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Study Modules of Online Certificate Courses in Drug Regulatory Affairs


Building a career in Drug Regulatory Affairs can be a great career opportunity. Opting for this certification course will help you come across a wide range of topics taught under the various modules offered by this program. Do you want to learn in detail about the various modules offered by this course? Well, let this blog help you out! Go through this blog to learn precisely about the various modules offered by this certification course.

The list of modules offered by Online Certificate Courses in Regulatory Affairs

Here's a list of modules offered by Online Certificate Courses:

Various stages in Drug development

This is a mandatory module offered by Online Certificate Courses in Drug Regulatory Affairs. Any newly manufactured drug product requires it to go through various stages before it is introduced for human use. The stages of drug development are characterized by discovery, categorization, preclinical testing, clinical trial, drug disposition, packaging, etc.

ICH guidelines

ICH stands for The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use. ICH functions to provide uniform standards for pharmaceutical products used for human needs. 'Quality, Safety, Efficacy, and Multidisciplinary' are the primary categories of ICH.

WHO guidelines

It is another significant part of the module which elevates the overall course. The prescribed guidelines of WHO state whether the drug products they develop are fit for clinical purposes or not. Besides, it also greatly focuses on the composition and formulation of pharmaceutical products. The packaging, storage, shelf-life, etc., are also included in the WHO guidelines.

Compliance guidelines

Compliance guidelines allow individuals to get detailed knowledge about approval for new drug products. This module offered by the Certificate Course in Regulatory Affairs also enables individuals to understand whether the launched pharmaceutical product will be retained in the pharmaceutical industry for long or not. Moreover, it focuses on the efficacy, safety, and quality of medicines.

Quality Assurance and Drug Regulations

Regular review and inspection of pharma industry manufacturing sites is made to ensure the safety and efficiency of the drug products. In this module, individuals will gain comprehensive knowledge of all aspects of the pharma industry that are responsible for impacting the quality of drug products.

Common Technical Document Filing

Filing of common technical documents is further divided into multiple modules, namely administrative information, technical document summaries, non-clinical study reports, clinical study reports, etc. It helps in the registration of medicines to be used across countries. More specifically, it is a set of specifications allowing better registration of drug products.

Industry-specific case studies

Going through industry-specific case studies will allow you to understand the latest trends and hot topics in the pharmaceutical industry. Since it comprises a wide range of topics and is always evolving, keeping track of the latest trends prevalent in regulatory affairs will keep you ahead. You can look for free online certificate courses in Drug Regulatory Affairs to get more details on industry-specific case studies.

Conclusion 

These were some of the most common modules offered by the Certificate Course in Drug Regulatory Affairs. Are you looking for the best training center to avail of this course? Reach out to Company Connect Consultancy to avail the best Certificate Course in Drug Regulatory Affairs.

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