CMC and Regulatory Requirements for Inhalation Drug Products
24 – 26 February 2026
1 850 €
TRAINING TIMES
13:00 - 17:30 Vienna
12:00 - 16:30 London
07:00 - 11:30 New York
04:00 - 08:30 Los Angeles
WHY SHOULD YOU ATTEND?
Understand Regulatory Expectations for Inhalation Products
Gain clarity on key guidelines and pharmacopoeia requirements shaping the development of pMDIs, DPIs, and nebulizers
Master Analytical Methods and Validation
Learn how to apply and validate critical methods such as DDU and APSD, alongside other specialized techniques for inhalation drug testing
Strengthen Product Characterization Strategies
Explore best practices for characterizing APIs, excipients, and finished products, ensuring robust control strategies and compliance.
Navigate Generic Inhalation Drug Development
Get practical insight into regulatory requirements and development pathways for generic inhalation drugs, including pMDIs and DPIs.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Grasp the Fundamentals of Inhalation Drug Products
Understand the main characteristics of pMDIs, DPIs, and nebulizers and how they impact development
Apply Regulatory Guidance Effectively
Gain an overview of key guidelines and pharmacopoeia chapters relevant to inhalation drug development and compliance
Develop and Validate Robust Analytical Methods
Learn how to design, validate, and apply critical methods such as DDU and APSD, as well as other specialized analytical techniques
Strengthen Characterization and Control Strategies
Understand requirements for product characterization studies and build effective control strategies for APIs, excipients, and finished products
Advance Generic Inhalation Drug Development
Explore the specific regulatory and development considerations for creating generic pMDIs and DPIs
WHO IS THIS TRAINING FOR?
Regulatory Affairs
CMC
Analytical Development
Quality
Research & Development
Formulation & Process Development
KEY TOPICS
Regulatory guidance
Physical characterization of starting materials
Control of Extractables/ Leachables
Particle specification
Analytical method development and validation
Generic development of inhalation products
TRAINER
PAST PARTICIPANTS
Medical Device Risk Management: Understand and Interpret Key Regulations and Standards
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
