The Relevance Of Safe Final Destination And Rational Prescription Of Drugs Under Regulatory Issues With Inclusion Of Environmental Impact Analysis On Pharmacoeconomics Studies | 13817
Pharmaceutical Regulatory Affairs: Open Access
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The final destination of medicine residues is a relevant subject to the public health due to the pharmacological properties of
each medicine and inputs, that in future will become a residue and will need to be treated. We don?t have specific guidelines
for medicines classification and pharmaceutical waste. A range of methodologies are available for pharmacoeconomics evaluation
but they didn?t incorporate adverse environmental effects causing physiological disturbances for humans and animals. The
industrial segment follows different regulations that are formulated for industry in general. Thus the way done by drugs and
inputs generated from manufacturing to the use by the end user fragments in the legislation because the process of classification
to the final destination are not clearly defined. The goal of this monograph is propose to the Official Regulatory Agency create
guidelines for the development of a classification system specifically for pharmaceutical waste to support the choice for drugs
with pose little risk to environment and health in cases where several comparable therapeutically-equivalent, safety and costs are
available. The inclusion of environmental impact data about pharmaceuticals in such selection process maybe a tool to stimulate
drug manufactures to design pharmaceutical products that are less persistent after excretion, ?green? technology to production,
standardization and acquisition of these kind of drugs and other proactive actions in order to minimizing the introduction of
pharmaceutical residues to the environment.
Nubia Regina de Oliveira, Pharmacist, has completed her post-graduation at Regulatory Affairs and Sanitary Surveillance from Federal University
of Rio de Janeiro in 2011 and post-graduation at Industrial Pharmacy from Estacio de Sa University in 2008. She is Quality and Regulatory
Affairs Manager of Mega Surgical importer of Medical Devices for Spinal and Orthopedic Surgeries. She has expertise upon international planning,
training and following up international inspection for GMP certification, government approvals for medical devices and other health products, quality
management and human resources training for quality guarantee system issues.
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