Embark on a journey through the intricate process of bringing pharmaceutical and biotech products from concept to reality in this enlightening session. Join Shawn Zadeh, seasoned Engineer at Biogen for an insightful session that delves into the intricacies of this journey, drawing from over 14 years of academic and industrial expertise.

Picture this: a groundbreaking drug or biotech innovation is on the brink of changing lives. But before it can reach the hands of patients, it must navigate a labyrinth of regulatory pathways. From crafting meticulous submissions encompassing Chemistry, Manufacturing, and Controls (CMC), to navigating the rigorous processes of Biologics License Applications (BLA), Drug Master Files (DMF), and New Drug Applications (NDA), every step is critical, every detail scrutinized.

As we explore the journey of regulatory approvals, we'll uncover the diverse pathways to regulatory clearance, from pioneering therapies blazing new trails to generic equivalents providing accessible treatments for all. Each approval represents not just a milestone, but a promise of hope for those awaiting life-changing treatments.

But regulatory approval is just the beginning. The true test lies in translating these approvals into robust manufacturing processes that deliver safe, effective formulations for human consumption. Imagine the meticulous design, implementation, and validation of equipment and automation systems, each step informed by rigorous risk assessments to ensure quality and safety at every turn.

Yet, the journey doesn't end there. Once in operation, maintaining compliance with current Good Manufacturing Practices (cGMP) becomes paramount. From upholding the integrity of data to managing change controls seamlessly, companies must navigate a landscape of regulatory commitments with unwavering dedication.

Join us on this immersive journey, where regulatory affairs meet manufacturing expertise, and where innovation converges with diligence. Whether you're a seasoned professional or an eager enthusiast, this session promises to enlighten, inspire, and equip you with the insights needed to navigate the dynamic landscape of pharmaceutical and biotech product development.

June 6, 2024