Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in a dossier to support clinical studies and marketing applications. This information must be updated as more information is gained throughout a drug’s lifecycle. The required content and format of the CMC section for various applications are described in guidance documents provided by the International Council on Harmonization (ICH) and individual regions where the product is intended to be marketed.

This course provides an overview of the CMC section of dossiers. It discusses the CMC information necessary to support original investigational applications; identifies CMC changes that require investigational application amendments; and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC-specific guidances.

The CMC section is synonymous with the quality section in some application formats, such as the electronic Common Technical Document (eCTD). For ease of review, this discussion is generically described as the CMC section.

This course is equivalent to 39 hours of learning and covers the following:

1.Scope of the NHP Regulation
2.Product classification
3.Product Licensing
4.Site Licensing
6.Labeling and Packaging
7.Importation for sale in Canada
9.Clinical Trials
10.Adverse Event Reporting

Course outline:

  1. Laws and Regulations
  2. Quality System
  3. Software
  4. Combination and IVD Devices
  5. 510 Premarket Notification
  6. Device Modification
  7. PMA
  8. Clinical IDE and HDE
  9. Compliance with FDA
  10. Imports and Exports
  11. Working with FDA

Preparation of modules 1 to 5 of the eCTD for drug submission.

This certificate covers the following outlines:

1- Healthcare product types
2- Stages of healthcare product life cycle
3- Common responsibilities of RA professionals
4- Regulatory agencies in major regulatory systems and timelines for drug registrations
5- Introduction to eCTD
6- Post approval activities and compliance

This program covers the following topics:

  1. Medical Devices Regulation and device classification (Canada)
  2. Establishment license, labelling requirements and Importation
  3. Mandatory reporting (Incident reporting for medical devices: Guidance Document)
  4. Foreign Risk Notification for Medical Devices Guidance Document
  5. Guidance on Summary Report and issue-related analysis for Medical Devices