Details
Mission and objectives
To promote health, keep the world safe and serve the vulnerable, with measurable impact for people at country level. The organization’s strategic priorities are to ensure healthy lives and well-being for all at all ages: achieving universal health coverage, addressing health emergencies and promoting healthier populations.
Context
Support Member States in activities related to facilitated product introduction mechanisms though reliance, in particular the Collaborative Registration Procedure (CRP) and support Member States and Regional Economic Communities through the regulatory harmonization initiatives, to build capacity of the marketing authorization function and assessment of marketing authorization applications according to WHO and international standards.
Task description
Under the supervision of the World Health Organization (WHO) Representative, the volunteer will undertake the following tasks:
1. Support the national regulatory authorities (NRAs) in the region with the implementation of reliance and WHO Collaborative Registration Procedure (CRP) in collaboration with WHO Headquarters (WHO HQ)/Regulatory Procedures and Quality (RPQ) REG
• Provide technical support to countries for efficient implementation of reliance mechanisms and WHO Collaborative Registration Procedure.
• Reply to requests from the NRAs regarding any technical questions on the evaluation or the good manufacturing practices status for a specific product and liaise with WHO HQ, as necessary.
• Facilitate and support the WHO HQ Special Access Programme for training and any needed guidance for countries.
• Support CRP-participating NRAs in the development, revision, and updating of policies, regulations, guidelines, and tools to support facilitated product introduction pathways and CRP implementation, in collaboration with WHO HQ.
2. Follow-up CRP submissions for the countries in the region and assist NRAs with any questions
• Ensure the day-to-day running of CRP with the NRAs in the region.
• For each application, check and confirm with the NRA if they want to use CRP for the specific application.
• Follow up on CRP timelines for applications in the region. Help in collecting metrics and statistics of CRP in the region.
• Keep the electronic prequalification system (ePQS) up to date for the CRP submissions in the region and support publication of CRP metrics and information.
• Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation.
3. Support country reach-out for CRP in the region
• In collaboration with WHO HQ and the relevant country office, arrange outreach to new countries not currently participating in WHO CRP.
• Facilitate and support the WHO HQ Special Access Programme for dedicated country or regional advocacy workshops on reliance and CRP.
4. Support to regional joint assessments and other joint activities
• Provide technical support, in collaboration with WHO HQ, for dedicated regional joint assessments or other joint activities.
• Help in collecting metrics and statistics of joint assessments or other joint activities in the region.
5. Support with Global Health Products procedures and involvement of NRAs in the region
• Support activities for global health product procedures such as EU-M4all with the European Medicines Agency (EMA), or Swissmedic Marketing Authorization for Global Health products including involvement of experts from the NRAs in the region.
6. Support the NRAs in the region to build capacity for the marketing authorization function and assessment of marketing authorization applications
• In accordance with WHO’s regulatory system strengthening programme, the WHO Global Benchmarking Tool, and the Institutional Development Plans developed, support NRAs in the region to develop and strengthen the marketing authorization function and build capacity for assessment of marketing authorization applications in accordance with international standards.
• In collaboration with WHO HQ, support the design and implementation of training on abridged reviews and product verification by NRAs participating in CRP and other facilitated pathways.
• Provide technical support to Member States.
7. Take the lead in coordinating and engaging relevant technical experts, as required, to support the effective implementation of planned activities
1. Support the national regulatory authorities (NRAs) in the region with the implementation of reliance and WHO Collaborative Registration Procedure (CRP) in collaboration with WHO Headquarters (WHO HQ)/Regulatory Procedures and Quality (RPQ) REG
• Provide technical support to countries for efficient implementation of reliance mechanisms and WHO Collaborative Registration Procedure.
• Reply to requests from the NRAs regarding any technical questions on the evaluation or the good manufacturing practices status for a specific product and liaise with WHO HQ, as necessary.
• Facilitate and support the WHO HQ Special Access Programme for training and any needed guidance for countries.
• Support CRP-participating NRAs in the development, revision, and updating of policies, regulations, guidelines, and tools to support facilitated product introduction pathways and CRP implementation, in collaboration with WHO HQ.
2. Follow-up CRP submissions for the countries in the region and assist NRAs with any questions
• Ensure the day-to-day running of CRP with the NRAs in the region.
• For each application, check and confirm with the NRA if they want to use CRP for the specific application.
• Follow up on CRP timelines for applications in the region. Help in collecting metrics and statistics of CRP in the region.
• Keep the electronic prequalification system (ePQS) up to date for the CRP submissions in the region and support publication of CRP metrics and information.
• Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation.
3. Support country reach-out for CRP in the region
• In collaboration with WHO HQ and the relevant country office, arrange outreach to new countries not currently participating in WHO CRP.
• Facilitate and support the WHO HQ Special Access Programme for dedicated country or regional advocacy workshops on reliance and CRP.
4. Support to regional joint assessments and other joint activities
• Provide technical support, in collaboration with WHO HQ, for dedicated regional joint assessments or other joint activities.
• Help in collecting metrics and statistics of joint assessments or other joint activities in the region.
5. Support with Global Health Products procedures and involvement of NRAs in the region
• Support activities for global health product procedures such as EU-M4all with the European Medicines Agency (EMA), or Swissmedic Marketing Authorization for Global Health products including involvement of experts from the NRAs in the region.
6. Support the NRAs in the region to build capacity for the marketing authorization function and assessment of marketing authorization applications
• In accordance with WHO’s regulatory system strengthening programme, the WHO Global Benchmarking Tool, and the Institutional Development Plans developed, support NRAs in the region to develop and strengthen the marketing authorization function and build capacity for assessment of marketing authorization applications in accordance with international standards.
• In collaboration with WHO HQ, support the design and implementation of training on abridged reviews and product verification by NRAs participating in CRP and other facilitated pathways.
• Provide technical support to Member States.
7. Take the lead in coordinating and engaging relevant technical experts, as required, to support the effective implementation of planned activities
At Impactpool we do our best to provide you the most accurate info, but closing dates may be wrong on our site. Please check on the recruiting organization's page for the exact info. Candidates are responsible for complying with deadlines and are encouraged to submit applications well ahead.
Before applying, please make sure that you have read the requirements for the position and that you qualify. Applications from non-qualifying applicants will most likely be discarded by the recruiting manager.