CMC and Regulatory Requirements for Inhalation Drug Products

    8 -10 May 2023, live online training

    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

    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 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainers

    Dr. Manfred Fischer is a Biophysical Chemist. He has more than 30-year experience in the pharmaceutical industry, mainly in the CMC arena covering analytical / formulation development of new and generic products and Quality Control of medicinal products.

    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.

    ONLINE PARTICIPATION
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 056 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate
    .

    Price per delegate including:

    Online participation

    Recorded sessions for 30 days

    Online workbook & materials

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      8. May 2023
      01:00 PM Vienna time
      12:00 PM London time
      07:00 AM New York time
      04:00 AM Los Angeles time
    • End Date
      10. May 2023