Decoding the FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays.
Sponsored by: Aptar Pharma
- Combination Drug Product Guidance
Date: 18 September
Days to go: 32
Time: 3PM London/10AM New York
In April 2018, the FDA released guidance for quality consideration for pMDI and DPI affecting the inhalation approach to ANDA/NDA applications. This comes on the back of 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.
This webinar, hosted by Aptar Pharma, will provide guidance on how the 2018 guidance affects future submissions and summarize an overview on Combination Products FDA guidance focusing on respiratory and nasal drug products, specifically DPIs, pMDIs, and Nasal Sprays. With over 25 years’ experience supporting our customers’ regulatory submission and 100 successful NDAs and ANDAs, Aptar Pharma will share insights on optimal approaches to help secure approval in this changing and challenging regulatory landscape.
Outcome for Participants: Attendees will gain practical insights to navigate FDA expectations for device information in NDA and ANDA submissions for combination products in the context of the current guidance.
Badre E. Hammond, MBA,
Assoc. Director Business development
Badre Hammond’s background is in Biochemistry and drug development with 14 years’ experience in pharmaceutical product development with a focus on nasal and pulmonary drug delivery systems. Mr. Hammond has broad experience in managing development of novel drug product programs for the pharmaceutical market from formulation development, pre-clinical, CMC, to clinical phase. In his current role, he leads business development activities for Aptar Pharma focusing on the North America region.
Regulatory Affairs Manager
Wendy Bolf’s expertise is in Regulator Affairs with a BASc in Chemical Engineering and she has specialized in drug delivery systems for 20+ years. Mrs. Bolf has headed up the regulatory affairs department and has developed strategies for Aptar’s Drug Master Files and directly supported numerous FDA inspections on site as well as Type C meetings with FDA in order to gain approval of strategies including CMC sections, approval of INDs, NDAs, and ANDAs – mostly specializing in nasal and pulmonary drug delivery. Mrs. Bolf has been involved from the device regulatory side in supporting the approval of dozens of drug products (NDA and ANDAs) on the US market. In her current role, she is involved in Combination Product regulatory strategies for Aptar Pharma.
Key Learning Objectives
- 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 product
- Clarify expectations: Sponsor, device supplier and regulators
- Research & Development
- Academic Researchers
- Laboratory Testing
- Sales & Marketing
- Business Development
- Project Managers
- Product Managers
- Category Managers
- Regulatory Managers