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Regulatory Compliance Challenges in a Global Economy

/ June 1, 2016



Regulatory Compliance Challanges

Life sciences companies are facing more compliance challenges now than ever before — from increased regulation, push toward harmonization and security and privacy concerns, to globalization and mergers and acquisitions.

Just as emerging markets now represent an increasing percentage of life sciences industry revenues, the regulatory standards of those markets have become an additional area of concern for regulatory affairs compliance officers. The reliance on technology and cloud-based solutions also present a challenge for complete and consistent compliance.

 

Selecting the Right Compliance Partner

As more life sciences companies shift to a strategic outsourcing model — not only for clinical development and trials, but also for a number of business processing operations to meet global compliance challenges head on — the importance of expert third-party partners continues to grow.

A compliance partner who has a knowledge and deep understanding of global regulations and governing bodies and a global presence in developed and emerging markets, can help guide life sciences through various obstacles. These expert partners should establish the following best practices to ensure constant compliance:

  • Baseline processes to review systems and protocols as well as documentation standards
  • Rigorous internal audits to ensure continuous improvements
  • Tracking and follow-up on leading and lagging risk indicators
  • Verification of the adequacy of the quality plan through structured co-monitoring visits and audits
  • A routine process to review and act upon evidence of deviations from the quality plan or newly emerging compliance and quality signals
  • Standardized measurement processes, such as routine monitoring, so that each customer interaction can be evaluated effectively
  • Systems to protect client’s proprietary and confidential information as well as patient privacy

 

Beyond Necessity: The Benefits of Compliance Risk Management

Third-party compliance partners bring indispensable value to life sciences companies.

At many companies, it is worth pursuing stronger compliance risk management capabilities beyond merely satisfying emerging legal requirements. As companies re-evaluate their organization’s entire approach to managing compliance risks, they are applying many of the methodologies used for financial reporting to compliance issues. They are putting formal governance and organizational structures in place, forming freestanding compliance and risk committees at the board level, and more.

Taking a risk-based approach to compliance planning, execution and monitoring makes good business sense in a heightened regulatory environment. It enables companies to focus on critical risk areas that need attention, while reducing emphasis and effort on less critical ones.

 

The Bottom Line

Both in the United States and globally, companies that fail to comply with regulatory obligations face significant repercussions — anywhere from remediation programs, audits and inspections to fines. Considering the competitiveness among companies in the industry, R&D costs and other expenditures, regulatory and compliance failures can be very damaging to companies, especially small to mid-sized ones who are building a name for themselves.

Companies who consistently demonstrate a commitment to effective regulatory compliance through transparent systems and reports build trust and show their investment in delivering improved health and overall quality of life. And those with strong track records serve as examples of best practices for the industry and regulators alike.

 


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Heather Ferrence Heather Ferrence

Director, PV Compliance

Following floor nursing in several long term care facilities and physician’s offices, Heather has over 15 years of experience in pharmaceutical, biotechnology, device and cosmetic companies. Past experience includes screening patients for clinical trials for the National Institutes of Health and numerous pharmaceutical companies, the receiving and processing of adverse events, product quality complaints and inquiries, as well as review and approval of manufacturing laboratory reports for Wyeth Pharmaceuticals products, globally. As RN, BSN, Heather’s experience bridges the worlds between healthcare at patient bed-side, pharmaceutical, device and biotechnology companies manufacturing quality assurance, regulatory reporting and requirements for C3iHC.

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