InstructorRoyed Training
TypeOnline Course
Price$490/ 27500 INR.
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medical writing course

Introduction

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Who should attend

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About Medical Writing

The Medical Writing Course by Royed Training is designed to equip participants with the essential skills and knowledge required to excel in the field of medical writing. This comprehensive course covers various aspects of medical writing, including regulatory documentation, clinical trial reporting, and scientific publication. The medical writing course curriculum is tailored for individuals seeking to enhance their expertise in medical communication, whether they are beginners or experienced professionals looking to refine their skills.

Key details about the course:

  • Course Code: RYD-120
  • Title: Advanced Certification in Medical Writing (ACMW)
  • Type of the course: Medical Writing Training course is Self paced Online Course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
  • Duration of the course: 1 Month. Course can completed within 1 month based on own speed of access.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course
  • Eligibility : Graduation in any discipline.

Case Based Learning

  • Advanced medical writing training on strategic writing standards.
  • Medical Writing Course covers essential medical affairs, medical writing skill areas in a single comprehensive training.
  • Access to Case Studies to learn about the drug commercialization steps. Hence, participants will develop advanced competency on medical writing.

Medical Writing training course

Benefits of Medical Writing Course

Career Advancement:

  • Enhance your resume with a certification that showcases your specialized skills in medical writing.
  • Open doors to new career opportunities in pharmaceuticals, biotech companies, clinical research organizations, and medical communication agencies.

Skill Development:

  • Royed’s Medical Writing course will help to gain practical skills in writing various types of medical documents and reports.
  • Improve your ability to communicate complex medical information clearly and accurately.

Professional Growth:

  • Stay updated with the latest trends and best practices in medical writing.
  • Build a network with professionals in the field through course interactions and forums.

Efficiency and Productivity:

  • Medical writing course will help to learn techniques to streamline the writing process, ensuring timely and efficient delivery of high-quality documents.
  • Reduce the likelihood of errors and omissions in your writing through a solid understanding of regulatory requirements and standards.

Confidence and Competence:

  • Gain confidence in your writing abilities through structured training and constructive feedback.
  • Achieve a level of competence that sets you apart in the competitive field of medical writing.

This online medical writing course is ideal for a wide range of professionals and individuals looking to advance their careers in medical writing or related fields. Specifically, it is designed for:

Aspiring Medical Writers:

  • Individuals seeking to enter the field of medical writing.
  • Recent graduates with degrees in life sciences, pharmacy, medicine, or related fields.

Healthcare Professionals:

  • Doctors, and other healthcare professionals looking to transition into medical writing.
  • Clinicians who wish to contribute to medical literature and clinical research documentation.

Pharmaceutical and Biotech Professionals:

  • Employees in the pharmaceutical and biotechnology industries who are involved in the creation of clinical documents.
  • Regulatory affairs professionals who need to understand the intricacies of medical writing for regulatory submissions.

Clinical Research Professionals:

  • Clinical research associates and clinical trial managers responsible for preparing clinical study reports and other documentation.
  • Those working in clinical research organizations (CROs) who need to enhance their writing skills for clinical documentation.

Scientific Researchers:

  • Researchers and scientists involved in drafting manuscripts for publication in medical journals.
  • Academics looking to improve their ability to write grant proposals, research papers, and review articles.

Medical Communication Professionals:

  • Medical communications and medical affairs specialists who produce medical education materials, marketing documents, and scientific communications.
  • Medical writers in agencies providing services to pharmaceutical and healthcare companies.

Regulatory Professionals:

  • Individuals working in regulatory roles who need to prepare and review regulatory submissions, including NDAs, INDs, and CTDs.
  • Those who want to ensure compliance with global regulatory requirements through precise and accurate documentation.

Freelance Writers:

  • Freelancers and consultants looking to expand their service offerings to include medical writing.
  • Independent medical writers seeking formal certification to validate their skills and attract more clients.

What is Medical Writing?

