An Outline on importance of Harmonization to deliver safe, efficacious and quality drugs to every body of globe

1. Obaid Ali & Roohi B. Obaid
Civil Services Officer at Drugs Regulatory Authority of Pakistan

2. Harmonization Creates Opportunities for Both
Regulatory Professionals and Agencies in
Developing Countries
Roohi B. Obaid & Obaid Ali
Civil Service Officer
at Drug Regulatory Authority of Pakistan

3. Not the view of DRAP
Current judgment of speaker
No obligation on DRAP
Regulatory experience
It has nothing to do
with any specific
commercial
product
It is just a
knowledge sharing
exercise nothing
more than that
D
I
S
C
L
A
I
M
E
R

4. Can anyone
assess the Safety
Efficacy &
Quality of the
drug by naked
eye ?

5. Opening Message
Visible, Sub-visible & invisible Challenges
Harmonization, Globalization & Standardization
Projects & Map of Opportunities
Closing Message

6. If you want to go fast, go alone
If you want to go far, go together

7. About Half a billion
population died
4 Lac per year in Europe
Recall the Retard Enemies and Sad Memories

8. Recall the Retard Enemies and Sad Memories
Small pox Plague Meningitis
Tuberculo
sis
Heart
Attack
Infections Psychiatry Diabetes

9. Current Issues & Challenges
Hepatitis Ebola

10. Humans
Their systems
Their pain
S
I
M
I
L
A
R

11. Humans
Their systems
Their pain
S
I
M
I
L
A
R

12. Humans
Their systems
Their pain
S
I
M
I
L
A
R

13. Do disease has a boundary?
Quality Treatment ???

14. Every human deserves Quality Healthcare

15. Lets have a look at the back yard

16. Lets have a look at the back yard
Toxic
solvent
DEG
USA
1937
100s of
deaths
An
antibiotic
elixir

17. Lets have a look at the back yard

18. 2008
?
Lets have a look at the back yard
Over sulfated chondroitin sulfate (OSCS)

19. Lets have a look at the back yard
> 100
deaths
PIC
Tragedy
Material
Mix up

20. New
Tools
Approaches
Standards E
Q
P
S
R
E
G
U
L
A
T
O
R
Y
S
C
I
E
N
C
E

21. Safety Efficacy Quality
D R U G

22. Pre Marketing
Review
Inspection
Post Marketing
Evaluation
Challenges

23. The Regulatory World is highly complex

24. Science of Regulation
Innovation
Safety
ReasonableBalance

25. Science of Regulation
Need justifies Outcome
Benefit Risk

26. Science has one language & speaks with logic
Lets enjoy benefits of science

27. Doctor
Driver
Technician
Manufacturing
facility
Pharmacist
All require a license to work/practice

28. Harmonization saves Resources

29. Harmoniz/sation Works
ICH
Japan
EU
ICH
USA
Observers: WHO & Canada

30. Balance is required between
Fast Access
Sovereign interest
Western Medicine
Economical Interest
Innovation
Safety
Globalization
Alternative Medicine
Social Interest
Stewardship

31. International Conference on Harmonization (ICH) Philosophy
Identification and elimination of the
need to duplicate studies to meet
different regulatory requirements
More efficient use of resources in the
R&D process, as a consequence
Quicker access for patients to safe
and effective new medicines

32. Standardized
Data Elements
Controlled
Vocabularies
Common
Format
Outcomes

33. Speak same
language
Quality,
accuracy &
consistency
Improve
timeliness
CTD/eCTD
reduces
delays and
costs
Outcomes

34. Global Regulatory Initiatives
Joint Inspections
Joint investigations
Mutual Recognition
Data sharing
Memorandum of
Understanding

35. APEC ASEAN GCC PANDRH SADC
A Bridge from ICH to the world beyond
Openness and Transparency
Regional Harmonization Initiatives

36. International
Compatibility
Way to move forward
Globalization
Regulatory burden
Innovation and Risk
Capacity and
Capability
T
I
M
E

37. Error

40. Models of Projects (Example)
Brand Name Analysis

41. Sound and look alike……
Amaryl
Reminyl
Amaryl
Reminyl
Celebrex
Cerebyx
Celebrex
Cerebyx
Omacor
Amicar
Omacor
Amicar

43. Intelence (Etravirine) Tablets
Letters in Name
INTELENCE
Scripted may appear
as
Spoken may be interpreted as
I e. L any vowel
n v, r, s, m
t f, r, x d
e i, l any vowel
l b, e, h
c a, r S
Look a like and sound alike letters

44. Relative Scale of Concerns
N
G
B
S E Q
S E Q
QES

45. Pre-Market Compliance Post-Market
G
B
N
Safety
Efficacy
Quality

46. Equal voice
Consistency & Uniformity in decision
Question based Review & Critical Thinking
Organizational Approach

47. Learn, De-learn & Re-learn

48. Thanks