Introduction
Features
Course Outline
Related Courses
About Medical Affairs
🚀 Medical Affairs is No Longer a Support Function — It is a Strategic Leadership Role in Pharma.
In today’s pharmaceutical and healthcare ecosystem, Medical Affairs professionals act as the scientific bridge between research, clinical practice, and commercial strategy.
Therefore, success in Medical Affairs requires more than scientific expertise. It demands strategic thinking, evidence generation capabilities, regulatory understanding, and the ability to translate complex science into real clinical value.
At Royed Training, the Medical Affairs Training Program is designed to develop next-generation Medical Affairs professionals who can confidently operate across the pharmaceutical value chain.
Our Medical Affairs Training Program is designed to empower healthcare professionals with the skills, knowledge, and strategic insights necessary to excel in the multifaceted field of Medical Affairs. Whether you are a seasoned professional or an emerging talent, this program provides a tailored learning experience that aligns with the evolving demands of the healthcare industry.
Who should attend this course?
- Certified medical degree holders who want to make a career in medical affairs and medical writing.
- Professional who are working dedicatedly in Medical Science Liaisons.
- Medical Information Specialists.
- Regulatory Affairs Professionals.
- Health Economists.
- Market Access Specialists.
- Pharmacovigilance Experts.
- Healthcare Professionals Transitioning to Medical Affairs.
Key details about the course:
- Course Code: RYD-115
- Title: PG Certification in Medical Affairs (PGCMA)
- Type of the course: 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 Year. Course can completed within 1 year 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.
In an era where the healthcare landscape is continuously evolving, our Medical Affairs Training Program is your gateway to excellence. Elevate your career, contribute to meaningful advancements in healthcare, and be a driving force in shaping the future of Medical Affairs. Join us on this transformative journey towards a more knowledgeable, skilled, and empowered healthcare workforce.
Core Learning Areas of Medical Affairs Course
🔬 Medical Affairs Strategy & Functional Roles
📊 Real World Evidence (RWE) & Evidence Generation
💊 Pharmacoeconomics, HEOR & Value Demonstration
🌍 Market Access, Pricing & Reimbursement Strategy
📑 Regulatory Affairs & Scientific Compliance
⚕️ Safety, Pharmacovigilance & Risk Communication
📈 Portfolio Strategy, Forecasting & Lifecycle Management
🤝 Scientific Engagement with Healthcare Professionals
🤖 Practical AI Training for Medical Affairs Professionals — including hands-on exposure to AI tools for scientific insights, evidence analysis, medical content generation, and strategic decision support
Case Based Learning
- Advance training on strategic management based on the various business regions.
- 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.
Course Outline
Royed Training’s medical affairs training course is meticulously designed to equip participants with the knowledge, skills, and practical insights necessary to excel in the dynamic and demanding field of medical affairs. With a comprehensive and up-to-date curriculum, the course ensures that participants are well-prepared to navigate the complexities of pharmaceutical and healthcare industries with confidence and competence.
Introduction to Medical Affairs
- Overview of the role of medical affairs in pharmaceutical and healthcare industries
- Historical evolution and current trends in medical affairs
- Importance of medical affairs in supporting the product lifecycle
Regulatory Environment and Compliance
- Understanding regulatory bodies (e.g., FDA, EMA) and their requirements
- Compliance standards and guidelines (e.g., Good Clinical Practice, Good Pharmacovigilance Practice)
- Adherence to ethical standards and codes of conduct
- Understanding of drug dossier and cmc writing.
- Hands on understanding on effective management of Response to Queries (RTQs)
Medical Communications and Scientific Exchange
Medical Affairs course covers effective communication strategies, handling scientific inquiries, and building relationships with key opinion leaders are emphasized, enabling participants to excel in conveying complex medical information effectively. It has following core areas:
- Effective communication strategies for medical professionals
- Handling scientific inquiries and medical information requests
- Building and maintaining relationships with key opinion leaders (KOLs)
- Advocacy management
Clinical Development and Trials
- Basics of clinical trial design and methodology
- Role of medical affairs in supporting clinical trials
- Interpreting clinical trial data and implications for product development
Pharmacovigilance and Drug Safety
- Reporting and monitoring adverse events
- Risk management strategies
- Post-marketing surveillance and safety updates
Market Access and Health Economics and Outcomes Research (HEOR)
- Introduction to market access, health economics and its relevance to medical affairs
- Conducting outcomes research and real-world evidence generation
- Utilizing HEOR data in market access and reimbursement strategies
Medical Affairs in Pharma Marketing, Product Launch and Lifecycle Management
- Planning and executing product launches
- Lifecycle management strategies
- Managing scientific publications and presentations
Medical Information and Training
- Developing and disseminating medical content
- Providing training to internal stakeholders (sales, marketing, etc.)