Medical writing is a specialized field that involves creating well-structured, clear, and scientifically accurate documents related to healthcare, medicine, and the pharmaceutical industry. These documents are intended for a variety of audiences, including regulatory authorities, healthcare professionals, researchers, and the general public. Medical writing plays a crucial role in the communication of scientific information and ensures that complex medical data is accessible and understandable.

Medical writing is the practice of producing well-organized, scientifically accurate, and clearly written documents related to medicine, healthcare, and the pharmaceutical industry. These documents can serve a variety of purposes, including regulatory submissions, clinical trial documentation, scientific publication, medical education, and health communication. Medical writing aims to convey complex medical information in a manner that is accessible and understandable to its intended audience, which may include regulatory authorities, healthcare professionals, researchers, and the general

Key Aspects of Medical Writing:

Types of Medical Writing:

  • Regulatory Writing: Involves preparing documents required by regulatory bodies such as the FDA, EMA, or other health authorities. Examples include clinical study reports (CSRs), investigator brochures, and new drug applications (NDAs).
  • Clinical Writing: Focuses on writing documents related to clinical trials and research, such as protocols, informed consent forms, and case study reports.
  • Scientific Writing: Includes writing manuscripts for publication in medical and scientific journals, review articles, and conference abstracts.
  • Medical Communications: Encompasses creating educational materials, patient information leaflets, and promotional content for pharmaceutical products.
  • Health Journalism: Writing articles for newspapers, magazines, and online platforms that explain medical topics to the general public.

Skills Required:

  • Scientific Knowledge: A deep understanding of medical and scientific concepts is essential for accurate and credible writing.
  • Research Skills: The ability to conduct thorough literature searches and interpret scientific data.
  • Attention to Detail: Precision in data presentation and adherence to regulatory guidelines are crucial.
  • Writing Skills: Proficiency in grammar, style, and clarity to effectively communicate complex information.
  • Critical Thinking: Analyzing and synthesizing information to present logical and coherent arguments.

Purpose and Importance:

  • Regulatory Compliance: Ensures that all necessary information is provided to regulatory authorities for the approval of drugs, devices, and treatments.
  • Education and Communication: Helps healthcare professionals stay informed about the latest research, treatments, and best practices.
  • Patient Safety and Awareness: Provides patients with understandable and accurate information about their health and treatments.
  • Scientific Contribution: Advances scientific knowledge through the dissemination of research findings and clinical trial results.

Ethical Considerations:

  • Transparency: Honest and transparent reporting of data and findings.
  • Confidentiality: Protecting patient privacy and confidential information.
  • Plagiarism: Ensuring originality and proper citation of sources.

Medical writing is a vital component in the medical and pharmaceutical industries, bridging the gap between complex scientific information and its practical application in healthcare. Through clear and precise documentation, medical writers contribute significantly to the advancement of medical knowledge, regulatory compliance, and public health education.

