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Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

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Page 1: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape
Page 2: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Welcome in

Pharmaceutical & Biological Regulatory

Sciences

PBRS 2015

Page 3: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

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

Page 4: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Opening Message

Whenever the art of medicine is loved, there is also a love of

humanity (Hippocrates)

Page 5: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

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.

Page 6: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Pre-Clinical Studies

Animal Trials

Page 7: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Clinical Research

Page 8: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Good Laboratory Practice

Page 9: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Good Clinical Practice

Page 10: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

New Drug Application

Page 11: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drug

Page 12: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drug-Labeling

Page 13: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drug-CMC

Page 14: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drug-Biostudies

Page 15: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drugs-Plant Inspection

Page 16: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drugs-Plant Inspection

Stab

ility

Stu

dies

Page 17: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Generic Drugs-Plant Inspection

Page 18: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Post-marketing Surveillance

Page 19: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Biologicals

Page 20: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Biologicals

Page 21: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Globalization & Harmonization

Page 22: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

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

Page 23: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape
Page 24: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape
Page 25: Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

Questions/ Comments/ [email protected]