- Ensuring accurate and up-to-date medical information resources
Cross-functional Collaboration
Collaboration with other departments is the key for success. This fosters a culture of teamwork and alignment across functions to achieve organizational objectives effectively. This section deals with cross functional collaboration of medical affairs professionals.
- Collaborating with other departments (e.g., marketing, regulatory affairs)
- Role of medical affairs in cross-functional teams
- Effective communication and alignment across departments
- Professional Development and Career Growth
- Continuing education opportunities for medical affairs professionals
- Skills development in critical areas (e.g., leadership, project management)
- Career paths and advancement opportunities in medical affairs
Few of the similar courses
- Life Science Business Consulting
- Pharma Global Management
- International Drug Regulatory Affairs
- Medical Devices Global Business Course
- Pharma Strategic Management Course
- Pharma Business Development and Licensing
- US Pharmaceutical and Biopharmaceutical Regulatory Affairs
- Drug Discovery and Development to Commercialization
- HEOR
- Market Access
Career in Medical Affairs
Medical Affairs is a critical function within the pharmaceutical, biotechnology, and medical device industries. In fact, medical affairs professionals are responsible for communicating accurate and unbiased information about a company’s products and services to healthcare professionals, regulators, and patients. Professionals working in medical affairs also play a key role in developing and implementing post-market surveillance strategies to ensure the safe and effective use of a company’s products.
Medical Affairs and Medical Writing : Are they same?
Both medical affairs and medical writing are closely related fields, but they have distinct roles and responsibilities. But medical affairs professionals are responsible for the overall medical strategy and communication of a company’s products and services, while medical writers are responsible for the creation of specific written materials.
Professionals working in Medical affairs department have a broad range of responsibilities, including:
- Developing and implementing medical strategies
- Communicating with healthcare professionals, regulators, and patients
- Developing and implementing post-market surveillance strategies
- Managing medical information resources
- Supporting clinical trials
The Medical writers are responsible for creating a variety of written materials, including:
- Clinical study reports
- Regulatory submissions
- Medical journal articles
- Patient education materials
- Marketing materials
To conclude, medical writers typically work under the direction of medical affairs professionals. They may also work with other professionals, such as scientists, engineers, and regulatory experts.
Section 1Fundamental of Medical Affairs | Dynamics | Functional Roles
Lecture 1Introduction to Medical Affairs | Definition | Objectives | Quadrants of Medical Affairs Functions | Exploring cross functional role of medical affairs
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 4Patient Centricity in MSL | Importance and Significance of Patient Centricity | Simulation - KOL management
Lecture 5Medical Affairs in Product Life Cycle Management | Medical Affairs function in R&D and Commercial Phase | Adoption Curve | Simulations
Lecture 6Medical Affairs Functional Matrix
Lecture 7Medical Affairs - Key Activities
Lecture 8Job Role - Medical Advisor
Lecture 9Job Role - MSL - Role and Responsibilities
Section 2Discovery Development | R&D Management | Regulations
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 24Patents Vs. exclusivity
Lecture 25Orphan Drug Designation
Lecture 26Advance Learning on 505B2 Pathway
Lecture 27Chemistry, Manufacturing & Controls
Lecture 28Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 29Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 30Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 31Drug Repurposing
Lecture 32Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 33NCE Vs. 505b2 application - Case Based Learning
Lecture 34FTF - 180 Days Exclusivity - Case Based Learning
Lecture 35Classic case study of the 505b2 filing : Case Based Learning
Lecture 36What is meaning of 'Pipeline in a Molecule'?
