Module 6

04/10/2024

Role of Key Opinion Leaders in Drug Development

A Key Opinion Leader (KOL) in the pharma industry is an influential researcher or physician held in high regard by their colleagues Play a critical role in the life sciences industry to provide invaluable insights to help navigate the regulatory landscape and bring credibility during the marketing phase

KOL role to pharmaceutical companies: • Advise on clinical study design • Clinical relevance of outcomes • Investigators • Credibility to development programme • Act as speakers at conferences and authors of published papers • Assist with agency questions • Participate in oral explanations, discussion meetings with agencies • Real-life medical context • Assist in launch of the product

The Organisation for Professionals in Regulatory Affairs

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Role of Key Opinion Leaders in Drug Development

Role of KOL to EMA

• Participate in oral explanations, discussion meetings with agencies, Scientific

Advisory Group (SAG) or Ad Hoc Expert Group (AHEG) meetings

• Real-life medical context of the disease / condition

• Design of clinical studies

• Assist in the definition of a clinically relevant benefit

• Advise on interventions to reduce the risk of the product

The Organisation for Professionals in Regulatory Affairs

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