Pharmacy Courses

The challenge of Compliance for Lifesciences Companies

Being part of a highly regulated industry, life sciences companies have a particularly onerous task of complying with a myriad of rules and regulations across all aspects of their business.

The number and complexity of regulatory requirements has increased substantially over recent years and this trend is set to continue in the near term. Responding to this increasingly complex regulatory environment is extremely challenging, especially as non-compliance can have a profound effect on cost, corporate reputations and, ultimately, patients' lives.

Life sciences companies have struggled to address the needs of regulators and remain compliant. Following seven key insights for compliance leaders:

1. Life sciences companies often lack an enterprise-wide view of compliance risk life sciences companies sometimes struggle to understand the full scope of the compliance risk landscape. Obtaining an enterprise-wide view of compliance risk or a single view of overall 'compliance health' is often a challenge.

2. Big Data's role in compliance is often overlooked Life sciences companies tend to analyze and report based on historical data. Applying advanced data analytics techniques could enable companies to identify and quantify - proactively - new and/or emerging risks.

3. The competitive advantages of ethics-driven cultures are being recognized. Companies with mature compliance functions emphasize ethical behaviors, acting with integrity as the norm, as opposed to simply focusing on rules.

4. Companies with the most mature compliance functions will win the talent war. Successful companies will be those that are able to sustain their compliance talent pipeline to meet the increasing demand for, and changing nature of, compliance skills.

5. A lack of dedicated, local compliance resources presents a significant risk for global companies.

6. Major opportunities exist to optimize compliance effectiveness and efficiency. Continuous readiness models are inherently more efficient and would drastically lower overall compliance costs.

7. Leading companies build regulatory engagement into their innovation models. Mature companies build engagement with regulators into their innovation models to develop enhanced regulatory pathways.

By developing strategies to address the above insights, life sciences companies should be able to transform compliance activity from a cost to something that delivers value and sustainable competitive advantage for the organization.

Resource Person: Barbara Pirola

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