Consultants - Collaborative Registration Procedure, WPRO/DHS

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Purpose of consultancy  

The Consultant will support Member States activities related to facilitated product introduction mechanisms though reliance, in particular the Collaborative Registration Procedure (CRP) and to build capacity of the marketing authorization function and assessment of marketing authorization applications, according to WHO and international standards. S/he will support national regulatory authorities with implementation of WHO's CRP and with outreach to additional countries, support regional ASEAN joint assessment activities, and Global Health Products Procedures.  

Background  

The WHO Collaborative Registration Procedure (CRP) is a regulatory reliance mechanism that accelerates national registration of WHO‑prequalified and Stringent Regulatory Authority–approved medical products by enabling National Regulatory Authorities (NRAs) to use WHO’s confidential assessment and inspection outcomes, reducing duplication and shortening decision timelines to about 90 days. The CRP addresses limited regulatory capacity in many countries, strengthens marketing authorization systems by promoting good reliance practices, and supports NRAs in implementing efficient, risk‑based evaluation pathways aligned with international standards.

The Consultant will support Member States in activities related to facilitated product introduction mechanisms though reliance, in particular the Collaborative Registration Procedure (CRP) and to build capacity of the marketing authorization function and assessment of marketing authorization applications according to WHO and international standards.

Deliverables

The Consultant is expected to complete the following outputs and deliverables:

Output 1: Advocate and support national regulatory authorities in the region with the implementation of reliance and/or WHO Collaborative Registration Procedure in collaboration with WHO HQ/RPQ REG.

Deliverable 1.1: Provide technical support to countries for an efficient implementation of reliance mechanisms and/or WHO Collaborative Registration Procedure.
Deliverable 1.2: Reply to requests from the national regulatory authority regarding any technical questions on the evaluation or the good manufacturing practices status for a specific product and liaise with WHO HQ, as necessary.
Deliverable 1.3: Facilitate and support the WHO HQ Special Access Programme for training and any needed guidance for countries.
Deliverable 1.4: Support NRAs in development, revision and updating policies, regulations, guidelines and tools to support facilitated product introduction pathways and CRP implementation, in collaboration with WHO HQ.

Output 2:  Follow-up CRP submissions for the countries in the region and help NRAs with any questions for the current 4 participating countries in WPRO (Lao People's Democratic republic, Malaysia, Papua New Guinea and Philippines)

Deliverable 2.1: Support the national regulatory authority in the region with running of CRP.
Deliverable 2.2: For each application, check and confirm with the national regulatory authority if they want to use CRP for this specific application
Deliverable 2.3: Follow-up CRP timelines for application in the region and support the collection of CRP metrics and statistics in the region
Deliverable 2.4: Ensure that the electronic prequalification system (ePQS) for the CRP submissions in the region is up to date and support publication of CRP metrics and information
Deliverable 2.5: Inform WHO HQ of any challenges or difficulties requiring additional support for CRP implementation
Deliverable 2.6: In accordance with WHO Headquarters and Regional Office regulatory systems strengthening programmes, support national regulatory authorities in the Region to develop and strengthen marketing authorization functions, including building capacity for the assessment of marketing authorization applications, using the WHO Global Benchmarking Tool and agreed Institutional Development Plans, in line with international standards.

Output 3:  Support country out-reach for CRP in the region for additional countries.

Deliverable 3.1: In collaboration with WHO HQ and the relevant country office, arrange for outreach to new countries not currently participating in WHO CRP
Deliverable 3.2: Facilitate and support the WHO HQ Special Access Programme for dedicated country or region advocacy workshops on reliance and CRP

Output 4:  Support to regional ASEAN joint assessment and joint activities, and Global Health Products Procedures

Deliverable 4.1: Provide technical support, in collaboration with WHO HQ, for dedicated regional joint assessment or joint activities for any upcoming/ongoing procedure.
Deliverable 4.2: Facilitate and support the use of the Joint Assessment Information Management System.
Deliverable 4.3: Help in collecting metrics and statistics of joint assessment or joint activities in the region
Deliverable 4.4: Support activities for global health products procedures such as EU-M4all with the EMA or Swissmedic Marketing Authorisation for Global Health products for involvement of experts from the national regulatory authorities in the region.

Qualifications, experience, skills and languages

Educational Qualifications:  

Essential: First university degree in pharmaceutical sciences, or related field.
Desirable: Advanced university degree (master’s level or above) in the area of pharmaceuticals/ pharmacology, or a related field.

Experience  

Essential: At least five years of professional experience in regulation of medical products, especially in marketing authorization, and acquired by working in an NRA or a pharmaceutical/biological manufacturer or other relevant institutions.
Proven familiarity with regulatory facilitated pathways and mechanisms, including WHO Collaborative Registration Procedures (CRP).
Experience in facilitating and conducting meetings, workshops, trainings, or other regulatory capacity building activities. 
Experience in preparing technical reports.

Desirable: Experience with ASEAN joint assessments or unilateral reliance procedures would be an advantage.

Skills/Knowledge: 

• Proven ability to handle projects and a sound knowledge in global health matters. 
• Expertise in preparing written reports, communication materials and other documents in English. 
• Good organizational skills.  
• Proven ability to communicate and work in diverse cultural settings, to edit regulatory documents, and to contribute to achieving agreements among different stakeholders on regulatory matters for medical products.  
• Computer proficiency and expertise, particularly with the Office environment (Excel, Word, PowerPoint)

Languages and level required:

Essential: Expert knowledge of English (read, write, speak)

Location

On site: Manila, Philippines

Travel

The Consultant is expected to travel for the CRP advocacy workshop, technical support visit to NRAs and for other relevant meetings.

Additional Information:

•    This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
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•    A written test may be used as a form of screening.
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