JNTUK B.Tech Bioethics, Bio Safety, Clinical Regulatory Affairs gives you detail information of Bioethics, Bio Safety, Clinical Regulatory Affairs R13 syllabus It will be help full to understand you complete curriculum of the year.
UNIT I: INTRODUCTION TO BIOETHICS
Introduction to Bioethics. Social and ethical issues in Biotechnology. The principles of Bioethics, autonomy, human rights, privacy justice, ethics related to use of experimental animals. ICMR guide lines.
LO: To familiarize about bioethics and its principles.
LA: Assessment by the ability to apply these bioethical laws.
UNIT II: BIOSAFETY
Definition of Biosafety. Biosafety for human health and environment. Social and ethical issues. Use of genetically modified organisms and their release in to the environment. Special procedures for r-DNA based products.
LO: To make a detailed study of biosafety and other ethical issues.
LA: Assessment by implementation of biosafety issues.
UNIT III: LICENSING GUIDELINES.
Licensing authorities-roles and responsibilities, Data Protection Act & Regulations, Declaration of Helsinki 2000 amendment and financial disclosure; Regulation of drug preparation and packaging, structure regulation impact of ICH GCP recent development with regard to the INDIA;/USA/EU Clinical Trial directive.
LO: To understand the licensing and regulating authorities of drug preparations.
LA: Assessment by monitoring and implementing the regulatory issued during drug preparation.
UNIT IV: QUALITY ASSURANCE GUIDELINES
Definitions of GCP, auditing, monitoring and inspection; GCP auditing requirements from a regulatory perspective; GCP compliance and audit certificates; GCP audit team structure and SOPs’ GCP audit planning; GCP audit conduct; Reporting GCP audit findings; Follow up to GCP audit reports. GLP guidelines.
LO: To demonstrate good clinical practices and other governing factors.
LA: Assessment by proper application of GCP guidelines during the process development.
UNIT V: GUIDELINES FOR CLINICAL TRIALS
Roles and responsibilities in clinical research according to ICH GCP Sponsor, Monitor, Investigator, IRB/IEC; Essential documentation; The INDIAN/USA/EU Directives on GCP in Clinical Trials. Purpose; How will the introduction affect clinical research; Extracts from the guidance documents. Possible sanctions for non-compliance (a) Legal and regulatory (b) Commercial and (c) Professional.
LO: To demonstrate international regulatory guidelines.
LA: Assessment by implementation of these guidelines.
UNIT VI: ICH GUIDELINES
Latest developments in ICH; Purpose; Implications; Guidance notes; Inspections. INDIAN/USA/EU Ethics approval system: Overview; Recent developments. Current issues in Clinical research: Confidentiality issues; Medicines for human use (clinical trials) regulations 2003; other relevant issues.
LO: To familiarize about national and international clinical trials guidelines.
LA: Assessment by implementing and checking the guidelines.
TEXT BOOKS
- Sasson A, Biotechnologies and Development, 3rd edition, UNESCO Publications, 2000.
- Sasson A, Biotechnologies in developing countries present and future, 2nd edition, UNESCO publishers, 2000.
- Good Clinical Practices, Central Drugs Standard Control Organization, Govt. of India
REFERENCE
- Lawrence M. Friendman, Curt D. Furberg, David L. Demets, Fundamentals of clinical trials, 3rd Edition, Springer International Edition, 2010.
- Drugs and Cosmetics Act, 1940.
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