus enabling the compliance function to take a more proactive approach. Data is also crucial to address many other compliance issues, such as reporting, measuring training programs and vendor due diligence.

Adding to these risks is the increase in data protection and privacy regulations around the world, such as the European Union’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA). All of these carry stringent requirements as to how data should be secured, accessed, stored and used. And their noncompliance creates the risk of hefty fines, reputational damage and potential disruption to the business.