The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.

1. Microbiology &
Pharmaceutical Transformation
DRAP Lead for
Scientific Transformation Initiatives
Alumni CDER-USFDA, HPFB-Health Canada
Honorary Adviser
OR - Centre for Quality Science
Federal Urdu University of Arts, Science & Technology
Karachi the 15 December 2021
Obaid Ali, RPh., PhD.

2. Thank you all
Dr. Sadia Khalil & colleagues
Disclaimer
Personal Point of view
based on knowledge and
experience gained in the
last three decades

3. Clinical
Trial
New
Drug
Generic
Drug
Mfg
Vigilance
Research
Microbiology

4. Concept Evidences
Experiment
Verification
Hypothesis Working Design

5. Human
Safety
Efficacy
Verification
Oversight

6. Quality
Claim
Promise

7. Similar CMC Plant Claim

8. Consistency
Mix up
Contamination

9. Surveillance Signals
Variations Vigilance

10. Microbiology &
Pharmaceutical Transformation
DRAP Lead for
Scientific Transformation Initiatives
Alumni CDER-USFDA, HPFB-Health Canada
Honorary Adviser
OR - Centre for Quality Science
Federal Urdu University of Arts, Science & Technology
Karachi the 15 December 2021
Obaid Ali, RPh., PhD.

11. WWW.ORCQS.COM
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