e-drug
[Top] [All Lists]

[e-drug] WHO - Call for consultants to support Collaborative Registration Procedure (two positions) - deadline 28 January 2022

E-DRUG: Call for consultants: WHO Consultancy to support Collaborative 
Registration Procedure (CRP) - two positions.
----------------------------------------------------------------------------

Dear colleagues,

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. 

Consultants profile:

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 
building activities. 
- 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 
new platform. 
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 
to CRP. 

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 
Secretariat.

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: cabacom@who.int
- Manager: Dr Samvel Azatyan, Team Lead, RCN. Email: azatyans@who.int

The deadline for applications is 28 January 2022.

Kind Regards,

Dr Samvel AZATYAN
Team Lead
Regulatory Convergence and Networks [RCN]
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
World Health Organization
Geneva, Switzerland
Web: www.who.int/medicines/en/
"AZATYAN, Samvel" <azatyans@who.int>
<Prev in Thread] Current Thread [Next in Thread>
  • [e-drug] WHO - Call for consultants to support Collaborative Registration Procedure (two positions) - deadline 28 January 2022, AZATYAN, Samvel <=