Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
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Pharmaceutical Medicine
Personnel - The Knowledge Gap
Science Policies
International
Regulations Regulations
local / local
international
Industry Academia
Company Institute
policy local / Regulations
international
Clinical Trial : Conduct and Plan
Good
Fast
Cheap
All biomedical
Clinical trials for
research at all
Scope : regulatory
stages of drug
submission
development
Structure
• Essentiality
• Voluntariness, Informed consent and
community agreement
• Non-exploitation
• Privacy and confidentiality
• Precaution & risk minimisation
• Professional competence
Ethical Principles of Indian GCP
• Details of composition
• Quorum - minimum of 5 members
• Decision making process
• Can order discontinuation of trial if the
goals are achieved or unequivocal results
obtained
• Records to be retained for at least 5 years
after completion / termination of study
Informed Consent
• Ensure freedom of consent for vulnerable
groups and members of group with a
hierarchical structure
• Right to prevent use of biological samples
• Free treatment of research-related injury
• Possible current and future use of
biological material
• Risk of discovery of biologically sensitive
information
• Publication plan
Compensation
• Definition of Phases I – IV
• Concurrent Phase II-III
• Central lab and trial samples
• Flexibility in data requirements for new
drugs for life threatening / serious
conditions or disease of relevance to India
• Classification of Fixed Dose Combinations
for clinical studies
Phase IV Studies
• Children
• Pregnant or nursing women
• Socio-economically disadvantaged
• Mentally challenged
• Students, Subordinates, Employees
• Army personnel
• Prisoners
Clinical Trials in Children
• Content of Protocol
• Structure and content of report
• Undertaking by investigator
• Checklist of contents for ICF
• Format of EC approval, ICF
Special Research Areas
• Vaccines
• Contraceptives
• Herbal
• Surgical procedures / Medical devices
• Diagnostic agents – radioactive material
• Genetics
• Epidemiology
• National priorities
• Biotechnology
Herbal Research
Confucius