Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape
Apr 21, 2017
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Transcript
Welcome in
Pharmaceutical & Biological Regulatory
Sciences
PBRS 2015
Overview of Global Regulatory Landscape
Roohi B. Obaid, R. Ph., M. Phil &
Obaid Ali, B. Sc, B. Pharm., M. Phil., Ph. D
A simple outline of
PBRS 2015
Opening Message
Whenever the art of medicine is loved, there is also a love of
humanity (Hippocrates)
Behind the Regulatory Science
When a patient seeks for treatment of a disease he may experience
an unwanted sometimes horrible potential of risk associated with drugs
or devices or errors etc.
Pre-Clinical Studies
Animal Trials
Clinical Research
Good Laboratory Practice
Good Clinical Practice
New Drug Application
Generic Drug
Generic Drug-Labeling
Generic Drug-CMC
Generic Drug-Biostudies
Generic Drugs-Plant Inspection
Generic Drugs-Plant Inspection
Stab
ility
Stu
dies
Generic Drugs-Plant Inspection
Post-marketing Surveillance
Biologicals
Biologicals
Globalization & Harmonization
Regulatory World is not complex but very complexRegulations at a high level
Need more detailed interpretation but want flexibility to evolve with science and technology changes
Closing Message
Questions/ Comments/ [email protected]
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