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About the Course
This 6-month diploma course provides in-depth training on key aspects of regulatory affairs and medical writing. It covers essential topics such as Drug Discovery and Development, Regulatory Intelligence, Clinical Trial Applications, and GxP Compliance to ensure proficiency in global regulatory standards.
Participants will gain hands-on experience in CMC (Chemistry, Manufacturing & Controls), Labelling & Artwork Management, Life Cycle Management, and Submission Publishing using the ICH Suite. Additionally, the course includes training on RIMS (Regulatory Information Management Systems), Supply & Product Management, and Scientific & Clinical Medical Writing to enhance documentation and compliance skills.
This program is ideal for professionals aspiring to excel in the pharmaceutical, biotechnology, and healthcare industries by mastering regulatory frameworks and medical documentation best practices..
Key Tools and Skills from this Course.
Drug Discovery and Development
Regulatory Intelligence
Clinical Trail Applications
Regulatory Writing
Clinical Regulatory Affairs
CMC
Labelling & Artwork Management
Scientific Writing
Life Cycle Management
Submission Publishing
ICH Suite
Clinical Medical Writing
RIMS
GxP
Supply Management
Product Management