Post Graduate Program in Medical Writing

About This Course

Post Graduate Program in Medical Writing

The  Post Graduate Program in Medical Writing by Kodakco will enhance your skills as a Medical Writer as it will equip you with a core understanding of the methodologies of Medical Writing

5 in 1 Course

• Training
• Projects
• Placement Support
• Certification
• Assignments

Industry Projects

Get hands-on experience in relevant industry projects with the Post Graduate Program in Medical Writing.

Takeaways of Your Investment

• Acquire knowledge about the categories of Medical Writing and its scope
• Be aware of the ethics in Scientific Communication
• Write Scientific Research Papers for Journals
• Learn about the Drug Development Process and Clinical Study Designs
• Know the International Conference on Harmonisation (ICH) Guidelines
• Differentiate between Clinical and Non-Clinical Writing
• Prepare the Dossier in CTD format or eCTD submission
• Effectively communicate the Medical details to a Non-Medical audience

Module 1: Medical Writing

Strengthen your writing prowess as you boost your skills as a medical and scientific writer

• Learn the essential ethics for Medical Communicators and elements of medical terminology
• Provides insights about the scope, requirements, and applications of Medical Writing
• Learn various models and techniques and master Medical writing
• Learn skills for data extraction, evaluation, and interpretation; writing of well- structured scientific documents
• Understanding the skills required to be a Medical Writer for different types of target audiences
• Acquire extensive knowledge about the Drug Development Process
• Learn about Medical Writing for Clinical Trial
• Create Development Safety Update Reports and Amend Reports
• Guidelines to Publish Clinical Data
• Pre-clinical/Non-Clinical Writing
• Medical Writing for Clinical Trial
• Drug Development Process
• Scientific Writing
• Medical Writing In Post-Marketing Studies /Development
• Introduction to Medical Writing
• Be Aware of the guidelines for publishing Clinical Data
• Gain Extensive knowledge about the Pre-clinical and Non-Clinical Writing

Module 2: Pharmacovigilance

Pharmacovigilance is required through the entire life cycle of a drug at the preclinical development stage and going right through continued monitoring of drugs.

• Importance of scientific background, develop a solution plan and impart guidance on Pharmacovigilance Training Course.
• Design & cost-efficient and scalable system using techniques.
• Acquire knowledge about medicines and many more.
• Effectively communicate the Medical details to a Non-Medical audience
• Learn about the essential Ethics for Medical Communicators
• Usage of herbal remedies that may pose toxicological problems when utilized alone or in combination with other medicines.
• Roles in this specialism focus on the analysis of drug safety information gathered from other professionals.
• Drugs in clinical research and periodic benefit-risk evaluation report (PBRER) for drugs that are on the market
• Introduction of Pharmacovigilance
• Medical Evaluation Of Adverse Events In Pharmacovigilance
• Case Processing
• Pharmacovigilance Reporting Database, Signal Detection, Management, and Risk Assessments & Evaluation
• Medical Dictionary For Regulatory Activities MedDRA
• PV laws And Guidelines

Module 3: Content Writing

Develop writing skills for Creative Writing, Business Writing, Technical Writing, Medical Writing, Social Media Writing, SEO Writing, Book Writing, Copywriting, and much more. Transform yourself into a Content Strategist and earn online with projects from the US & UK.

• Learn Basic Writing and language skills
• Get in-depth knowledge of the Basic Internet Skills
• Learn the fundamentals of various types of writing such as Technical, Medical, and more.
• Acquire the Skills of Various Content Strategies
• Get exposed to International Projects with high Remunerations
• To earn online from International Projects.

Module 4: Advanced Excel

This course will guide the learner with every function of Advanced Excel such as Lookup Functions, Pivot Table, Power Query, What-if Analysis, VBA, and other essential functions required for a Medical Writer

• Acquire the basic knowledge of MS Excel and Its working
• Learn to use MS Excel for Medical Writing
• Understand all the advanced Excel Functions
• Gain knowledge about the Lookup Functions for Medical Writing
• Be aware of Pivot Table and other essential functions of Excel
• Get acquainted with the basics of VBA and What-if Analysis
• Know about Power Query and User-Defined Functions
• Learn about the Advanced Excel Functions, Advanced VBA, and more

Module 5: Regulatory Writing

Learn about developing preclinical and clinical research procedures into documents and submission packets that review and record essential study conduct, practices, and results. 

• Introduction to the Drug & Cosmetic Act
• Schedule Y
• Indian Regulations Governing Clinical Trials
• Common Technical Document
• Regulatory Regime in the US
• European Medicine Agency (EMEA)
• Overview of Regulatory, Marketing & Drug Promotion Process
• ICH Guidelines
• IND & NDA Requirements
• Clinical Study Reports
• Protocol, Investigators Brochure & Case Report Forms

Module 6: Simulated Medical Writing Projects

• Medical Research and Essay Writing
• Writing a Scientific Story
• Writing Clinical Research Report
• Creating Medical Brochures
• Creating Promotional Material