Crystal Lake, Illinois, August 27, 2018
Aptar Pharma, a leading drug delivery systems provider, will host a live webinar on September 18, 2018 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.
This new FDA guidance, which was released in April 2018, follows the final FDA Guidance for Combination Products issued in January 2017, which defines a Combination Product as a product composed of two or more different types of medical products (i.e., a combination of a drug, device and/or biological product with one another). There are three types of combinations products: single entity, co-packaged and cross-labelled. The drug applicant therefore needs to demonstrate compliance with all cGMP regulations applicable to each of the constituent parts included in the Combination Product. Hosted by Aptar Pharma’s Wendy Bolf, Regulatory Affairs Manager and Badre Hammond, Associate Director, Market Development, this free webinar will offer guidance on optimal approaches to help secure approval for future submissions in this changing and challenging regulatory environment.
Aimed at professionals working in drug development, packaging, business development, CMC and regulatory affairs, the informative webinar offers key learnings in:
- 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
Badre Hammond explained, “The FDA’s recent quality consideration for Combination Products which was released earlier this year, is the latest effort by regulators to clarify a very complex topic. Having supported over 100 successful NDAs and ANDAs in the past five years, we will share practical insights from Aptar Pharma’s past experiences in navigating regulators’ expectations in the context of development of Combination Products.”