Navigating the Transition to Low Global Warming Potential Propellants

Schedule

Wed Dec 04 2024 at 08:30 am to Thu Dec 05 2024 at 05:30 pm

UTC-05:00

Location

The Universities at Shady Grove | Rockville, MD

Join the FDA and Center for Research on Complex Generics (CRCG) for a hybrid public workshop on Dec 4-5, 2024.
About this Event

Full event title: Navigating the Transition to Low Global Warming Potential Propellants

Registration Fees:

  • $500, in-person attendees - general
  • $150, in-person attendees - government (must have an email ending in ".gov" in order to register at this rate)
  • Free, virtual attendees
  • For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at ([email protected]) and indicate which workshop you are interested in.


Current hydrofluoroalkane (HFA)-based propellants, like HFA-134a and HFA-227, play several roles for metered dose inhalers (MDIs), such as serving as the primary driving force for dose aerosolization and drug delivery. However, concerns around their contribution to climate change have driven global efforts to transition to newer low global warming potential (LGWP) propellants for use in MDIs and other commercial products. While the previous chlorofluorocarbon (CFC) to HFA-based propellant transition provides a historical reference for navigating such a transition, the current LGWP propellant transition presents potential scientific and regulatory challenges for both brand name and generic MDIs that require consideration.

The purpose of this two-day workshop is to engage subject matter experts from academia, brand name and generic drug industries, and health and regulatory agencies to discuss the current scientific understanding of LGWP propellants and the challenges encountered by the drug industry as they advance their transition development programs. This workshop will also cover the scientific and regulatory considerations regarding the data requirements to support an MDI transition program for both brand name and generic drugs. In-person attendees at the workshop will also be able to participate in small group working sessions on regulatory considerations and development strategy.

During Day 1, the workshop focus will be on the considerations around developing a brand name MDI utilizing a LGWP propellant. Presentations will cover what was learned during the previous propellant transition, what is currently understood about LGWP propellants and their impacts on product performance, and the scientific and regulatory considerations regarding a brand name LGWP propellant MDI development program. These talks will be followed by presentations from the industry’s perspective, as brand name companies discuss their experiences and current challenges with developing LGWP propellant MDIs. At the end of Day 1, in-person attendees will be able to participate in small group working sessions, collaborating with scientific experts and health regulators regarding different scenarios an applicant may encounter during LGWP propellant product development and submission, and engaging in dialogue to consider practical approaches that can address the scientific and regulatory challenges of this transition as efficiently as possible. The presentations on Day 2 will focus on developing a generic LGWP propellant MDI from both a regulatory agency and industry perspective. Presentations will cover the scientific and regulatory considerations for generic LGWP propellant development programs along with industry’s experience and challenges. The second part of Day 2 will then examine the propellant transition from a global perspective, with presentations to understand how similarities and differences between regulatory agencies may affect the transition process for drug developers. Day 2 will end with a panel discussion covering the critical points learned from the Day 1 and 2 presentations and discussions.

Through this workshop, attendees will obtain a better understanding for the basis of the current regulatory thinking regarding LGWP propellant transition programs, along with instances where challenges may still be present that could influence a drug developer’s LGWP propellant MDI development and marketing strategy.

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person) working sessions. Virtual attendees will be able to:

  • Attend all presentations and panel discussions
  • Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
  • Enjoy free access to workshop recordings of presentations and panel discussion (not including the working sessions)

In-Person Attendees will enjoy all the benefits of virtual attendees, and will also have an opportunity to engage in dynamic, small group working sessions to discuss the scientific and regulatory challenges associated with transitioning to LGWP propellants for MDI. In-person attendees will be able to:

  • Collaborate in person with FDA, industry, and academic experts throughout the workshop, and particularly during small group working sessions
  • Engage in dialogue with attendees and faculty
  • Converse with panelists during discussion panel Q&As
  • Network with colleagues and other industry professionals during breaks

Workshop Topics

  • Scientific understanding of LGWP propellants
  • Scientific and regulatory considerations for brand name and generic MDIs
  • Development strategies for LGWP propellant MDIs
  • Global perspectives on propellant transition

This workshop is primarily designed for professionals involved in the development, regulation, and use of metered dose inhalers (MDIs) including regulatory representatives, pharmaceutical industry professionals, academia and research institutions, and healthcare professionals.

Virtual Attendance is optimal for an audience that is interested in an introduction to the current scientific understanding of LGWP propellants and the challenges encountered by the drug industry as they advance their transition development programs.

In-Person Attendance is optimal for an audience that is invested in collaborative discussions with the FDA, industry colleagues, and representatives from generic and brand name drug industries to develop best practices to address scientific and regulatory challenges.

