As part of the Platinum Sponsor Seminars at RDD 2018, Aptar Pharma experts will present a 40-minute talk on the most recent FDA guidance on Combination Products, with a focus on respiratory and nasal drug products
Aptar Pharma, a leading global solution provider of innovative drug delivery systems, will be the Platinum Sponsor at RDD 2018, taking place from April 22 to April 26 at the JW Marriott Starr Pass Resort and Spa, Tucson, Arizona.
The RDD conference series is recognised as one of the premier international meetings in the respiratory field, impacting regulatory and scientific policies worldwide.
As part of the Platinum Sponsor Seminars at RDD 2018, Aptar Pharma experts will present a 40-minute talk on the most recent FDA guidance on Combination Products, with a focus on respiratory and nasal drug products. The seminar, entitled ‘Decoding FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays’ will be presented by Badre Hammond, Associate Director, Market Development Aptar Pharma Prescription and Wendy Bolf, Regulatory Affairs Manager, Aptar Pharma Prescription.
The seminar will give insights on optimal approaches to help secure approval in this changing and challenging regulatory landscape and will specifically address the following topics:
- 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
Aptar Pharma’s Platinum Sponsor Seminar will take place twice on Tuesday, April 24 in Tucson Room I and J, at 8:00 AM and again 8:45 AM, ensuring delegates have the greatest opportunity to attend their preferred time slot.
In addition to presenting at RDD 2018, Aptar Pharma will be hosting an interactive table, located in the Arizona Ballroom, where their team of experts will showcase their innovative range of MDIs, DPIs and BAIs, and demonstrate how they can accelerate speed-to-market by assisting customers from concept through to regulatory submission and approval.
The Aptar Pharma table will also feature a Connectivity Focus, dedicated to the growing field of c-Devices, offering insight into their range of add-on and integrated c-Devices. These intuitive devices feature fully-connected functionality and software integration to improve patient health outcomes.