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Risk Based Approach to Compliance Monitoring
Price: From $298.00 to $1,200.00
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Many corporate compliance programs have historically focused on policies and training. Increasingly, companies--and the government--are starting to focus on monitoring, to make sure that the policies and training are effective, and to determine potential areas of improvement. Monitoring can, however, be a daunting task: there are numerous risk areas, with a myriad of employees and contractors in far-flung locations who, on a daily basis, may or may not be engaging in high risk activities. In addition, monitoring can be very expensive and labor intensive.
To meet these challenges, companies should adopt prioritized, focused, practical, robust and reliable compliance monitoring plans to help ensure that employees and contractors are doing the right thing, that the company knows whether it's in compliance, and that it can demonstrate that it engaged in good faith efforts to ensure compliance.
Key Topics Include:
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The Seven Elements of a Comprehensive Compliance Program
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Methods for risk assessment/prioritization
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Deciding when to monitor, and whether to monitor or audit
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Selection of issues to monitor - based on internal risk assessment
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Practical considerations - frequency, sample size and staggering of monitoring events
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Documentation of monitoring
Who Should Purchase:
You will benefit from purchasing this webseminar if you are a senior-level professional at a pharmaceutical, biotech or medical device company with responsibilities or involvement in the following areas:
About Our Presenter:
Mark D. Lurie, Principal, Law Office of Mark D. Lurie LLC
Mark Lurie is the principal of the Law Office of Mark D. Lurie LLC, which focuses on compliance advice and services for the pharmaceutical and medical device industries. The firm also focuses on employment law and litigation, with a particular emphasis on whistleblower allegations and internal investigations.
Before forming his own legal practice, Mark was the Vice President and Chief Ethics and Compliance Officer at Eisai Corporation of North America, a mid size pharmaceutical company. Mark was responsible for the creation, oversight and evolution of the company's compliance function for more than six years, and chaired Eisai's US compliance committees. In that role, Mark created risk assessment tools and prioritized risks, and created policies and procedures (including codes of conduct, policies on interactions with healthcare providers, Foreign Corrupt Practices Acts policies and procedures, Fair Market Value policies and procedures, a ground breaking system to track payments to healthcare providers, and other policies and procedures). Mark provided substantial and ongoing training to all employees, both live and electronically. Mark also participated in due diligence activities, conducted and oversaw investigations, and prioritized audits and monitoring activities. Prior to heading its compliance efforts, Mark was Eisai's senior employment counsel, responsible for day-to-day employment advice, oversight and resolution of employment disputes, conducting internal investigations, providing training, and creation of employment-related policies, as well as oversight of all litigations.
Mark was a partner in the Labor and Employment Group of Epstein Becker & Green before joinging Eisai. Mark successfully litigated numerous whistleblower, discrimination, harassment, retaliation, breach of contract and other employment-related disputes. Mark was also an employment litigator at Proskauer Rose and McCarter & English. Mark has practices in state and federal courts, at both the trial and appellate levels, as well as in administrative and arbitration proceedings.
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