IPA invites you to attend the 3 days comprehensive & Interactive course with discussion on Advanced Regulatory Affairs, to be held on January 24-26, 2017 in Toronto.
Regulatory Affairs is crucial to the successful development, approval, and marketing of pharmaceutical products. The first day and a half will address the Drug Development, Regulatory Agency Contact Points, NDA submissions, NDA Supplements and Electronic submissions (eCTD).
The second half of the course will address the expectations of a regulatory leader and how to develop and implement those skills. Essential regulatory strategies and approval pathways will be discussed, including the requirements and pros and cons of each. Case studies will be reviewed. Creating a risk assessment and associated mitigations will be discussed and applied in a practicum.