On September 18, 2018, Aptar Pharma will host a live webinar to provide insight into how the FDA’s 2018 guidance affects future Combination Product submissions for respiratory and nasal drug products, specifically DPIs, pMDIs, and Nasal Sprays.
Aimed at professionals working in drug development, packaging, business development, CMC and regulatory affairs, this free webinar will be hosted by Aptar Pharma’s Wendy Bolf, Regulatory Affairs Manager and Badre Hammond, Associate Director, Market Development, and will offer guidance on optimal approaches to help secure approval in this changing and challenging regulatory landscape.
The following key topics will be covered:
- The Basics – medical device, combination product, and packaging components
- NDA/ANDA submissions: regulatory pathway review for Combination Products
- Human Factor studies in the context of Combination Products
- Clarifying expectations: Sponsor, device supplier and regulators
“Decoding the FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs and Nasal Sprays” takes place on September 18, 2018 at 15.00 GMT/10.00 EST
Register for the webinar: Aptar Pharma provides guidance on FDA regulatory framework for OINDPs.