PHR 3503 - Pharmaceutical Regulatory Compliance

3 Credit Hours

Based on a solid foundation in regulatory theory and practice, the purpose of this course is to study the authority and responsibilities of three federal agencies that are entrusted to ensure the safe, effective, and efficient use of medications in the United States. The practices and procedures of the Food and Drug Administration, Drug Enforcement Administration, and Centers for Medicare and Medicaid Services are reviewed. The importance of pharmacists and other health care professionals in assuring compliance with regulatory principles will be emphasized. Students will acquire the knowledge and skills necessary to function at an entry level in the field of pharmaceutical regulatory compliance.

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