Lecture 37USFDA Emergency Use Authorization (EUA)
Lecture 38Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 39Review on Drug Discovery and Development
Section 3Non-clinical and Clinical Development
Lecture 40Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 41Clinical Trial Protocol Writing
Lecture 42Ethics in Clinical Research
Lecture 43Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 44FDA Forms and How to fill the resources
Lecture 45Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 46Importance and Significance of Phase 2b Clinical Trial
Section 4Portfolio Strategic Management
Lecture 47Regulatory Strategies in different phases of Clinical Trial
Lecture 48Para IV Filing - Strategic Insight
Lecture 49Para IV Notices
Lecture 50Evergreening - Patent Life Extension Strategies
Lecture 51Pay For Delay Strategy
Lecture 52REMS Strategic Planning
Lecture 53Compulsory Licensing
Lecture 54Licensing & Technology Transfer
Lecture 55In-Licensing Vs. Outlicensing
Lecture 56LOE Strategies for Innovator Brands with case study
Lecture 57Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 58Drug Repurposing
Lecture 59Advance understanding of the portfolio Management
Lecture 60New Indication Approval Process and Promotion
Lecture 61OTC Switch
Lecture 62Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 63NCE Vs. 505b2 application - Case Based Learning
Lecture 64FTF - 180 Days Exclusivity - Case Based Learning
Lecture 65Classic case study of the 505b2 filing : Case Based Learning
Lecture 66Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 67What is meaning of 'Pipeline in a Molecule'?
Lecture 68USFDA Emergency Use Authorization (EUA)
Lecture 69Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 70Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 71Review on Drug Discovery and Development
Section 5Bioequivalence Study : Requirements
Lecture 72PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 73Bioequivalence Study | Study design | Different types of BE Studies
Lecture 74Bioequivalence 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 75Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 76Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 77Bioequivalence Study - Discussion - Dissolution Testing
Lecture 78Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 6Pharmacoeconomics | HEOR
Lecture 79Introduction to Health Economics | Key terminologies related to health economics.
Lecture 80HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 81Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 82Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 83Core fundamentals of Health Economics | Clinical and economic burden | Public Health Care Payer Vs. Patient and Societal | Positioning a new treatment with the current treatment | QALY | ICER | Threshold value | Clinical trials vs health economics assessment
Lecture 84Pharmacoeconomic Evaluation Checklist | Health Economics Map | Economic evaluation cycle | Checklist of economic evaluation | Costs and Outcome relevant to different groups | Comparators | Problem of choosing the comparators
Lecture 85Pharmacoeconomic Evaluation - Resource and Cost | Fixed, Variable and Total Cost | Calculation | Average vs. marginal cost | Importance of marginal cost | Discounting | Discounting calculation | Preferable discounting rate | Sources of unit cost data | Reference costs
Lecture 86Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATP
Lecture 87Patient Based Forecasting Model | Applying more filters and variables
Lecture 88QALY | How to calculate QALY | Importance and Significance
Lecture 89ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 90CER and PCOR
Section 7Market Access of Pharma and Biologics
Lecture 91Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 92Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 93Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 94Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 95Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 96AMCP Market Access Dossier Preparation
Lecture 97Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 98Pharma Market Access Pricing Case Study: interchangeable Pricing
Section 8Pharma Forecasting
Lecture 99Sales Forecasting in Life Science Industry
Lecture 100New Product Forecast Algorithm
Lecture 101Patient Based Forecasting Model | Applying more filters and variables
Lecture 102Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 103Prevalence Vs. Incidence Model
Lecture 104EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 105Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 106Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 107Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 108Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 109Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 110Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 111Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 112Simulation on Bottom-up forecasting
Lecture 113Assessment on Bottom-up forecasting
Lecture 114Oncology Brand Forecasting
Lecture 115Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 116Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 117First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 118Forecasting Biosimilar | Key Factors to consider
Lecture 119Consensus Meeting
Lecture 120One Number Vs. Multi Number Forecasting
Lecture 121Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 122Treatment Algorithm and Forecasting : Case Based Learning
Lecture 123Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 124Prescription Value Calculation
Section 9Pricing and Reimbursements
Lecture 125Drug Pricing Methodologies
Lecture 126Drug Pricing Methodologies - II
Lecture 127Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 128Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 129Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 130Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 10Evidence Generation | Real World Data | Real World Evidence
