Consultancy to Review the Existing Regional Centres of Regulatory Excellence (RCORES) Body of Knowledge for Regulatory Professionals and Assess the Existing Regulatory Science Curricula

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Tender Organisation:

AFRICAN UNION DEVELOPMENT AGENCY – NEW PARTNERSHIP FOR AFRICA’S DEVELOPMENT (AUDA-NEPAD)

Tender Sector:

Consultancy

Tender Service:

Worldwide

Tender Region:

African

Tender Country:

South Africa

Tender CPV:

79416202 : consultancy services

Tender Document Type:

Tender Notice

Tender Description:

Tenders are invited for Consultancy to Review the Existing Regional Centres of Regulatory Excellence (RCORES) Body of Knowledge for Regulatory Professionals and Assess the Existing Regulatory Science Curricula. Closing Date: Wednesday, May 17, 2023 - 14:30 Sector: Research, Consultancy and Professional Services Description: Consultancy to review the existing regional centres of regulatory excellence (RCORES) body of knowledge for regulatory professionals and assess the existing regulatory science curricula Tender number: 38/AUDA/DPDC/HCID/ICS/2023 Closing date and time: May 17th, 2023 at 14:30 hours 1. INTRODUCTION The availability of qualified and experienced regulatory professionals for medical products in Africa is severely limited. The causes are multi-faceted from an underdeveloped pharmaceutical and biotech industry, constraints in the supply side, i.e., too few academic programs including at postgraduate levels and inadequate numbers of graduates with relevant academic qualifications, for instance, physicians and pharmacists, to agency-related constraints like inadequate financing, and ability to attract, recruit and retain qualified and experienced personnel. There is a mismatch in the continent between the work and the required skill-set consistent with international best practices in many cases. Therefore, a critical mass of well-trained and qualified regulatory science professionals is imperative if the continent is to make meaningful progress in ensuring adequate regulatory oversight over all relevant medical products to protect and promote public health. 2. OBJECTIVES OF THE ASSIGNMENT The AUDA-NEPAD is looking for a consultant to support the AMRH Initiative to strengthen regulatory capacity strengthening programme building on the efforts of the RCOREs. The consultant will also support the establishment of a mechanism to achieve a common competency and qualifications framework, a common training programme offered through designated partner institutions with a standard or common exam, and the award of an internationally recognized professional qualification in regulatory sciences in Africa. This will inform process of establishing a college or an institute which will be key in addressing the human resource gap. The consultant must be knowledgeable in the regulation of medical products and having experience in establishing and or managing institution for qualification and accreditation of professionals and or establishing international associations of professionals. S/he will be responsible for supporting the AMRH in the execution of the work plan for establishment of college of regulatory science professionals. Specifically the consultancy has the following objectives: a. To conduct a desk review of the existing regulatory science courses on the continent beyond RCOREs including the scope, the type, the duration, and the certification scheme b. Review existing RCOREs body of knowledge for regulatory professionals. c. Assess the existing regulatory science curricula to identify gaps and propose options for strengthening. d. To develop a white paper including options analysis for the establishment of the African College of Regulatory Science Professionals for Stakeholders Consultations e. To support the implementation and management of the work plan for the establishment of the College. f. To review the existing AMRH regulatory science professionals fellowship programmes Interested consultants may obtain further information from the address listed below. All Expression of Interests should be sent electronically to email listed below. 11. Expressions of interest must be delivered to the address below by email on or before May 17th, 2023 14:30 hours (South African Time). All EOI’s must be marked “38/AUDA/DPDC/HCID/ICS/2023 – CONSULTANCY TO REVIEW THE EXISTING RCORES BODY OF KNOWLEDGE FOR REGULATORY PROFESSIONALS AND ASSESS THE EXISTING REGULATORY SCIENCE CURRICULA” in the subject line of the email. The Chairperson Internal Procurement Committee (IPC) AUDA-NEPAD 230, 15th Road, P. O. Box 218 Midrand, 1685 Johannesburg, South Africa Email: procurement@nepad.org & copy ngonik@nepad.org Attention of: Head of Procurement Division see documents for more details see: https://www.sa-tenders.co.za/sites/default/files/reoi_consultancy_to_rev... https://www.sa-tenders.co.za/sites/default/files/terms_of_reference_-_co... Attachments:  reoi_consultancy_to_review_the_existing_rcores_body_of_knowledge_for_regulatory_professionals_and_assess_the_existing_regulatory_science_curricula.pdf terms_of_reference_-_consultancy_to_review_the_existing_rcores_body_of_knowledge_for_regulatory_professionals_and_assess_the_existing_regulatory_science_curricula.pdf

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