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Ethical Issues In Vaccine Clinical Trials | 7525
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

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Ethical issues in vaccine clinical trials

2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

B.D. Darade and A.S. Khairnar

Accepted Abstracts: Pharmaceut Reg Affairs

DOI: 10.4172/2167-7689.S1.008

Abstract
Participation of children in vaccine trials is a complex, legal, and ethical issue. Greater efforts should be made to develop vaccines in developing countries. Such trials involve not only significant scientific challenges but also complex economic & ethical considerations, Paediatric age groups are significantly vulnerable as a research subject, in a vaccine trials conducted in developing countries. Such trial should be justified with the participated populations. There should be equitable sharing of benefits and risks. Ethically and scientifically explanation about the use of population. End point priority after vaccine trial is to improve child survival and prevention of diseases & to overcome the morbidity and mortality. The inform consent form should explain the purpose, risk & benefits, comparator & care. It should be voluntarily and inform. This topic explains vulnerability of child, benefits and risk, adolescent participation, inform consent/confidentiality, compensation, and regulatory framework.
Biography
I did my medical graduation in B.H.M.S. Myself is doing PG.in Pharmaceutical Medicine From "University Department of Interpathy Research and Technology (UDIRT)",Maharashtra University of Health Sciences (MUHS), Nashik.
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