Lecture 131Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 132RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 133RWD and RWE in Product Lifecycle Management
Lecture 134RWD and RWE - Fit to use | Assessment
Lecture 135RWD data sources | Different types | Detailed understanding of each class
Section 11Pharma Digital Marketing
Lecture 136Introduction to Digital Marketing
Lecture 137Inbound and outbound marketing in pharma | Types of inbound and outbound marketing
Lecture 138Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 139Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 140Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 141Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 142Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 143Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 144Web Host - Check the hosting details
Lecture 145Page Speed- importance and practical understanding | Check the web speed
Lecture 146Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 147Mobile Responsive | Tracking the Site
Lecture 148HCP sites and Patient Site
Lecture 149Google Ad - Practical Training on Campaign Development and Execution
Lecture 150Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 151Brand Portal Development
Lecture 152Relationship Marketing : KOL Management and Patient Advocacy Group
Lecture 153Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 154Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 155Difference between FMCG and OTC Brand Ad
Lecture 156Digital Marketing Techniques
Lecture 157Video Marketing
Lecture 158Video Marketing Techniques For Small Business Owners
Lecture 159Promoting Brand through Article Advertising and Marketing
Section 12Lead Generation | Management | Deal Structuring | Implementation
Lecture 160Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 161Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 162Compound Annual Growth Rate | CAGR Calculation
Lecture 163Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 164Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 165Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 166Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 167Numerical SWOT Practical training
Lecture 168Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 169Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 170Forecasting : Tools and Techniques
Lecture 171Market Sizing & Forecasting Case Study
Lecture 172Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 173Average Royalty Rate
Lecture 174Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 175Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 176Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 177Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 178SPECIAL PURPOSE VEHICLES (SPV)
Lecture 179Indication Splitting | Concept | Implementation feasibility analysis
Lecture 180Types of Deals from Discovery to Commercialization
Lecture 181What are the fundamental areas of business development
Lecture 182Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 183Licensing Payment Scheduling: Different Types
Lecture 184Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 185Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 186Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 187Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 188Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms
Lecture 189Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Section 13Drug Safety | Pharmacovigilance
Lecture 190Introduction to Pharmacovigilance
Lecture 191Adverse Drug Reactions
Lecture 192ADR: Pharmacology
Lecture 193ADR: Classification
Lecture 194PV and ADR Monitoring
Lecture 195ADR and Related Terminologies
Lecture 196ADR Reporting System
Lecture 197DoTS
Lecture 1984 Elements of AEs
Lecture 199ADR Reporting Limitations
Lecture 200ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 201The Adverse Drug Reaction (ADR) Probability Scale
Lecture 202Pharmacovigilance Process
Lecture 203PSURs
Lecture 204Risk Management
Section 14Regulatory Submission Management | Regulatory CMC Writing
Lecture 205Common Technical Document (CTD)
Lecture 206CMC Dossier & Compliance Management
Lecture 207Electronic Common Technical Document (ECTD)
Lecture 208Key Consideration for Drug Master File Preparation and Submission
Lecture 209Practical Understanding on Drug Master File Preparation and Submission
Lecture 210Site Master File - Detailed Understanding
Lecture 211Importance of effective dossier management
Lecture 212Discussion on 85 common deficiencies in CTD submission dossier
Lecture 213Detailed Understanding on ANDA Submission Dossier
Section 15Preparing Clinical Study Report
Lecture 214How to prepare and write clinical study report
Lecture 215Example of Clinical Study Report : new medication for treating hypertension
Lecture 216Compare Clinical Study Report of 2 comparing medication
Lecture 217How to interpret clinical study report
Lecture 218Understanding RCT
Lecture 219Understanding Blinding
Lecture 220Publishing Clinical Study Reports
Section 16AI in Medical Affairs and Medical Writing
Lecture 221Introduction to AI
Lecture 222Basics of AI ML DL | Key Differences | Application in industry
Lecture 223Types of AI
Lecture 224AI Project | Overview
Lecture 225Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 226How machine learning
Lecture 227Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 228Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 229AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 230AI Terms with Regulatory Significance | Regulatory Applications
Lecture 231NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 232Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 233Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 234AI Data Quality Standard | Checklist
Lecture 235Download AI Data Quality Checklist
Lecture 236Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 237AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 238AI Technologies in RA
