CMC-and-regulatory-requirements-for-inhalation-drug-products
CMC-and-regulatory-requirements-for-inhalation-drug-products

Course Description

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.
  • Regulatory guidance
  • Physical characterization of starting materials
  • Control of Extractables/ Leachables
  • Particle specification
  • Analytical method development and validation
  • Generic development of inhalation products
  • 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)

CMC and Regulatory Requirements for Inhalation Drug Products

18 - 20 June 2024, Live Online Training
€1.850,00
Dr. Manfred Fischer

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.

START TIMES

1:00 PM Vienna time

12:00 PM London time

7:00 AM New York time

4:00 AM Los Angeles time

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Course Description

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.
  • Regulatory guidance
  • Physical characterization of starting materials
  • Control of Extractables/ Leachables
  • Particle specification
  • Analytical method development and validation
  • Generic development of inhalation products
  • 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)

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

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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