UNIT-I:
Licensing authorities-roles and responsibilities,ICH
GCP,FDA, EU Clinical Trial Directive, Data Protection Act & Regulations
relating to electronic sgnatures,Declaration of Helsinki 2000 amendment and
financial disclosure ,Law, guidelines and codes of practiceRegulation of drug
preparation and packaging,EMEA,European directives and MRECs,Ethics committees
– history structure regulation impact of ICH GCP recent development with regard
to the INDIA/ USA / EU Clinical Trial directive
UNIT 2 :
Ethics in all
aspects of health care.Historical cases Negligence , informed consent , mental
competence Up – to – date cases: cloning, human embryos and IVF Shared
responsibilities for decisions and the understanding of risk
UNIT 3 :
Definitions
of GCP , auditing , monitoring and inspection GCP auditing requirements from a
regulatory perspective GCP compliance and audit certificates GCP auditor training
GCP audit team structure and SOPs GCP audit planning GCP audit conduct
Reporting GCP audit findings Follow – up to GCP audit reports.
UNIT 4 :
History and
purpose of GCP development of ICH GCP Roles and responsibilities in clinical research
according to ICH GCP Sponser 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, c) Professional
UNIT 5:
Regulations
in clinical research The purpose of audits Types of audits.Preparing for
audits.
In company On site The audit process Typical audit
finding What are they Resolution
How can they
be avoided
UNIT 6:
History of
regulatory affairs Main concepts QSE Sources of information Regulatory affairs
for studies in human subjects What data is needed Current and future European
requirements and procedures US perspective Recognizing why clinical research
has to meet the needs of regulatory affairs
UNIT 7:
Regulatory
submissions for new products What data is needed ? Requirements for gaining
approval US perspective Regulating control over marketing and sales of
medical products
Regulations Codes
of practice Promotional materials
UNIT 8:
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 2000Other relevant issues
TEXT BOOKS
1. Good Clinical Practices ,Central Drugs Standard
Control Organisation, Govt.
of India
2. Drugs and Cosmetics Act, 1940
REFERENCES
1. International Clinical Trial, Volume 1 &2
Dominique P.Brunier and Gerhardt
Nahler, Interpharm Press, Denver, Colorado
2. Code of Federal Regulation by USFDA - Download
3. ICH-GCP Guidelines - Download
4. Biosafety issues related to genetically modified
organism , Biotech Consortium
India Limited, New Delhi