HAGIT

I was excited to lead the workshop on IND requirements at the RAPS (Regulatory Affairs Professionals) Convergence in Montreal. Together with Dr. Tyler C. Vandivort and Ms. Lina Jamis, we navigated the CMC, non-clinical and clinical requirements for IND submissions, as well as the strategy for a successful pre-IND meeting. The RAPS Convergence is one of the largest regulatory conferences, with thousands of participants from all over the world, including many lectures from representatives of FDA, EMA, Health Canada and other Health Authorities. I highly recommend this annual event for RA professionals... Regulatory affairs consulting to the biopharmaeutical industry, specialized in biologics, drugs and combination products. Experienced in FDA, EMA, IMOH ROW submissions.