Ebenezer Doku | Regulatory Affairs Lead
Roche products Ghana Ltd.
Ebenezer Doku is a Regulatory Affairs Professional with over 12 years of expertise spanning pharmaceutical manufacturing quality systems and global regulatory strategy. Specializing in emerging markets, he focuses on lifecycle management, dossier optimization, and health authority negotiations. Ebenezer is a strong advocate for regulatory modernization, actively championing the adoption of WHO aligned regulatory reliance pathways to accelerate patient access to advanced biological therapies while regional capacities mature.
Appearances:
Festival of Biologics Day 2 @ 14:50
Regulatory Reliance as a Catalyst for Advanced Therapy Access in Emerging Markets
As the global landscape of advanced therapies evolves, many regulatory authorities in emerging markets face the challenge of balancing rigorous safety assessments with the urgent need for patient access. This presentation explores how regulatory reliance pathways, where authorities leverage the assessment work of mature agencies can serve as a critical bridge. We will examine how this strategy enables patients to receive life-saving treatments while providing emerging agencies the time, framework, and collaboration opportunities needed to build their own robust, sustainable regulatory capacities.
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