The document discusses ensuring safety and quality in the pharmaceutical industry. It notes that hundreds of deaths still occur each year due to issues like contamination, cross-contamination, and consistency problems in drug manufacturing. It emphasizes that both pharmaceutical companies and regulatory agencies must work to establish reasonable safety regulations and oversight throughout the entire drug development and manufacturing process, from concept and testing to post-registration quality surveillance and pharmacovigilance. The talk also highlights the important roles of pharmacists and continual learning to maintain a proper balance between innovation and patient safety.

1. Pharmaceutical Sciences at
Progressive Mode
10 Oct 2017,
Faculty of Pharmacy, Hamdard University & University of Karachi
Obaid Ali, R. Ph., M.Phil., Ph. D.
Civil Service Officer/ DRAP, Government of Pakistan
Member ISPE & PDA

2. Disclaimer: Not the obligation of organization or association from where I
belong, will be discussing science behind, current scenarios, strategies,
approaches and tools to minimize the potential of harm

3. Priority

4. About 0.5 billion died
0.4 million/year-Europe

5. Small pox Plague Meningitis
Tuberculos
is
Heart
Attack
Infections Psychiatry Diabetes

6. Hepatitis Ebola

7. Who Cares?
It is Pharmaceutical Industry … Science … Research ..

8. Pharmaceutical
Companies
Regulatory
Agencies

10. Safety Efficacy Quality
D R U G

11. Pre-Registration Post-RegistrationManufacturing

12. Pre-Registration Post-RegistrationManufacturing
Concept and Animal Studies

13. Pre-Registration Post-RegistrationManufacturing
Concept and Animal Studies
Clinical Studies

14. Regulations Protect
&
Promote Public Health

15. Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up

16. Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up
Within Batch
Batch after Batch

17. Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up
Within Batch
Batch after Batch
With same product of other batch, or other
product or dust, or microbe

18. 125% 75%
98%
102%

21. 150 lives
Pakistan
149 deaths
USA
Meningitis
Outbreak
It is 21st Century

22. 100’s
of
Deaths

24. Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance

25. Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance
Quality Surveillance

26. Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance
Quality Surveillance
Medication Safety

27. The lives of 22,000
patients in USA alone
could have been saved
if U.S. regulators had
been quicker to ban it.

28. Pre-Registration Post-RegistrationManufacturing

29. Pre-Registration Post-RegistrationManufacturing
New Drug Generic Drug

31. Pre-Registration Post-RegistrationManufacturing
Pharmacists

32. Pre-Registration Post-RegistrationManufacturing
Pharmacists
Health Care Sciences, Pharmaceutical Science,
Pharmaceutical Engineering

37. Innovation Safety
Reasonable Balance

38. Vision
Quantifiable Not quantifiable
2+2=4 Infinite

39. Cultural
Emotional
Intellectual
Perceptual
Block

40. Where does your knowledge stand?
Keep an eye on yourself

41. Learn, De-learn & Re-learn
Thanks