Summary
The objective of this course is to provide delegates with a sound understanding of the regulatory and CMC aspects of inhalation products. You will receive a comprehensive update on the regulatory framework (EMA & FDA) and a thorough understanding of the CMC requirements for inhalation drug products.
Learning Objectives
- Main aspects / characteristics of inhalation drug products (pMDI, DPI and Nebulizer)
- Overview of the key regulatory guidance documents (guidelines and pharmacopoeia general chapter)
- Dive into the specific methods for APIs and excipients used for inhalation drugs
- Detailed discussion of the key analytical methods for inhalation drug products (DDU and APSD, incl. validation and control strategy)
- Overview of the other specific analytical methods used for inhalation drug products
- Requirements for drug product characterization studies
- Key aspects of development for generic inhalation drugs (pMDI and DPI, incl. regulatory requirements)
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
Who should attend?
This course is suitable for all those involved in:
- Regulatory Affairs
- CMC
- Quality
- Formulation & Process Development
- Analytical Development
Past participants
- Senior Principal Scientist, Lonza
- CMC Regulatory Affairs Manager, AstraZeneca
- Analytical Specialist, Polpharma
- Regulatory Affairs Manager, Vectura
- Manager CMC, Stada Arzneimittel
- Senior Analytical Scientist, Chiesi
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
CMC and Regulatory Requirements for Inhalation Drug Products
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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