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Advanced Regulatory Writing Course

Master advanced regulatory writing for pharma/biotech. Learn to create clear, compliant documents (CSRs, CTDs, IBs) adhering to FDA, EMA, and international regulations. Develop skills in data interpretation, argument construction, and regulatory compliance through practical exercises. Ideal for medical writers, clinical research, and regulatory affairs professionals.

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English

Hours

Course description

This intensive course provides comprehensive training in advanced regulatory writing for the pharmaceutical and biotechnology industries. Participants will acquire the skills necessary to produce clear, concise, and persuasive documents, including Clinical Study Reports (CSRs), Common Technical Documents (CTDs), and Investigator Brochures (IBs), while adhering to the regulations set forth by the FDA, EMA, and other international bodies. Through practical exercises, participants will develop proficiency in data interpretation, argument construction, and regulatory compliance. This course is ideally suited for medical writers, clinical research professionals, and regulatory affairs specialists who seek to enhance their expertise and advance their careers.

What will i learn?

Requirements

Frequently asked question

This course is designed to equip you with the skills needed to create intricate regulatory documents for the pharmaceutical and medical device sectors.

This course is ideal for seasoned regulatory writers, scientists, and professionals aiming to elevate their expertise in the field.

Participants are expected to possess a strong grasp of fundamental regulatory writing principles and practical experience.

The course delves into advanced subjects, including the development of clinical study reports (CSRs), protocols, and Module 2 summaries for CTDs.

This program provides an in-depth exploration of the strategic aspects, data interpretation, and advanced document management crucial for successful complex submissions.

Absolutely. The course incorporates workshops, case studies, and hands-on writing exercises to foster practical skills.

Upon completion, you will confidently be able to write, edit, and review a diverse range of high-level regulatory documents.

This course prepares you for senior regulatory writing positions and significantly enhances your professional credibility.

Aushi Rai

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₹0

Lectures

7

Skill level

Beginner

Expiry period

Lifetime
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Friquently asked questions(FAQs)

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Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.

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Cohort Starts: 12th Jul 2025

10 Modules | Duration: 60 Hours
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