Transcript WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE WHO Technical Briefing Seminar on Essential Medicines and Health Products CAPACITY BUILDING HIS/EMP/RHT/RSS Presented by:

WHO PROGRAMME
FOR STRENGTHENING NATIONAL REGULATORY
AUTHORITIES IN THE AREA OF VACCINE
WHO Technical Briefing Seminar on Essential
Medicines and Health Products
CAPACITY BUILDING
HIS/EMP/RHT/RSS
Presented by: Dr Alireza Khadem
[email protected]
Outline
1. Background
2. WHO policy to strengthen NRAs in the area of vaccines
3. Capacity building process
4. Institutional Development Plan (IDP)
5. China success story
6. Strengthening the Regulatory Inspection Function
7. Parallel review
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8. Global Learning Opportunities (GLO)
9. Facts and Figures
10. NRA Intelligence system
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Background
WHO developed a programme to strengthen
the national regulatory capacity in the area of
vaccines and biologicals. The programme
conducted assessment to identify gaps and
used the Global Training Network (GTN) to
provide capacity building support.
Prequalification of
vaccines were linked to
NRA functionality
assessed by WHO.
WHO started the vaccine
prequalification programme
to assist countries to
procure assured quality
vaccines for their national
immunization.
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1987
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1996
2004
Bench Marking
Development of
NRA assessment
tool
1
Assessment of
NRA
Development of
Institutional
Development Plan
(IDP)
Providing
technical support,
Training/Learning,
networking,
Monitoring
progress and
impact
2
3
4
5
With or without a
road map for
prequalification of
products
WHO support
through:
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Revision of
indicators &
assessment
process
(Every 2-3
years)
Harmonizati
| tools
on4 of
Re-assessment
Every 2-5 years
Self assessment
for planning
formal
assessment

Global Learning
Opportunities
(GLO)

Technical Support

In-country training
WHO electronic
platform to monitor
NRAs information
and assessment
reports, IDP,
training, etc.
Functional NRA
WHO NRA 5 step capacity building
Capacity Building Process
• Assessment
Gap analysis
IDP
Addressing the
gaps
• A plan for addressing the
identified gaps
• Providing technical support
• Training
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Monitoring
progress and
impact
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• IDP follow-up
• Reassessment
Global Learning
Opportunities
(GLO)
In-county
workshop
Technical
Support
Institutional Development Plan
(IDP)
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6|
China: The Success Story
NRA
Assessment
IDP
2005
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NRA ReAssessment
Functional
NRA, after
assessment
in Dec 2010
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IDP
Mar/2011
Oct/2013
Q2/2014
Bench Marking
Development of
NRA assessment
tool
1
|
Assessment of
NRA
Development of
Institutional
Development Plan
(IDP)
Providing technical
support,
Training/Learning,
networking,
Monitoring
progress and
impact
2
3
4
5
+
Observed
Audit
Performance
evaluation of
GMP inspectorate
(GAP analysis)
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Basic and
Advanced
Regulatory
Inspection
Workshop +
technical
support
+
Performance
evaluation of
regulatory
inspectors
WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem
Functional NRA
Raising inspections performances:
enforcement, competencies and skills
Coached
Audit
Develop a
response to
address the gaps
of both
inspectorates and
inspectors
Regulatory Inspection
Strengthening Process
Gap analysis
IDP
Addressing the
gaps
• Assessment
• Observed audit
Global
Learning
Opportunities
(GLO)
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Coached audit
• A plan for
addressing the
identified gaps
• Providing technical
support
• Training
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Monitoring
progress and
impact
In-county
workshop
• IDP follow-up
• Reassessment
• Observed audit
 Agreed agenda (WHO and NRA)
 Pre and post workshop assessment
 Mixture of participants: regulators (NRA, NCL) and
manufacturers
 Mock inspection (planning, conducting, reporting)
 Feedback by facilitators
WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem
Developed courses
 GMP regulatory inspection using the quality risk
management approach (Basic and Advanced)
 Parallel review
 Manufacturing and control of Influenza vaccine
 Marketing Authorization Workshops for Vaccine Licensing
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 Adverse Effects Following Immunization
 NRA planning workshop to strengthen the vaccine
regulatory system
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WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem
Activities conducted: 2010 to 2013
Country
Year
Month
Cuba
India
Brazil
China
India
China
Iran
India
China
Viet Nam
India
India
Iran
China
Viet Nam
China
China
Viet Nam
China
China
China
China
China
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China
China
2013
2013
2013
2013
2013
2013
2013
2013
2012
2012
2012
2012
2012
2012
2012
2012
2011
2011
2010
2010
2010
2010
2010
2010
2009
November
September
August
June
May
Mar
Feb
Feb
Dec
Nov
Oct
Sep
Sep
Apr
Mar
Feb
Dec
Nov
Jul
Jun
May
Apr
Mar
Mar
Nov
Activity
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Basic)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Observed Audit
Observed Audit
Coached Audit
Regulatory Inspection Workshop (Basic)
Coached Audit
Coached Audit
Coached Audit
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Regulatory Inspection Workshop (Advanced-QRM)
Observed Audit
Observed Audit
NOP
24
22
24
36
27
30
24
26
27
32
32
13
6
13
24
5
5
5
24
23
24
26
24
9
10
Parallel review: steps
WHO receive a
request from a
"developing NRA"
WHO inform both NRAs
About the process and request
WHO Seek for
confidentiality agreement &
Commitment in writing
a "leading NRA"
1st training on
vaccine evaluation
Principles and
process
2nd Training
on vaccine
evaluation
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Parallel review conducted
1- 3 months
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3-6 months
12
Global Learning Opportunities
ACTIVE COURSES
 Legislation for clinical trials (ENG) FRE in process
 Clinical trails authorization (ENG) Indonesia and South Africa
 Good clinical practices inspections (ENG), Indonesia
 Evaluation of clinical data (ENG), Indonesia
 Product evaluation (ENG)
 Good manufacturing practices (ENG)
 Pharmaceutical cold chain management on wheels (ENG) Turkey, Greece
 Facilitation skills (ENG and FRE)
 Designing courses for learning (ENG)
Global Learning Opportunities
AUTHENTIC E-LEARNING
 Launched in March 2013
 Currently running ePharmaceutical cold chain
management
 e-VVM based vaccine
management to be launched in
January 2014
 Coming courses: Quality risk
management and GCP
inspections
http://epela.net
Training
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*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
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§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
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§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*National Control Laboratory
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**Expanded Programme on Immunization
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March
Training
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*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March
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NRA INTELLIGENCE SYSTEM
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Database modules
 NRA SharePoint
 NRA Planning/Monitoring System & Expert Modules
 NRA Assessment Modules
 Lot Release & Vaccine
 NRA Training | Database
 GMP Database
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Data management and monitoring:
 Benchmarking: Generic assessment tools
 Planning and conducting assessment: NRA planning, NRA
assessment report
 Identifying gaps and strengths through assessment: NRA
assessments report, IDP, GMP
 Providing technical support including training: NRA training
monitoring, IDP
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 Monitoring progress and impact and follow up: IDP, Lot
release, vaccine doses.
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Database modules
GMP
Vaccine
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Expert DB
IVB
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Related Databases
 NRA SharePoint:
https://workspace.who.int/sites/att/default.aspx
 NRA Database Management:
https://workspace.who.int/sites/nra_database/default.aspx
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Thank You