(BT05502) REGULATORY AFFAIRS AND CLINICAL TRIALS

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 2003

Other 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