Dr. NIKITA SARASWAT

Dr. Nikita Saraswat is a University Gold Medalist with 14 years of academic and research experience.

Course available for 1 year after purchase

✅ Medical Writing & Clinical Documentation 📄✍️
Gain an understanding of the structure and purpose of key clinical documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), Protocols, and Informed Consent Forms (ICFs). Learn the principles of Patient Information Leaflets (PILs), Summary of Product Characteristics (SmPCs), and Risk Management Plans (RMPs) as per industry guidelines.

✅ Regulatory Writing & Submission Dossiers 📑📝
Get an overview of Common Technical Document (CTD) Modules, including essential elements of New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologics License Applications (BLA). Understand the basics of Investigational New Drug (IND) submissions, Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs), along with key considerations in responding to regulatory queries from FDA, EMA, MHRA, CDSCO, and other agencies.

✅ Scientific Writing & Publications 📚📊
Learn the foundational aspects of manuscript preparation, systematic reviews, and meta-analyses for scientific journals. Understand Good Publication Practices (GPP) and key referencing guidelines (ICMJE). Get introduced to conference abstract writing, white papers, and medical communications while exploring essential tools like EndNote and Mendeley.

✅ Medical Literature Evaluation & Data Interpretation 🔬📖
Familiarize yourself with PubMed/MEDLINE, Embase, and Cochrane databases for literature research. Understand how to extract and summarize clinical trial data and interpret statistical findings for medical writing applications. Learn about real-world evidence (RWE) studies and their relevance in regulatory submissions.

✅ Technical Writing Tools & Software 🖥️⚙️
Gain exposure to Microsoft Word templates for eCTD submissions, AI-assisted literature search tools, and referencing software like Zotero, EndNote, and RefWorks. Learn best practices for formatting and structuring regulatory and scientific documents in compliance with industry standards.

✅ Pharmacovigilance Writing & Drug Safety Reporting 💊🛡️
Understand the role of medical writers in Pharmacovigilance (PV) documentation, including Individual Case Safety Reports (ICSRs), Narrative Writing, and Periodic Benefit-Risk Evaluation Reports (PBRERs). Learn the basic requirements of EudraVigilance, MedDRA coding, and adverse event reporting.

✅ Industry Case Studies & Career Readiness 🎯🚀
Explore real-world examples of regulatory, medical, and scientific writing with insights into industry expectations in pharmaceutical companies, CROs, and regulatory agencies. Learn about essential job application strategies, resume building, LinkedIn optimization, and interview preparation for MNCs.

💡 This course provides a broad technical foundation to help you understand the core principles and expectations of the Medical, Regulatory, and Scientific Writing industry and secure a role in top MNCs & CROs! 🚀

Certified Professional Course in Medical, Regulatory, and Scientific Writing

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Medical, Regulatory & Scientific Writing Course Promo

Course Promo

Learn Medicine by Dr.Nikita

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    https://www.learnmedicinebydrnikita.in/courses/636764?utm_source=linkedin&utm_medium=social-link&utm_campaign=web-course-share

Hey! I’m learning with Learn Medicine by Dr.Nikita and you can too. Here’s a course you might like: Certified Professional Course in Medical, Regulatory, and Scientific Writing by Dr. NIKITA SARASWAT
    https://www.learnmedicinebydrnikita.in/courses/636764?utm_source=copy-link&utm_medium=social&utm_campaign=web-course-share

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