Drug development regulation is the process by which new drugs are tested, evaluated, and approved for use by regulatory authorities such as the US Food and Drug Administration (FDA). The regulation of drug development is based on principles of safety, efficacy, and quality.
Good Clinical Practice (GCP) is a set of principles that govern the conduct of clinical trials. These principles include the protection of human subjects, adherence to a study protocol, the collection of reliable and accurate data, and the maintenance of records and reports. The FDA and other regulatory authorities require that all clinical trials be conducted in accordance with GCP guidelines to ensure that the data generated is reliable and accurate.
The principles of GCP are based on international ethical and scientific quality standards and are designed to ensure the safety and well-being of study subjects, as well as the scientific integrity of clinical trials. Adherence to GCP is essential to ensure that clinical trial results are credible, accurate, and can be used to support the approval of new drugs by regulatory authorities.
An Investigational New Drug (IND) application is a request submitted to the US Food and Drug Administration (FDA) for permission to conduct human clinical trials on a new drug or biologic. The application must include detailed information about the drug’s composition, manufacturing, pharmacology, toxicology, and clinical trial protocol. The FDA reviews the IND application to ensure that the proposed clinical trials are safe and scientifically valid. If the application is approved, the sponsor of the drug can proceed with the clinical trials. The IND process is an important step in the drug development process and helps ensure that drugs are safe and effective before they are marketed to the public.
This course examines the international regulatory framework of drug development regulation focusing on details of the licensing process and timelines of drug approvals in the USA.
Bioethics, History, and Current Standards
Principles of GCP
International Standards of Drug Regulations and Development
ICH overview and Guidelines
US Drug Legislation / FDA structure and responsibilities
IND Application process and documentation
US Privacy Legislation
US Privacy Legislation (HIPAA)
Basics of Common Technical Documents (CTD)
Introduction to Audits or Inspections
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