Microscope

BERC-AFRICA
WORK PACKAGES

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01

PROJECT MANAGEMENT AND COORDINATION.

This encompasses all activities geared towards coordination of technical, financial and administrative issues of the project.

 

This Work Package is to be led by the Food and Drugs Authority (FDA) and expected to span from Year 1 to 3.

 

The objectives of this package are to: 

  1. Coordinate activities to develop a project management strategy

  2. Ensure the implementation and integration of all work packages 

  3. Ensure proper coordination of all partners and collaborators 

  4. Coordinate all SC meetings, including Kick-off and Closure meetings 

  5. Effectively monitor timelines set for deliverables and milestones and objectives of the entire project 

02

RCORE FELLOWSHIP TRAINING IN CLINICAL TRIALS. 

This is a 4-week intensive theoretical and practical training for 10 African regulators. This session would be modeled after the FDA’s well acclaimed RCORE trainings and would include for the first time, regulators from francophone countries.

 

The work package is to be led by the FDA with support from the University of Ghana School of Public Health (UG SPH) in year 2 of the project. 

 

The main objectives of this package are: 

  1. The participants will have hands-on experience on evaluation of Clinical Trial Applications and GCP inspections by using AVAREF templates, RCORE Training manual. 

  2. Observe how the FDA engages external experts on issues related to clinical trials during Technical Advisory Committee meetings 

  3. The establishment of a platform for regulators to share ideas, knowledge and experiences over the years. 

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03

TRAINING AND MOBILITY ACTIONS FOR REGULATORY OFFICERS IN AFRICA. 

This package includes three (3) short courses for regulators (trainers) involved in RCORE training as well as those responsible for assessment of clinical trial application related documents in Ghana and some African countries:

 

This work package is to be led by Coalition for Epidemic Preparedness Innovation (CEPI) with support from FDA Ghana.

The trainings to be completed are: 

  • Introductory course in Epidemiology and Medical Statistics for 1 regulator 

  • Pre-Clinical and First in Human Studies (FIH) and Complex/Adaptive study designs training for 8 - 10 regulators  

  • Essentials of clinical trials or Systematic Reviews and Meta-Analysis for 2 regulators 

 

The main objectives are to: 

  1. Build capacity to enhance output in regulation of clinical trials in Africa especially FIH, complex and adaptive studies

  2. Provide mentorship and training for RCORE trainers and those responsible for CT Application evaluation in Ghana 

04

REGULATORY ATTACHMENT AT PAUL EHRLICH INSTITUT.

This package involves a 45-day regulatory attachment of two (2) regulators at PEI.

The attachment will be in the form of internal seminars, lectures, hands-on activities at the different departments in the host institution. 

 

This work package is to be led by Paul Ehrlich Institut (PEI) with support from FDA Ghana. 

The main objectives of this package are: 

  1. Enhance regulatory skills and knowledge in the area of Clinical Trial Applications assessment and monitoring benefit-risk balance of vaccines and biologics. 

  2. Provide mentorship and continuing professional development for regulators involved in the evaluation of Clinical Trial Applications. 

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