The regulatory affairs team is critical to CEPI’s mission and has two key components:
Provide regulatory support and oversight to our funded programmes, ensuring that developers have built regulatory strategies that will meet the programme’s objectives and ultimately achieve regulatory approvals;
Shape the regulatory environment by engaging with regulators worldwide, identifying regulatory challenges and bottlenecks; building solutions and driving the regulatory community to alignment.
The regulatory function will work across multiple workstreams in connection with CEPI 2.0 as well as identify opportunities for accelerating vaccine development and working with local and regional regulators to ensure greater epidemic preparedness.
Training networks for sustained capacity building related to ethics, regulatory and pharmacovigilance” in sub-Saharan Africa Call for Proposal
EDCTP3 and CEPI as contributing partner have co-launched a Call for Proposal for “Training networks for sustained capacity building related to ethics, regulatory and pharmacovigilance” in sub-Saharan Africa. The deadline for application is 2 September 2026. More than 10 projects will be supported (around EUR 1.5M per project).
Proposed projects will be expected to increase regulatory and research ethics oversight capacity of national and regional authorities in SSA to operate at WHO maturity level 3 for clinical trial, registration and/or PV for medical products (therapeutics/vaccines). Proposals are additionally expected to lead to at least two of the following outcomes:
Improved digital infrastructure including emerging digital tech (i.e. AI, big data) for assessment of clinical trials by RECs and regulatory authorities in SSA.
Availability and accelerated use of digital tools and data analytics for real-time safety data monitoring, reporting, and timely PV data sharing across countries in SSA and globally (pre- and post-authorisation PV processes).
Harmonize and streamline research ethics processes within countries to better coordinate multi-centre trial reviews.
Greater alignment and cooperation across countries in SSA regarding global standards in ethics, regulatory and PV.
Greater preparedness for emergency use authorization (incl MEURI) through implementation of accelerated and harmonized processes.
