Biotech Entrepreneurship & Regulatory Affairs

🔍 Overview

This 3-day course introduces the foundations of biotech entrepreneurship with a strong focus on regulatory frameworks and commercialization pathways. Participants will explore key topics such as intellectual property protection, startup business models, and the basics of EMA/FDA regulatory processes.

Real-world case studies and interactive sessions will help participants understand how to navigate clinical trial planning, product development, and biotech innovation strategy.

Designed for aspiring founders, innovators, and researchers aiming to translate science into solutions.

📘 Modules

• Intellectual Property & Licensing
• Biotech Business Models & Startup Strategy
• EMA/FDA Regulation Fundamentals
• Clinical Trial Phases & Regulatory Roadmap