Advanced Regulatory Inspection Workshop

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 8. Global Learning Opportunities (GLO) | 9. Facts and Figures 10. NRA Intelligence system 2| 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. | 1987 3| 1996 2004 Bench Marking Development of NRA assessment tool

1 Assessment of NRA 2 Development of Institutional Development Plan (IDP) Providing technical support, Training/Learn ing, networking, 3 4 With or without a road map for prequalification of products WHO support

through: Monitoring progress and impact 5 | Revision of indicators & assessmen t process (Every 2-3 years) Harmonizat 4 | of tools ion 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 Gap analysis IDP Addressing the gaps Assessment A plan for addressing the identified gaps Providing technical support

Training | Monitoring progress and impact 5| IDP follow-up Reassessment Global Learning Opportunities (GLO) In-county workshop Technical Support Institutional Development Plan (IDP) | 6|

China: The Success Story NRA Assessment IDP 2005 7| NRA ReAssessment Functional NRA, after assessment in Dec 2010 IDP | Mar/2011 Oct/2013 Q2/2014 Bench Marking Developm ent of

NRA assessme nt tool Assessme nt of NRA 1 2 | Providing technical support, Training/L earning, networkin g, 3 + Observ ed Audit Performance evaluation of GMP

inspectorate (GAP analysis) 8| Developm ent of Institution al Developm ent Plan (IDP) + Basic and Advanced Regulator y Inspectio n Workshop + technical Performance support Monitorin g progress

and impact 4 5 Functional NRA Raising inspections performances: enforcement, competencies and skills Coach ed Audit evaluation of regulatory inspectors WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem 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 A plan for addressing the identified gaps Providing technical support Training | Monitoring progress and impact 9| IDP follow-up

Reassessment Observed audit Global Learning Opportunitie s (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 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 10 | 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 China China 11 | 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

WHO receive receive aa request request from from aa "developing "developing NRA" NRA" WHO WHO inform inform both both NRAs NRAs About About the the process process and and request request &&confidentiality confidentiality agreement agreement WHO WHO Seek Seek for for Commitment in writing Commitment in writing

aa "leading "leading NRA" NRA" 11stst training training on on vaccine vaccine evaluation evaluation Principles Principles and and process process | nd Training 22nd Training on on vaccine vaccine evaluation evaluation Parallel review conducted months 3- 1 12 |

months 3-6 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 | *Global Training Network, **National Control Laboratory, Expanded Programme on Immunization 15 | Vaccine Manufacturers Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | *Global Training Network, **National Control Laboratory, Expanded Programme on Immunization 16 | Vaccine Manufacturers

Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | *National Control Laboratory 17 | **Expanded Programme on Immunization Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers 18 | Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | 19 | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers

Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | 20 | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Training | 21 | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers Training | 22 | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers Training

| 23 | *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers NRA INTELLIGENCE SYSTEM | 24 | Database modules NRA SharePoint NRA Planning/Monitoring System & Expert Modules NRA Assessment Modules Lot Release & Vaccine NRA Training Database | GMP Database 25 | 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 | Monitoring progress and impact and follow up: IDP, Lot release, vaccine doses. 26 | Database modules Certifi Certifi cate cate Vacci ne Lot Relea se GMP Trainin

g g Vaccin Vaccin e e W W o o rr k k p p la la n | Acti vity NRA Planni ng

Activitie Activitie s s Assess Assess ment ment C V Expert DB I V B Train ees ees 27 | NRA Training Train

Train ing ing Cent Cent ers NRA country Profile NRA Assessmen NRA Tea m t I D P Generi c tools Related Databases NRA SharePoint: https:// workspace.who.int/sites/att/default.aspx

NRA Database Management: https:// workspace.who.int/sites/nra_database/default.aspx | 28 | Thank You

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