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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/RSS. Presented by: Dr Alireza Khadem khadembroojerdia@who.int. Outline. Background

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WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE

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  1. 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 khadembroojerdia@who.int

  2. Outline • Background • WHO policy to strengthen NRAs in the area of vaccines • Capacity building process • Institutional Development Plan (IDP) • China success story • Strengthening the Regulatory Inspection Function • Parallel review • Global Learning Opportunities (GLO) • Facts and Figures • NRA Intelligence system

  3. 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. 2004 1987 1996

  4. WHO NRA 5 step capacity building Functional NRA 2 1 5 3 4 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. Re-assessment Every 2-5 years Self assessment for planning formal assessment Revision of indicators & assessment process (Every 2-3 years) Harmonization of tools

  5. Capacity Building Process

  6. Institutional Development Plan(IDP)

  7. China: The Success Story Functional NRA, after assessment in Dec 2010 NRA Re-Assessment NRA Assessment IDP IDP Mar/2011 Oct/2013 Q2/2014 2005

  8. Raising inspections performances:enforcement, competencies and skills Functional NRA 2 1 5 3 4 Develop a response to address the gaps of both inspectorates and inspectors Performance evaluation of GMP inspectorate (GAP analysis) Performance evaluation of regulatory inspectors +

  9. Regulatory InspectionStrengthening Process • 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

  10. 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

  11. Activities conducted: 2010 to 2013

  12. Parallel review: steps WHO receive a request from a "developing NRA" WHO inform both NRAs About the process and request confidentiality agreement & Commitment in writing WHO Seek for a "leading NRA" 2nd Training on vaccine evaluation 1st training on vaccine evaluation Principles and process Parallel review conducted 1- 3 months 3-6 months

  13. 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)

  14. Global Learning Opportunities AUTHENTIC E-LEARNING • 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 http://epela.net

  15. 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

  16. 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

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

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

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

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

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

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

  23. Training *National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

  24. Nra intelligence system

  25. Database modules • NRA SharePoint • NRA Planning/Monitoring System & Expert Modules • NRA Assessment Modules • Lot Release & Vaccine • NRA Training Database • GMP Database

  26. 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, Lotrelease, vaccine doses.

  27. Database modules GMP

  28. Related Databases • NRA SharePoint: https://workspace.who.int/sites/att/default.aspx • NRA Database Management: https://workspace.who.int/sites/nra_database/default.aspx

  29. Thank You

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