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[e-drug] Call for consultant - WHO - to support the work of ASEAN Joint Assessment Coordination Group (JACG) - deadline 14 February 2020

E-DRUG: Call for consultant - WHO - to support the work of ASEAN Joint 
Assessment Coordination Group (JACG) - deadline 14 February 2020
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Call for consultant: WHO Consultancy to support the work of ASEAN Joint 
Assessment Coordination Group (JACG)  

Dear colleagues,

WHO is supporting the Association of South East Asian Nations (ASEAN) 
Pharmaceutical Products Working Group (PPWG) Advisory Committee on Standards 
and Quality to implement ASEAN harmonized requirements for registration of 
medical products. 

This work is part of the overall process started by ASEAN member countries to 
harmonize their regulatory requirements for medical products and strengthen 
cooperation among national regulatory authorities in view of ensuring access to 
good quality, effective medicines for all ASEAN citizens within the context of 
the ASEAN Economic Community principles. To streamline this process WHO will be 
undertaking a number of activities as requested by the ASEAN PPWG and would 
need 2 experienced consultants to provide sustained advice and coordination of 
work that will be conducted with NRAs in ASEAN countries, and specifically to 
support the work of ASEAN Joint Assessment Coordination Group (JACG). One of 
the proposed consultants (a) will be based in an ASEAN Member States and the 
other one (b) will be based in Geneva or elsewhere in Europe. 

Consultants profile:
The consultant must meet the following requirements:
- For the consultant (a) - at least 10 years of work experience in a senior 
position in the National Medicines Regulatory Authority of an ASEAN Member 
State;
- For the consultant (b) - at least 10 years of national and international 
regulatory experience in a senior position. WHO experience is an asset;
- Proven familiarity with ASEAN medicines regulatory procedures and, in 
particular, the ASEAN Joint Assessments Procedure;
- Proven ability to interact with international organizations;
- Proven ability to lead meeting discussions, edit regulatory documents, and 
contribute to achieving agreements among different regulatory authorities;
- Fluent in English, written and spoken. 

Nature and objectives of the work to be performed:
Under the supervision of Team Lead, Regulatory Convergence and Networks and in 
close coordination with PPWG Chairperson and ASEAN Secretariat, consultants 
will undertake the following work:
- Draft and assist PPWG Chairperson to revise procedures for Joint Assessments 
based on input received from ASEAN member states and industry associations.
Action required: drafting documents, proactively seek feedback engage in 
discussion by emails and telephone conversations, editing documents to 
accommodate views, producing a final draft for meeting discussion.

-  Coordinate discussion of documents within the Joint Assessments Coordination 
Group (JACG) and PPWG Heads of Delegation to facilitate achieving progress in 
the implementation of ASEAN Joint Assessment work.
Action required: proactively seek feedback, engage in discussion by emails and 
telephone conversations, editing documents to accommodate views.
- Assist ASEAN JACG to identify candidate medicines for joint assessments and 
facilitate contacts between ASEAN NRAs, interested applicants and reference 
NRAs.

Action required: discussing in person and exchanging correspondence with ASEAN 
Secretariat, WHO, and PPWG-designated focal points. 

-  Organize and facilitate JACG meetings and Joint Assessment technical review 
sessions, including in the context of WHO Collaborative Registration Procedure.
Action required: discussing in person and exchanging correspondence with ASEAN 
Secretariat, WHO, PPWG-designated focal points, reference NRAs, and designated 
assessors. 

Deliverables:
-  Documents describing procedures and model correspondence related to Joint 
Assessments of Applications for Drug registration, finalized.
- Organize, attend and facilitate meetings.  
- Project progress reports to be submitted at appropriate interval as requested 
by WHO.

Time frames:
Contract dates: 6 months contracts during March 2020 to October 2020.

Location of work:
The consultant (a) shall be based in one of the ASEAN Member States and will 
cover the whole ASEAN, it is therefore interregional.
The consultant (b) shall be based outside ASEAN region - either in Geneva or 
elsewhere in Europe.

Only selected candidates will be contacted (individually) by the WHO 
Secretariat. 

Curriculum vitae should be submitted to WHO/RPQ/REG by electronic mail to 
azatyans@who.int with the following title: "Call for consultant RPQ/REG/ASEAN" 

The deadline for applications is 14 February 2020. 

Dr Samvel AZATYAN
Unit Head a.i.
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
Access to Medicines and Health Products [MHP]
World Health Organization
Geneva, Switzerland
Office: +41 (0)22 791 1506
Mobile: +41 (0)79 477 1727Switzerland
E-mail: azatyans@who.int 
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