Consultant for Strengthening of the Pharmaceutical Systems in the Greater Mekong Sub-Region

Background

Availability of quality antimalarials is essential to establish effective and safe treatment of malaria and prevent spread of multidrug-resistant form of malaria in the Greater Mekong Sub-region (GMS). Given the dynamic nature of malaria transmission, it is necessary to strengthen the pharmaceutical systems to ensure timely access to quality, safe and effective artemisinin-based combination therapy (ACT) across the region.

The WHO Regional Office for the Western Pacific (WPRO) has supported collaborative efforts of the five Greater Mekong Sub-region countries, partners and national stakeholders to address the critical challenges faced by the national malaria control programs. The work plan for the pharmaceutical component includes intervention to improve access to quality-assured essential medicines and medical products in both, public and private sector.

Marketing authorization involves scientific review of evidence-based study that meets international standards and procedure. A regulatory agency with limited resources and poor technical guidelines may result to inconsistent evaluation and will lack scientific review of the critical parameters in the product dossier.

WPRO is initiating the development of training module to support the technical capacity building of the national medicines regulatory authorities’ (NMRAs) evaluators of pharmaceutical product dossier for marketing authorization (MA).   This is to ensure that the pharmaceutical product dossiers are evaluated in a consistent and transparent manner following international standards and scientific guidelines to minimize the delay in drug approvals.

Purpose/Specific Objective of the Activity and Target Audience

The overall objective of this technical assistance is to develop a comprehensive training module that can be used to build competencies of NMRAs on technical evaluation of a pharmaceutical product dossier application for MA. Specifically, this undertaking is aimed to design a training program composed of course curriculum, lectures and hands-on training modules covering the key concepts of ASEAN Common Technical Dossier and ASEAN Common Technical Requirements (ACTD ACTR) and other international technical guidelines. 

Description of activities to be carried out

Under the supervision and guidance of the Technical Officer for Pharmaceuticals, EMT, DHS at the WHO Regional Office for the Western Pacific, the contractor will:

• design a training course on the evaluation of pharmaceutical product dossier for marketing authorization intended for NMRAs technical evaluators; and
• develop a  teaching-learning materials (power-point slides, trainers guide, evaluation tools, hands-on training modules, participant workbook and additional materials as needed) that will guide the facilitators and resource persons in the delivery of the training and optimize learning of participants.

Method(s) to carry out the activity

The contractor should work with WHO regional office focal points and technical experts on the evaluation of a pharmaceutical product dossier. The core elements and content of the training package should emphasize the key concepts of ACTD ACTR and other international technical guidelines. 

Qualifications and Experience

The contractor should be an institution with the required expertise and experience to implement project on of malaria commodities or other public health related programs in the developing countries.

Technical Skills and knowledge/Skills

The contractor should have at least five years of professional experience in pharmaceutical related fields, such as medicines regulation of health products and at least three years’ experience at international level. The contractor should have a sound knowledge of the process, challenges and implementation of policies at national or sub-national level in the GMS Countries.

Languages

Must be fluent in reading, writing and speaking in English

Competencies

• Proven experience in designing/developing training materials and educational tools
• Effective organizational, communication, interpersonal and writing skills
• Communicating in a credible and effective way
• Moving forward in a changing environment
• Teamwork
• Producing results

APPLICATIONS

Qualified and interested specialists should submit their CV to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 08 October 2018. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please note that applications may be closed before the indicated closing date if a sufficient number of applications are received.  Only the successful candidates will be contacted.

Please use Tender Notice No. 77740 as subject to all submissions.

[Travel:  For each assignment WHO shall reimburse cost of travel from the place of domicile of the individual to the place of assignment (most direct economy fare)].