Creating a Compliant Culture

Creating a compliant culture: In this age of distributed data sources, commercialization of IT with “bring your own devices,” the demands of business to get faster and unrestricted access to data, compliance teams are more challenged than ever before. The reality is that although the onus of compliance and regulatory reporting fall to the select few within the enterprise that bear that title, being knowledgeable about best practices in handling sensitive data, and doing business in a compliant way is everyone’s responsibility.
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FDA Warning Letters: Alerting Signs are Always There

Keep an eye for the warning signs in your internal procedures and processes to reduce the risk of being caught by the FDA.
Oops! I got the FDA warning letter. Now what should I do?  How should I respond to prevent further enforcement actions by the Agency?  And all the other barrage of questions scares you. Look at it differently.  How do you foresee that a warning letter is coming? What are the signs that can help you anticipate a letter from the Agency? If you can do that, then hopefully, you can take steps to avoid one and resolve it before FDA knocks your door.

Warning Letter Trends

In the recent past the FDA has made an effort to speed up the warning letter program. This means that they will no longer build an airtight legal case before issuing the letter. Multiple warning letters are also no longer being issued. In some cases, the FDA has shown that it will not even issue a formal letter before shutting down a facility, recalling products or revoking licenses.
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Does Your Incentive Compensation Plan Need a New Prescription?

In today’s regulatory environment, the pharmaceutical sales incentive plan is one area that receives deserved close scrutiny by compliance departments. The reason? A company’s incentive plan can be used as evidence of encouraging non-compliant behavior, especially around off-label promotion. Due to the risks this creates, it is crucial that companies demonstrably encourage a culture of compliance, implementing compliance-cautious strategies for compensating their sales force.
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China’s Regulatory Review on New Drugs and Oncology Market

China poses new and unique compliance challenges for pharmaceutical companies that are aiming to work in the country. The Chinese government has been proactive in approving new, safe pharmaceuticals quickly, as well as in protecting its population. There is a dire need for oncology pharmaceuticals, especially for lung cancer, as it is the most prevalent type in China, according to China’s 2015 cancer statistics report. There are many factors concerning China’s regulatory review on new drugs and the oncology market to understand when entering this market.
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Paradigm Shift – Project-based Engagement to SLA/Capacity-based Compliance Outsourcing

Life science companies are still struggling to find the right balance in managing IT compliance, quality and cost. They must meet compliance requirements for multiple regulations, while at the same time are under significant pressure to cut costs, reduce permanent staff, and outsource activities that are not part of their core business. Compliance costs are considered a significant overhead, especially when not done effectively. To optimize these costs while increasing work quality, firms are moving away from project-based engagements to service level agreement (SLA)/capacity-based models.
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Three Questions to Ask Your CMO about Standard Operating Procedures

Developing and implementing standard operating procedures (SOPs) are an important part of drug development and manufacturing. Done correctly, SOPs provide consistency and ensure that procedures meet FDA standards. Done poorly, they can be unclear, leading to errors and inconsistencies and focus on the how but not the why.  A challenge of enforcing quality SOPs is that information can become quickly outdated because of constantly updated FDA regulations.
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