CMC and Regulatory Requirements for Inhalation Drug Products

    12 – 14 December 2023, live online training


    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


    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.

    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 1 997 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 7 days

    Online workbook & materials


    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
    +421 222 200 543

    Training Details
    • Start Date
      12. December 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
      14. December 2023
    What participants said about Symmetric courses

    "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot."
    Senior Development Pharmacist, Orion Corporation

    "Keep up the excellent standard of training courses!"
    FDF Industrialisation Manager, Medichem Manufacturing

    "I have received a lot of knowledge that will be of big use for my profession."
    Quality manager, Vironova AB

    "Thank you for a very informative training course. The timing of start/break/finish was perfect."
    Clinical Project Manager, Regen Lab

    "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks."
    Head of API and Contract Manufacturing, Zentiva Group

    "Very informative and memorable training course for me."
    Quality Vice President, Darou Pakhsh

    "The trainer was very knowledgeable about the topics and was able to answer all questions."
    Drug Product Subject Matter Expert, Pfizer