Accelerating Information Governance Within Pharma

The lack of proper information management continues to be rampant across heavily regulated industries, with pharma and healthcare seeing their fair share of challenges. This is especially alarming as companies in these sectors generate massive amounts of sensitive data and intellectual property on a daily basis. For some, information is stored in numerous repositories across multiple jurisdictions. From clinical reports and research data to financial and corporate information, there is a growing need to ensure the reliability, security and accuracy of this information. In addition, the latest news of network breaches, security leaks and data hacks and losses have forced executives to make sure there is accountability for such instances.
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In The Headlines


The Role of Regulatory Affairs in Drug Compliance

Pharmaceutical companies face significant challenges in developing new, innovative medicines:

• Pharma R&D investment has increased 62 percent in the last decade, but the number of new drugs approved is 22 percent lower than the previous decade.
• The failure rate in phase III, the most expensive part of pharma R&D, is 40 percent.
• A Datamonitor study of 346 NDAs found that 42 percent of submissions received a complete response letter, resulting in a median delay in approval of 13 months.
• Cost cutting and the retirement of baby boomers with deep expertise have resulted in a shortage of in-house experts with the savvy to drive innovation and gain regulatory approvals.
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Topic of Discussion


Taking the Pulse on New Regulations Impacting Health Care Auditing

The busiest time of year for auditing health care financial statements is upon us, and this year, there are have been several widespread changes in the health care industry that will impact how these audits are conducted:
  • Industry consolidation and the related business combination accounting rules;
  • Increased activity of risk-based payment arrangements; and
  • Taxes and net premiums written for health insurance.

These audit issues can be complex so external third party auditors and their clients should work together on these issues during the planning phase of the audit to avoid any delays and be able to satisfy the looming deadlines.
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