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Medical writingProfessional or ₹3,200

Medical Writing for Regulatory Submissions

Regulatory writing taught by writing: ICH E3 structure, how to work from statistical output, and how to survive two rounds of sponsor review. You finish with two documents you can attach to an application.

8 hours12 lessonsComfortable writing in EnglishCertificate on completion
₹3,200one payment

Included in Professional at ₹499 a month, which works out cheaper at two courses or more.

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What it moves on your score
SkillsSpecialty relevanceCareer-transition feasibility
What you can do afterwards
Structure a clinical study report against ICH E3
Turn a statistical output table into readable prose
Handle sponsor review without losing the argument
Leave with two sample documents for your portfolio
Curriculum4 modules · 12 lessons
What a regulator reads
1The documents, and who reads each oneVideo13:00
2ICH E3 structure, section by sectionVideo21:00
3Reference sheet: ICH E3 skeletonNotes
Working from data
4Reading statistical output tablesVideo19:00
5Writing results without interpreting themVideo16:00
6Reference sheet: results-section phrasingNotes
The craft
7Sentence length, hedging and the passive voiceVideo15:00
8Consistency: the thing reviewers actually catchVideo12:00
9Writing assessment: a results sectionAssessment45:00
Review
10Two rounds of sponsor comment, and how to answer themVideo18:00
11Building a portfolio from anonymised workVideo14:00
12Portfolio assessment: two documentsAssessment60:00
The first two lessons of every course are open. The rest need Professional.
Taught by
Dr. Kavya Reddy
Principal writer, Prakash Medical Communications

Edits the writing samples of roughly forty applicants a year.

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