Presentation is loading. Please wait.

Presentation is loading. Please wait.

WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE WHO Technical Briefing Seminar on Essential Medicines and Health.

Similar presentations


Presentation on theme: "WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE WHO Technical Briefing Seminar on Essential Medicines and Health."— Presentation transcript:

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

2 | 2 |2 | 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

3 | 3 |3 | 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

4 | 4 |4 | 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 Functional NRA Re-assessment Every 2-5 years Self assessment for planning formal assessment Re-assessment Every 2-5 years Self assessment for planning formal assessment Revision of indicators & assessment process (Every 2-3 years) Harmonizati on of tools Revision of indicators & assessment process (Every 2-3 years) Harmonizati on 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 support through: Global Learning Opportunities (GLO) Technical Support In-country training WHO electronic platform to monitor NRAs information and assessment reports, IDP, training, etc.

5 | 5 |5 | 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

6 | 6 |6 | Institutional Development Plan (IDP)

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

8 | 8 |8 | WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem Functional NRA Coached Audit Basic and Advanced Regulatory Inspection Workshop + technical support + Observed 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

9 | 9 |9 | WHO/ EMP/ Regulatory Systems Strengthening, October 2013, Alireza Khadem Regulatory Inspection Strengthening 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

10 | 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

11 11 | Activities conducted: 2010 to 2013

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

13 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

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

15 | 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 | 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 | 17 | Training *National Control Laboratory **Expanded Programme on Immunization Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

18 | 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 | 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 | 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 | 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 | 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 | 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 | 24 | NRA INTELLIGENCE SYSTEM

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

26 | 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, Lot release, vaccine doses.

27 | 27 | Database modules GMP GMP GMP GMP GMP GMP

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

29 Thank You


Download ppt "WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE WHO Technical Briefing Seminar on Essential Medicines and Health."

Similar presentations


Ads by Google