WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE
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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]
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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. Background - PowerPoint PPT Presentation
Transcript of WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE
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/RSSPresented by: Dr Alireza Khadem
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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
8. Global Learning Opportunities (GLO)
9. Facts and Figures
10. NRA Intelligence system
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Background
WHO started the vaccine prequalification programme to assist countries to procure assured quality vaccines for their national immunization.
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.
1987 1996 2004
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WHO NRA 5 step capacity building
Bench Marking
Development of NRA
assessment tool
Assessment of NRA
Development of Institutional
Development Plan (IDP)
Providing technical support,
Training/Learning,
networking,
Monitoring progress and
impact
Func
tiona
l NR
A
1 2 3 4 5
Re-assessment
Every 2-5 years
Self assessment for planning
formal assessment
Revision of indicators
& assessment process (Every 2-3
years)
Harmonization of tools
With or without a road map for
prequalification of products
WHO support through:
Global Learning Opportunities (GLO)
Technical Support In-country training
WHO electronic platform to monitor NRAs information and assessment
reports, IDP, training, etc.
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Gap analysis
• Assessment
IDP
• A plan for addressing the identified gaps
Addressing the gaps
• Providing technical support• Training
Monitoring progress
and impact
• IDP follow-up• Reassessment
Capacity Building Process
Global Learning
Opportunities (GLO)
In-county workshop
Technical Support
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Institutional Development Plan(IDP)
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China: The Success Story
2005 Mar/2011 Oct/2013 Q2/2014
NRA Assessment
Functional NRA, after assessment in Dec 2010
NRA Re-Assessment
IDPIDP
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8 | WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem
Bench Marking
Development of NRA
assessment tool
Assessment of NRA
Development of
Institutional
Development Plan
(IDP)
Providing technical support,
Training/Learning,
networking,
Monitoring
progress and
impact
Func
tiona
l NR
A
1 2 3 4 5
Coached
Audit
Basic and Advanced Regulator
y Inspectio
n Workshop
+ technical support
+ Observ
ed Audit
Performance evaluation of
regulatory inspectors
Performance evaluation of
GMP inspectorate
(GAP analysis)
+Develop a
response to address the gaps
of both inspectorates and
inspectors
Raising inspections performances:enforcement, competencies and skills
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9 | WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem
Regulatory InspectionStrengthening Process
Global Learning
Opportunities (GLO)
In-county workshop
Coached 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
Gap analysis
• Assessment• Observed audit
IDP
• A plan for addressing the identified gaps
Addressing the gaps
• Providing technical support
• Training
Monitoring progress
and impact
• IDP follow-up• Reassessment• Observed audit
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10 | 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
Adverse Effects Following Immunization
NRA planning workshop to strengthen the vaccine regulatory system
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Activities conducted: 2010 to 2013Country Year Month Activity NOP
Cuba 2013 November Regulatory Inspection Workshop (Advanced-QRM) 24India 2013 September Regulatory Inspection Workshop (Basic) 22Brazil 2013 August Regulatory Inspection Workshop (Advanced-QRM) 24China 2013 June Regulatory Inspection Workshop (Advanced-QRM) 36India 2013 May Regulatory Inspection Workshop (Advanced-QRM) 27China 2013 Mar Regulatory Inspection Workshop (Advanced-QRM) 30Iran 2013 Feb Regulatory Inspection Workshop (Advanced-QRM) 24India 2013 Feb Regulatory Inspection Workshop (Advanced-QRM) 26China 2012 Dec Regulatory Inspection Workshop (Advanced-QRM) 27
Viet Nam 2012 Nov Regulatory Inspection Workshop (Advanced-QRM) 32India 2012 Oct Regulatory Inspection Workshop (Advanced-QRM) 32India 2012 Sep Observed Audit 13Iran 2012 Sep Observed Audit 6
China 2012 Apr Coached Audit 13Viet Nam 2012 Mar Regulatory Inspection Workshop (Basic) 24
China 2012 Feb Coached Audit 5China 2011 Dec Coached Audit 5
Viet Nam 2011 Nov Coached Audit 5China 2010 Jul Regulatory Inspection Workshop (Advanced-QRM) 24China 2010 Jun Regulatory Inspection Workshop (Advanced-QRM) 23China 2010 May Regulatory Inspection Workshop (Advanced-QRM) 24China 2010 Apr Regulatory Inspection Workshop (Advanced-QRM) 26China 2010 Mar Regulatory Inspection Workshop (Advanced-QRM) 24China 2010 Mar Observed Audit 9China 2009 Nov Observed Audit 10
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Parallel review: stepsWHO receive a request from a "developing NRA"
WHO Seek for a "leading NRA"
WHO inform both NRAsAbout the process and request
confidentiality agreement &
Commitment in writing2nd Training on vaccine evaluation
1 -3 months
1st training on vaccine evaluation Principles and process
3-6 months
Parallel review conducted
Global Learning Opportunities
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)
ACTIVE COURSES
Global Learning Opportunities
AUTHENTIC E-LEARNING
http://epela.net
Launched in March 2013 Currently running e-
Pharmaceutical cold chain management
e-VVM based vaccine management to be launched in January 2014
Coming courses: Quality risk management and GCP inspections
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Training
*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory
**Expanded Programme on Immunization
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013
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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 toolsPlanning and conducting assessment: NRA planning, NRA
assessment report Identifying gaps and strengths through assessment: NRA
assessments report, IDP, GMPProviding technical support including training: NRA training
monitoring, IDPMonitoring progress and impact and follow up: IDP, Lot
release, vaccine doses.
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Database modules
Expert DB
IVB
NRA Assessmen
t
NRA Team
IDP
Generic tools
NRA Planni
ng
Work plan
Activity
CV
NRA Training
Trainees
Training
Centers
Lot Relea
se
Certificate
Vaccine
GMP
NRA country Profile
Vaccine
Training
Activities
Assessment
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NRA SharePoint: https://workspace.who.int/sites/att/default.aspx
NRA Database Management: https://workspace.who.int/sites/nra_database/default.aspx
Related Databases
Thank You
