Greetings!
We are hosting a two-hour workshop for professionals working in or alongside the drug submission process. If gaps in your regulatory knowledge are slowing you down, this session is worth your time.
The workshop covers the full New Drug Submission process - from drug development and notice types, through to submission formatting, priority review policy, and the Common Technical Document (CTD). A focused portion addresses eCTD submissions specifically, including where and why applications get screened out before they ever reach review.
It is particularly relevant for regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in the preparation or filing of new drug submissions.
By the end of the session, you will have a clear, working understanding of what a compliant submission looks like, how the approval process is structured, and where most applicants go wrong.
The session will be led by Abdul Hadi Zubair, PMP, Technical Manager - Supplier Quality at Roche and Professor in Quality Assurance and Regulatory Affairs programs. With close to a decade of experience across organizations such as Roche, Bayer, and Elanco, he has been directly involved in the approval and launch of clinical and commercial products, while leading quality systems and ensuring consistent GMP compliance. His experience spans both industry execution and academic instruction, where he regularly trains and mentors professionals in regulatory frameworks, submission strategy, and quality systems.
His background combines strong technical depth with structured project and quality management expertise, supported by certifications in PMP, Lean Six Sigma, and Regulatory Affairs, along with advanced training from the University of Toronto. This allows him to bring not just theory, but real-world insight into how submissions are evaluated, where they fail, and what actually works in practice. |
