📚 Syllabus & Course Curriculum
AI & Machine Learning in Healthcare
Module-by-module breakdown of Navigating Regulatory Affairs: Ensuring Compliance in Clinical Research, from foundations to a certified capstone project.
Outline
Overview of regulatory affairs and its importance in clinical research • Roles and responsibilities of regulatory affairs professionals
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Understanding global regulatory authorities and their roles • Familiarization with key regulatory guidelines and requirements
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Components and preparation of an IND application • Interaction with regulatory agencies for IND submission and review
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Structure and content of an IMPD • Submission and evaluation of IMPD for clinical trials in Europe
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Preparation of documents for ethics committee submissions • Review process and ethical considerations in clinical research
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Informed consent process and documentation • Ensuring subject safety and rights in clinical trials
Outline
Preparation and submission of CTA applications • Interaction with regulatory authorities for CTA approval
Earn government-registered certification in Navigating Regulatory Affairs: Ensuring Compliance in Clinical Research
e-Certificate and e-Marksheet issued on successful completion.
