Webinars, Pharmaceutical
Aptar Pharma Provides Guidance on FDA Regulatory Framework for OINDPs
18 Sep 2018
In April 2018, the FDA released guidance on metered dose inhaler and dry powder inhaler product - quality considerations, hot on the heels of finalized FDA guidance for combination products issued in January 2017, where a combination product is defined as one composed of two or more different types of medical products. This webinar provides practical insights into how to navigate FDA expectations relating to NDA and ANDA submissions, in the context of the current guidance, in the development of Orally Inhaled and Nasal Drug Products (OINDPs). Insights on optimal approaches to help secure approval in this changing and challenging regulatory landscape are shared.
September 18, 2018
5:00 PM London / 12:00 PM New York
1 Hour
September 18 - September 18 2018 1:00 PM London / 8:00 AM New York
Presenter(s): Badre Hammond Wendy Bolf
18 Sep 2018
Presented By
Badre Hammond
VP Commercial Operations, Aptar CSP
Badre Hammond’s background is in Biochemistry with 14 years’ experience in pharmaceutical product development with 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.
Wendy Bolf
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.
