Discuss recent off-label cases.
Appraise the current business risk environment.
Discuss what needs to be done to prepare the organization for a CIA.
Describe how to strengthen MSL interaction with physicians.
Examine Medical Affairs personnel interactions with P&T commimttees and others in managed care.
Discuss FDA Compliance Actions on advertising and promotion.
Discuss lessons learned from the latest off-label indictments and settlements.
Discuss criteria used in recent enforcement actions.
List safeguards to help minimize violations.
Explore areas that should still be considered high risk for enforcement activity, despite the new guidelines for reprint dissemination that FDA proposes.
Identify methods to ensure knowledge of policies and company compliance regulations.
Identify frequency of documentation.
Define the external provider's role and responsibility in auditing.
Do you believe this activity was appropriate for the scope of your professional activities?
List any perceived practice "gaps" (educational needs/topics) which you would like to see the focus of future trainings.
Are you interested in basic, intermediate or advanced level trainings?
What barriers might you have that would interfere with implementation of new information learned from this training?
How can this training be improved to impact your competence or practice?
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