Section 1Fundamental of Medical Affairs and Writing | Functional Role | Fundamental Sessions
Lecture 1Introduction tIntroduction to Medical Affairs | Definition | Objectives | Quadrants of Medical Affairs Functions | Exploring cross functional role of medical affairs Medical Affairs and Medical Writing | Fundamental Sessions
Lecture 2Dynamics of Medical Affairs Liaisons | MSLs – Functions and Responsibilities | Growth and demand of MSLs | Engagement of MSLs | MSL role in drug discovery development to commercialization
Lecture 3Medical Affairs Engagement in Pharma and Biopharma Strategic Management
Lecture 4Introduction to Medical Writing | Objective | Significance | Medical Writing Vs. Scientific Writing | Key Notes 
Lecture 5Types of Medical Writing | Regulatory Writing | CMC Writing | Clinical Writing | Documents under each class of medical writing  
Lecture 6Ethical Consideration of  Medical Writing | Important Considerations | Effective strategies for each ethical consideration | Case studies 
Lecture 7Regulatory Documents | Classification of regulatory documents | Understanding of each class of documents | Ethical consideration for Regulatory Writing
Lecture 8Publication Writing and Regulatory Writing | Key Differences with Examples 
Lecture 9Regulatory Writing - Review Test 
Section 2Discovery Development | R&D Management | Regulations | Regulatory Writing
Lecture 10R&D Process & Introduction to drug discovery
Lecture 11Investigational New Drug Application (INDA)
Lecture 12New Drug Application (NDA) 
Lecture 13Basic concept and understanding of the Generic Drug
Lecture 14Abbreviated New Drug Application (ANDA) 
Lecture 15Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 16Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 17Purple Book: Significance | Searching | Assignments
Lecture 18Handling of orange book
Lecture 19USFDA expedited programs
Lecture 20Practical Training on INDA, NDA, ANDA filing
Lecture 21505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 22Authorized Generics: Key Understanding
Lecture 23Exploratory IND Vs. Traditional IND
Lecture 24Orphan Drug Designation 
Lecture 25Advance Learning on 505B2 Pathway
Lecture 26Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 27Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 28Review on Drug Discovery and Development 
Section 3Non-clinical and Clinical Writing
Lecture 29Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 30Clinical Trial Protocol Writing
Lecture 31Ethics in Clinical Research
Lecture 32Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 33FDA Forms and How to fill the resources
Lecture 34Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 35Importance and Significance of Phase 2b Clinical Trial 
Lecture 36Study Protocol Designing | Structure and Components of a Study Protocol | Checklist for study Protocol Designing
Lecture 37Hands on Case Study Protocol Designing for Experimental Asthma Drug | Analysis of various aspect of protocol | Open File 
Lecture 38Drafting Study Objective Methodology Endpoint | Practical Orientation
Lecture 39Informed Consent | Key Elements | Drafting Informed Consent
Lecture 40Strategies to Develop consent form
Lecture 41IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 42Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 43IB Writing Skill Training
Lecture 44CSR - Clinical Study Report Preparation
Lecture 45CSR Data Presentation and Analysis
Section 4Regulatory Submission Strategic Planning
Lecture 46Regulatory Strategies in different phases of Clinical Trial
Lecture 47Para IV Filing - Strategic Insight
Lecture 48Para IV Notices
Lecture 49Evergreening - Patent Life Extension Strategies
Lecture 50REMS Strategic Planning 
Lecture 51Compulsory Licensing
Lecture 52Licensing & Technology Transfer
Lecture 53LOE Strategies for Innovator Brands with case study
Lecture 54Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 55Drug Repurposing
Lecture 56Advance understanding of the portfolio Management 
Lecture 57New Indication Approval Process and Promotion 
Lecture 58OTC Switch 
Lecture 59Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 60NCE Vs. 505b2 application - Case Based Learning 
Lecture 61FTF - 180 Days Exclusivity - Case Based Learning
Lecture 62Classic case study of the 505b2 filing : Case Based Learning
Lecture 63Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 64Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 65Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 5Bioequivalence Study : Requirements
Lecture 66PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 67Bioequivalence Study | Study design | Different types of BE Studies
Lecture 68Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 69Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 70Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 71Bioequivalence Study - Discussion - Dissolution Testing
Lecture 72Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 6Market Access of Pharma and Biologics
