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The compliance obligations within the pharmaceutical industry continue to increase each year. Now more than ever it is critical that medical communication departments have policies and procedures that address such things as medical inquiry and response documentation, staff training, and monitoring/audit programs. Whether you have been in medical communications for a few months or a few decades, this short course will provide an overview of what policies, procedures, and programs medical communications departments should consider implementing to help ensure compliance and mitigate risk. This will be an interactive course with opportunity for discussion and questions.
At the conclusion of this short course, participants should be able to:
Discuss compliance hot topics in medical communications such as medical inquiry documentation; response development, review, and dissemination; Sunshine Act reprint reporting requirements: staff training; and sales force facilitated inquiries
Discuss FDA guidances relevant to medical communications
Describe what policies and procedures the Office of Inspector General (OIG) is requiring medical communications departments to have in place based on recent Corporate Integrity Agreements (CIA)
Identify the factors to consider when developing, implementing, and maintaining QA, compliance, and training programs
Describe how to mitigate risk in medical communications