The EU Clinical Development Roadmap MasterClass - EU edition

Dr. Leena Zino is a Clinical Development Consultant at DADA, where she leads pharmaceutical safety and efficacy projects and serves as the organization contact for the Middle East region. She holds a Master’s degree in Drug Innovation a Ph.D. in Clinical research where her focus was developing antiretroviral therapies for special patient populations. She is working as a consultant Clinical Development Consultant in multiple companies focusing on clinical trial management, regulatory affairs, and medical writing, including the preparation of clinical and non-clinical overviews and scientific advice applications. She worked with a variety of pharmaceutical products including small-molecules, supplements, and orphan drugs.

Through this masterclass, Dr. Zino helps delegates:
1. Master the European Clinical Roadmap: Gain a structured, high-level understanding of EU approval pathways, regulatory mechanics, and key factors determining market entry success.

2. Evaluate Strategic Regulatory Mechanisms: Understand when and how to leverage key European regulatory tools, including Scientific Advice, Paediatric Investigation Plans (PIPs), and early-access incentives like Orphan Drug Designations (ODD).

3. Navigate Regulatory Scrutiny & Dossier Strategy: Learn how regulators evaluate the benefit-risk balance in clinical data and how to formulate effective response strategies to authority inquiries and source of Major Objections.