This course will focus on the laws and regulations, documentations and process imposed by the Federal government especially the Food and Drug Administration related to pharmaceutical and medical device approval. The course will provide students with detailed knowledge and practical application as it applies to appropriate documentation and process of approval for pharmaceutical and medical devices. The students will understand the nomenclature of the regulatory agencies; have a thorough knowledge of the code of Federal Regulations as it applies to medical devices and pharmaceutical products.
- Understand the Code of Federal Regulations as it applies to medical device and pharmaceutical product approval.
- Completion of an Investigative New Drug or Investigative Device Exemption Form.
- Complete a risk analysis grid for a drug or device.
- Understand and submit appropriate documentation for Institutional Review Board approval.
- Procedure and documentation for submission for approval of a new drug or device.
- Understand the international harmonization process.
- Understand and be able to document adverse events and recall of products.
- Develop and implement Clinical Report Forms.
- Have a thorough understanding of the various regulatory agencies of the Food and Drug Administration.
- Prepare for a meeting with the Food and Drug Administration.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 180,000 alumni worldwide.
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