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Overview of Global Regulatory Landscape

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Overview of Global Regulatory Landscape
Overview of Global Regulatory Landscape

Opening session 21March PBRS 2015 Overview of Global Regulatory Landscape

1. Welcome in Pharmaceutical & Biological Regulatory Sciences PBRS 2015

2. 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

3. Opening Message Whenever the art of medicine is loved, there is also a love of humanity (Hippocrates)

4. 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.

5. Pre-Clinical Studies Animal Trials

6. Clinical Research

7. Good Laboratory Practice

8. Good Clinical Practice

9. New Drug Application

10. Generic Drug

11. Generic Drug-Labeling

12. Generic Drug-CMC

13. Generic Drug-Biostudies

14. Generic Drugs-Plant Inspection

15. Generic Drugs-Plant Inspection StabilityStudies

16. Generic Drugs-Plant Inspection

17. Post-marketing Surveillance

18. Biologicals

19. Biologicals

20. Globalization & Harmonization

21. Regulatory World is not complex but very complex Regulations at a high level Need more detailed interpretation but want flexibility to evolve with science and technology changes Closing Message

22. Questions/ Comments/ Concerns oarohama@gmail.com

Source: Obaid Ali Slide Share

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