Where is it happening?

The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, United States
Tickets

USD 0.00 to USD 500.00

Center for Research on Complex Generics

Host or Publisher Center for Research on Complex Generics

It's more fun with friends. Share with friends

Discover More Events in Rockville

The Last Election
Fri Dec 06 2024 at 06:30 pm The Last Election

Bender JCC of Greater Washington

Breakfast with Santa
Sat Dec 07 2024 at 08:00 am Breakfast with Santa

Bethesda North Marriott Hotel & Conference Center

BREAKFAST-WITH-SANTA
2nd Annual Rushers Are Us Showcase
Sat Dec 07 2024 at 08:00 am 2nd Annual Rushers Are Us Showcase

60 Southlawn Ct

SPORTS FOOTBALL
Breakfast with Santa
Sat Dec 07 2024 at 08:00 am Breakfast with Santa

5701 Marinelli Rd

BREAKFAST-WITH-SANTA PICTURES-WITH-SANTA
Discover the Power of Systema: Free Self-Defense Trial Class for Adults
Tue Jun 08 2021 at 06:00 pm Discover the Power of Systema: Free Self-Defense Trial Class for Adults

Woodley Gardens Park

WORKSHOPS ART
Business Opportunity in DC, MD, VA area
Sat Nov 04 2023 at 09:30 am Business Opportunity in DC, MD, VA area

Rockville

BUSINESS WORKSHOPS
Rockville Maryland First Time Homebuyer Seminar (Online Event)
Fri Jul 19 2024 at 07:00 pm Rockville Maryland First Time Homebuyer Seminar (Online Event)

Rockville

WORKSHOPS VIRTUAL
VXN with Nasha
Tue Jul 23 2024 at 07:00 pm VXN with Nasha

9737 Traville Gateway Dr

WORKSHOPS HEALTH-WELLNESS
Real Estate Class TRIVIA
Tue Aug 13 2024 at 08:00 pm Real Estate Class TRIVIA

Rockville

WORKSHOPS
Fall Wealth Renewal in Rockville: Velocity Banking Workshop!
Thu Sep 05 2024 at 08:00 pm Fall Wealth Renewal in Rockville: Velocity Banking Workshop!

Rockville

WORKSHOPS
CEO Seminar Series: Leadership & Strategy
Tue Oct 08 2024 at 08:00 am CEO Seminar Series: Leadership & Strategy

Norbeck Country Club

WORKSHOPS BUSINESS
Create from Nature
Tue Oct 22 2024 at 12:30 pm Create from Nature

Rockville

ART FINE-ARTS
Breathwork - Free Weekly Class \u2022 Rockville
Wed Oct 23 2024 at 01:00 pm Breathwork - Free Weekly Class • Rockville

Soul Dimension

HEALTH-WELLNESS WORKSHOPS
Hands-On Event On Basic Implant Course
Fri Oct 25 2024 at 07:30 am Hands-On Event On Basic Implant Course

Liberty Construction - Dental & Medical Fit Outs

WORKSHOPS
School's Out Day Camp at Hammer & Stain Rockville!
Mon Nov 04 2024 at 09:00 am School's Out Day Camp at Hammer & Stain Rockville!

Hammer & Stain Rockville, Gibbs Street, Rockville, MD, USA

KIDS SPORTS
School's Out Day Camp at Hammer & Stain Rockville!
Tue Nov 05 2024 at 09:00 am School's Out Day Camp at Hammer & Stain Rockville!

Hammer & Stain Rockville, Gibbs Street, Rockville, MD, USA

KIDS SPORTS
Successful Open Houses CE
Tue Nov 05 2024 at 09:30 am Successful Open Houses CE

6100 Executive Boulevard, Rockville, MD, USA

BUSINESS WORKSHOPS
Updates:Acceptable Intakes of NDSRIs & BE Assessment for Reformulated Drugs
Wed Nov 06 2024 at 08:30 am Updates:Acceptable Intakes of NDSRIs & BE Assessment for Reformulated Drugs

The Universities at Shady Grove

WORKSHOPS BUSINESS
Virtual Seller Workshop
Thu Nov 07 2024 at 11:00 am Virtual Seller Workshop

Keller Williams Rockville, MD 12:45 Team

WORKSHOPS
Home Buyer Seminar- Virtual
Thu Nov 07 2024 at 12:30 pm Home Buyer Seminar- Virtual

12:45 Team, Keller Williams, Rockville

WORKSHOPS

What's Happening Next in Rockville?

Discover Rockville Events