Bioethics Biotech 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective IV) detail syllabus for Biotechnology (Biotech), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (BT8012), Category (PE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other biotech 6th sem syllabus for b.tech 2017 regulation anna univ you can visit Biotech 6th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects. For all other Professional Elective IV subjects do refer to Professional Elective IV. The detail syllabus for bioethics is as follows.
Course Objective:
- The course will provide Fundamental ethical to Advanced clinical trial management including drug development and trial planning; Project management in clinical trials; Consent and data protection; Quality assurance and governance.
Unit I
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Unit II
Regulations of Clinical Trials
Drug development and trial planning – pre-study requirements for clinical trials; Regulatory approvals for clinical trials; Consort statement; Trial responsibilities and protocols – roles and responsibilities of investigators, sponsors and others; Requirements of clinical trials protocols; Legislative requirements for investigational medicinal products.
Unit III
Management and Ethics of Clinical Trials
Project management in clinical trials – principles of project management; Application in clinical trial management; Risk assessment; Research ethics and Bioethics – Principles of research ethics; Ethicalissues in clinical trials; Use of humans in Scientific Experiments; Ethical committee system including ahistorical overview; the informed consent; Introduction to ethical codes and conduct; Introduction to animal ethics; Animal rights and use of animals in the advancement of medical technology; Introduction to laws and regulation regarding useof animals in research.
Unit IV
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Unit V
Quality Control and Guidelines
Quality assurance and governance – quality control in clinical trials; Monitoring and audit; Inspections; Pharmacovigilance; Research governance; Trial closure and pitfalls-trial closure; Reporting and legal requirements; Common pitfalls in clinical trial management.
Course Outcome:
- The students will acquire knowledge in all aspect of clinical trials, management and ethical standards required to conduct clinical trials.
References:
- Lee, Chi-Jen; etal., Clinical Trials or Drugs and Biopharmaceuticals. CRC / Taylor &Francis,2011.
- Matoren, Gary M. The Clinical Research Process in the Pharmaceutical Industry.Marcel Dekker,1984.
For detail syllabus of all other subjects of B.Tech Biotech, 2017 regulation do visit Biotech 6th Sem syllabus for 2017 Regulation.
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