E-DRUG: Call for consultants: WHO Consultancy to support Collaborative
Registration Procedure (CRP) - two positions.
WHO is seeking experienced consultants to help our Facilitated Product
Introduction (FPI) Team in Geneva to advance the work with our Member States
and other partners in improving access to essential medical products through
implementation of Collaborative Registration Procedure (CRP) and other
facilitated product introduction pathways.
With the aim to respond to public health needs, WHO has developed collaborative
procedures to accelerate the assessment and approval of medical products by
resource-limited authorities, by providing them with access to the outcomes of
scientific assessments done by trusted parties. The WHO Collaborative
Registration Procedure (CRP) provides a tool and mechanism where National
Regulatory Authorities (NRAs) have access to assessments and inspection reports
of medical products performed by reference authorities/institutions following
stringent and international standards. The CRP involves the collaboration
between NRAs, reference authorities or institutions and pharmaceutical
companies to facilitate and accelerate the registration of medical products.
Activities related to facilitated regulatory pathways and collaborative
processes that support the approval of quality-assured medical products by
countries are coordinated within the Regulation and Safety Unit (REG) by the
Facilitated Product Introduction (FPI) team. To streamline this work WHO will
be undertaking a number of activities and would need 2 experienced consultants
to provide sustained advice and coordination of work that will be conducted
with NRAs in our Member States aiming to support the FPI Team with activities
related to facilitated products introduction mechanisms.
The consultants must meet the following requirements:
- First university degree in pharmaceutical sciences, or related field.
Advanced university degree (Master's level or above) in the area of
pharmaceuticals/pharmacology or related field.
- At least 7 years of professional experience of working in the area of
regulation of medical products and acquired by working in an NRA or a
pharmaceutical /biological manufacturer or other relevant institution such as
Academia, Foundations or Associations. At least 7 years of experience in
regulatory functions and processes.
- Proven familiarity with regulatory facilitated or expedited pathways and
mechanisms, including WHO Collaborative Registration Procedures (WHO CRP).
- Proven Project management skills and experience in organizing, facilitating
and conducting meetings, workshops, trainings, or other regulatory capacity
- Advanced experience in preparing written reports, communication materials,
and other documents (in English).
- Fluent in English, written and spoken.
Nature and objectives of the work to be performed:
Under the supervision of the Responsible Technical Officer and Team Lead of
FPI, consultants will undertake the following work:
1. Assist with project management of CRP cases/submissions. This may include
handling and monitoring CRP cases and requests, revising respective forms and
agreements, updating the databases and platforms with current status and
documentation, as well as, performing other related tasks.
2. Support the implementation of FPI strategy plan to expand the use of CRP by
all stakeholders. Related tasks may include communication and interactions with
new target NRAs and applicants, preparation of meetings with stakeholders for
raising awareness and to provide clarity on the procedures, as well as the
development of communication materials for CRP.
3. Support with migration of existing CRP data into ePQS platform (new
electronic system to handle CRP cases). Assist in the transition of CRP to the
4. Support the organization of meetings with relevant stakeholders, workshops,
trainings, webinars or other capacity building activity on regulatory
facilitated pathways and mechanisms, including WHO CRP. Also, support with the
organizations of CRP annual meeting.
5. Assist the Technical Officers in FPI Team in developing communication and
capacity building materials, technical guidance and procedures, written and
statistics reports, memos and presentations on CRP related matters, as needed.
6. Assist the Technical Officers in FPI Team in any other relevant task related
Contract dates: 11 months, starting in February 2022.
Location of work:
This assignment is home based.
Only selected candidates will be contacted (individually) by the WHO
Curriculum vitae should be submitted to WHO/RPQ/REG/FPI by electronic mail with
the subject of
"Call for consultant RPQ/REG/FPI/CRP"
to the following contacts:
- Responsible Technical Officer: Dr Mariana Roldao Santos, Technical Officer,
FPI. Email: email@example.com
- Manager: Dr Samvel Azatyan, Team Lead, RCN. Email: firstname.lastname@example.org
The deadline for applications is 28 January 2022.
Dr Samvel AZATYAN
Regulatory Convergence and Networks [RCN]
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
World Health Organization
"AZATYAN, Samvel" <email@example.com>