RDD Asia 2018 will feature a half day of Interactive Workshops on Thursday, November 15, 2018.
Workshops provide an opportunity for companies to sponsor, in a technical rather than an overly-commercial manner, practical and interactive demonstrations of innovative technologies, products, capabilities and services.
Each workshop will last 60 minutes (including demonstration and questions) and should be designed for small groups of 10–40 delegates to encourage audience interaction. Each workshop will be repeated three times to ensure that delegates have the greatest opportunity to attend their preferred selections. Only a limited number of organizations will be selected to host a Workshop.
Workshop Descriptions and Selection
Workshop Descriptions
AIMIL
Assessing Bioequivalence for Nasal Sprays and Dry Powder Inhalers: Application of Physicochemical Test Methods
Two techniques which are referenced by the FDA in their bioequivalence guidance documents will be covered using case studies: Morphologically Directed Raman Spectroscopy (MDRS), used to obtain component-specific particle size and size distribution measurements for APIs present within OINDP formulations; and Laser Diffraction droplet sizing. Attendees will leave with a better understanding of how component-specific particle size data obtained using MDRS can then help with formulation elucidation, dispersion of the API both before, and after, device actuation, and how these parameters are related to demonstrating bioequivalence.
Amcor
Cooperation in the Qualification and Validation of Primary Packaging for Dry Powder Inhalers to Gain Generic Drug Registration
The goal of this workshop is to show the main differences in regulatory filing approaches (with a focus on generics) in different countries. Participants will look at key areas of aluminum primary packaging, including: material processing, prototyping & development, troubleshooting, extractables and leachables, quality systems and DMFs (drug master files) or other regulatory dossiers and how all these factors are key to successful regulatory approvals worldwide.
Aptar Pharma
Decoding FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays
This presentation will provide guidance concerning future submissions of combination products. It will review various topics, including: the definition of combination products, NDA/ANDA submissions, regulatory pathway review, Human Factor studies in the context of combination product, sponsor/device supplier/regulators expectations. Finally, it will review EMA’s strategy as they elevate their requirements. Attendees will gain practical insights to navigate FDA/EMA expectations for device information inNDA and ANDA submissions for combination products in this changing and challenging regulatory landscape.
H&T Presspart
Unit-dose Dry Powder Inhalers: Challenges and Opportunities to Meet Patient Needs
This workshop will focus on various aspects of Human Factors, including handling of powder formulations, device development, and targeting high fine particle fractions and drug delivery using cost effective DPI solutions. New opportunities with regard to materials, airflow designs and ergonomic features for patient handling will also be reviewed. The workshop aims to provide attendees with an overview of unit-dose DPI development pathways and how to successfully overcome the challenges involved in bringing these inhaler devices to the market.
MEGGLE
Get the Right Grade: An Inhaled Lactose Guide for Dry Powder Inhaler (DPI) Formulations
Using case studies, this workshop will explain how the particle size of the carrier significantly changes the delivered dose and fine particle fraction of DPIs. It will provide insight into the interplay between carrier lactose with the type of device to reveal what type of carrier is most suitable for which type of device. The case studies will also explore how lactose fines are often used in conjunction with carrier lactose (ternary powder formulations) to optimize DPI performance. By attending this session participants will gain a deeper understanding of what lactose carrier and fines can achieve in a DPI formulation.
Proveris
A Step-wise Guide to Orally Inhaled and Nasal Drug Product (OINDP) Development
This workshop will describe the development process of an OINDP candidate from designing early stage device/formulation screening to performing the range of in vitro characterization tests and submission to relevant regulatory authorities. Attendees will come up with real problems they might encounter during OINDP development and the instructors will provide feedback and discuss solutions. Troubleshooting approaches for common roadblocks encountered during development will also be covered. Participants will gain an understanding of a scientific and cost/time effective approach towards OINDPs from early development to regulatory submission.
