Bioethics and Regulatory Compliance

Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in medicine. It is also moral discernment as it relates to medical policy, practice, and research. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, clinical research, and philosophy etc. One of the first areas addressed by modern bioethicists was that of human experimentation. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was initially established in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.

Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Quality of clinical trials depends on data integrity and subject protection. Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process.

 

  • Compliance and regulatory requirements in clinical research
  • Bioethics: Case studies and ethical regulatory guidelines
  • Ethics and patient’s rights
  • Ethics & Human subject protection
  • Value of ethics in clinical research
  • Regulatory implications and opportunities with new technologies
  • New regulatory flexibility driving positive industry change
  • Navigating the clinical trials regulatory landscape
  • Bridging regulations to Real-World health care
  • Good clinical practice
  • Ethical challenges in cancer clinical trials

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