Risk based management and monitoring requires expertise, skills and the
knowledge of the industry and the regulations worldwide. No set of one company
has been ever to provide the industry with the right tools. Regulators are
always playing catch- up with the issues. Industry leaders react to issues.
Patients suffer. Because, the actual
risks are only identified if there would be a major disaster. The history of
ethical drugs and devices are full of such situations.
The use of immune oncology, Antibodies,
vaccines, and Antibody Drug Conjugates have always been a venue of immune
therapy systems.
www.gapsos.com |
The use of immune mediated adverse events, noted events which
are mitigated with treatment management algorithms which are developed by
skilled practitioner and not academicians are the challenge. The use of
mitigations of known risk factors as a method to evaluate a product is not
precise. It is rather a fractionation to an otherwise possibly preventable
risk. Drug safety groups need to be perform their vigilance based on the known
clinical venues, scientific factors, and pharmacological probabilities. Global
Allied Pharmaceuticals has been working on providing the right algorithm in
creating the proper paradigm to mitigate, analyze, and manage potential risks
via proper safety and efficacy standards.
GAP has the ability to use
multiple tools and finally use the therapeutically aligned team members to
produce the accurate, precise, and measured success. The notified bodies need
not the called in for the last time to see a reaction to a known issue. They
need to be see a proactive measure, a mitigating set of services, and a robust
Pharmacovigilance with a proper risk management techniques and appropriate
tactics. The proper individual case review, acceptable measure of rick
mitigations associated with the aggregate reporting, signal detection and
finally an overall risk benefit ration evaluation are all necessary. Management strategies for general
public, procedures, and expertise that led to the operative enactment of their
Risk Management Services are known in the industry. visit for more info http://www.gapsos.com/immuno_oncology.php
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