Develop a list of topical areas of risk

Develop a list of topical areas of risk

Assignment 1:

Develop a list of topical areas of risk that should be included in a Compliance Risk Assessment for a pharmaceutical company. Note the categories of information that you would obtain for each and which would be quantitative and qualitative.

You did a similar exercise for a financial services company in Assignment.
Based on tonight’s lecture, identify a minimum of four risk areas for a pharmaceutical company and then drill down on the categories of information you would need to obtain under each.

Assignment 2:

Develop a background checklist for an entry level employee at your pharmaceutical company and then draft a table of contents for an employee handbook based on the employment law topics discussed in class.

NEW: Also, review the GSK story in the New York Times and then research GSK’s 2012 $3 Billion settlement relating to Paxil, Wellbutrin and Avandia

Background Checklist should be 2-3 pages and include the information you would like to know about a potential employee that is also legally permissible.
Table of Contents for the Employee Handbook should cover the appropriate areas of Employment Law discussed in the employee law risk lecture.

GSK Settlements: Come to class prepared to present the issues raised in both the 2012 and 2016 Settlements focusing your presentation on indentifying the compliance risks in each of the settlements and the Compliance Program elements that could have prevented them. Also, you should be prepared to discuss how a Compliance Risk Assessment would or could have pre-identified these risks.
In class on November 9, I will select a group of three to discuss the 2012 settlement and another group of three to discuss the 2016 settlement. Selection will be random. Those not selected to present will be expected to contribute and participate in the discussion.

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