Lecture 73Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 74Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 75Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 76Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 77Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 78AMCP Market Access Dossier Preparation 
Lecture 79Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 80Pharma Market Access Pricing Case Study: interchangeable Pricing 
Section 7Pricing and Reimbursements
Lecture 81Drug Pricing Methodologies
Lecture 82Drug Pricing Methodologies - II
Lecture 83Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 84Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 85Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 86Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 8Evidence Generation | Real World Data | Real World Evidence
Lecture 87Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 88RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 89RWD and RWE in Product Lifecycle Management
Lecture 90RWD and RWE - Fit to use | Assessment
Lecture 91RWD data sources | Different types | Detailed understanding of each class 
Section 9Drug Safety | Pharmacovigilance
Lecture 92Introduction to Pharmacovigilance
Lecture 93Adverse Drug Reactions
Lecture 94ADR: Pharmacology
Lecture 95ADR: Classification
Lecture 96PV and ADR Monitoring
Lecture 97ADR and Related Terminologies
Lecture 98ADR Reporting System 
Lecture 99DoTS
Lecture 1004 Elements of AEs
Lecture 101ADR Reporting Limitations
Lecture 102ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 103The Adverse Drug Reaction (ADR) Probability Scale
Lecture 104Pharmacovigilance Process
Lecture 105PSURs
Lecture 106Risk Management
Section 10Regulatory Submission Management | Regulatory CMC Writing
Lecture 107Common Technical Document (CTD)
Lecture 108CMC Dossier & Compliance Management
Lecture 109Electronic Common Technical Document (ECTD)
Lecture 110Key Consideration for Drug Master File Preparation and Submission 
Lecture 111Practical Understanding on Drug Master File Preparation and Submission
Lecture 112Site Master File - Detailed Understanding 
Lecture 113Importance of effective dossier management
Lecture 114Discussion on 85 common deficiencies in CTD submission dossier
Lecture 115Detailed Understanding on ANDA Submission Dossier 
Section 11Medical Writing Style Guide
Lecture 116In-depeth understanding on Medical Writing Style Guide
Lecture 117AMA Manual of Style
Lecture 118Key Medical Writing Standards
Lecture 119Medical Writing Tool 1
Lecture 120Medical Writing Tool 2
Lecture 121Medical Writing Tool 3
Lecture 122Medical Writing Tool 4
Lecture 123Medical Writing Tool 5
Lecture 124Medical Writing Tool 6
Lecture 125Medical Writing Tool 7
Lecture 126Medical Writing Tool 8
Lecture 127Medical Writing Tool 9
Lecture 128Medical Writing Tool 10
Section 12Scientific Writing and Medical Communication
Lecture 129Brand Name, Brand Logo and Trademarking
Lecture 130Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 131Trademark Searching Process | Hands on Practical Training
Lecture 132How to design an excellent brand logo : Tricks of the trade
Lecture 133Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 134Brand Logo Development: Real Life Simulation
Lecture 135Tagline - Development, Finalization and Protection
Lecture 136Brand Tagline - Punchline
Lecture 137Pharma Brand Name Generator
Lecture 138Pharma Marketing Plan | Definition | Importance | Key areas to consider while preparing Marketing Plan
Lecture 139Core Section of  Pharma Marketing Plan | Example of each content of each section | Marketing Plan Core Section analysis with real life example
Lecture 140Marketing Campaign | Introduction | Objective |  Types| Campaign Matrix Preparation | Campaign Matrix Practical Examples | Sample Campaign Matrix with timeline and action plan for brands
Lecture 141Target Based Marketing Campaign Designing | HCPs Targeting | Retailer-Distributor Targeting | Targeting Sales Team 
Lecture 142Building Prescriber’s Loyalty through Marketing Campaign :  Pharmaceutical Prescriber’s Matrix – Strategic Campaign Preparation | Short Term Vs. Long Term Campaign  
Lecture 143Marketing Planning Cycle |  Content writing for each planning stage | Case Study - Preparing Marketing Planning Cycle with real life example 
Lecture 144Creative Brief Preparation |  Campaign Brief | Case Study - Campaign Brief Preparation of Pharma Brands 
Lecture 145Sample Marketing Plan | Predesigned Brand Plan | Open format Workfile (Download)
Lecture 146Practical Training on Marketing Plan Presentation Preparation with real life example | Predesigned Brand Plan | Walkthrough Session with detailed analysis 
Lecture 147Pharma Brand Launch Workflow | Prelaunch | Launching | Post Launch Activities 
Lecture 148Promotional visual aid designing  | V3M Concept | Components of the visual aid page | Component of Visual Aid designing
Lecture 149Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid
Lecture 150Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors
Lecture 151Visual Aid Analysis with practical example
Lecture 152Guideline on Visual Aid Development
Lecture 153Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 154Visual aid detailing story writing