Lecture 239Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 240Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 17AI in Regulatory Authoring and CMC Writing
Lecture 241AI in Regulatory Authoring and CMC Writing
Lecture 242AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 243Tips for Selecting AI Tools (CMC Authoring)
Lecture 244CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 245HITL Regulatory Document Authoring
Lecture 246Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 247Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 18Publishing and Advanced eCTD v4.0 Training
Lecture 248eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 249eCTDV4.0 Structure | Lifecycle Management
Lecture 250eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 251eCTD Validation Tools
Lecture 252eCTD Publishing Cycle
Lecture 253HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 254Tips and Submission Readiness Checklist
Lecture 255eCTD Submission Checklist Format
Lecture 256Regulatory Publishing Document Control Challenges
Lecture 257Document Control Checklist
Lecture 258Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 259Formatting Rules Templated and Agency Specification
Lecture 260Versioning for Regulatory Publishing
Lecture 261File Naming Standard
Lecture 262Text Recognition and Optical Character Recognition (OCR)
Lecture 263Versioning File Naming OCR - How they work together
Lecture 264Final Document Assembly
Lecture 265Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 266TOC and CI Management
Lecture 267Initial Submission & Maintenance Submission
Lecture 268Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 269eCTD Dossier Lifecycle - Multi Sequence View
Lecture 27010 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 271Global Decision Tree - Classifying Post Approval Changes
Lecture 272eCTD Technical Validation | Typical issues | Resolutions
Lecture 273eCTD Validation Readiness Checklist
Lecture 274QC Checklist Design and Pre Submission Review
Lecture 275Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 276Regulatory Publishing Simulation
Lecture 277Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 19Data Integrity issues in Medical Writing : Detailed Understanding
Lecture 278Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 279Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 280Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 281RTQs | Response to Queries | How to handle Regulatory Queries
Lecture 282AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 283Cases of data breaches with explanation
Lecture 284Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 20Labelling and Artwork Management in Medical Affairs
Lecture 285Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 286Types of Labels
Lecture 287Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 288Global Artwork Labelling Framework | 5 Case Simulation
Lecture 289Country-Specific Labelling Requirements
Lecture 290Summary of Product Characteristics (SmPC)
Lecture 291Patient Information Leaflet (PIL)
Lecture 292Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 293Patient Information Leaflet (PIL) – Review Checklist
Lecture 294US Prescribing Information (PI) | Differences with EU SmPC
Lecture 295US Prescribing Information (PI) - Review Checklist
Lecture 296Fundamental Understanding on Medication Guide
Lecture 297Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 298Medication Guide - Review Checklist | Inspection Checklist
Lecture 299PI Vs. Medication Guide Comparison
Lecture 300Patient Information Leaflet (PIL) vs Medication Guide
Lecture 301Label Components | Key considerations for effective designing of label
Lecture 302Label Review Checklist
Lecture 303Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 304Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 305Instruction for Use (IFU) | Design and Development of IFU
Lecture 306UDI | Different Component | How to design
Lecture 307Implant Card | Regulatory Importance | Content | How to design
Lecture 308Color Proofing, Dielines & Version Control"
Lecture 309CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 310Injection Labels - Labels and Cartons
Lecture 311Various Design Component Placement Understanding (Injectables)
Lecture 312Concept of Logo File | Open and Curve File Importance
Lecture 313QC and Proof Reading in Labelling and Artwork
Lecture 314QC and Proofreading Checklist
Lecture 315Template Management and Creative Brief
Lecture 316Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 317Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 318Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 319Bulk Pack Labelling
Lecture 320Bulk Pack Labelling Checklist
Lecture 321OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 322OTC vs Prescription (Rx) Label Checklist
Lecture 323OTC Approval Matrix
Lecture 324OTC Claim Risk Scoring System
Section 21CCDS Management Training for Medical Affairs Professionals
Lecture 325CCDS Management
Lecture 326CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 327AI Augmented Labelling Compliance System
Lecture 328Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 329AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 330CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 331CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 332Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 333Case Study on Centralized Artwork Operation [Recall Management]
Lecture 334Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 335Source Documents | Artwork Brief
Lecture 336Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies
Lecture 337Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes
Lecture 338Label Impact Assessment Checklist
Lecture 339Packaging Types & Their Impact on Artwork
Lecture 340Design tool used in artwork | Esko Platform | Adobe Illustrator | CorelDRAW | File Format | Label Design Workflow and Tool Utilization
Lecture 341Labelling Management System (LMS) | Understanding of Popular LMS Softwares | Workflow Management | Workflow Automation & Version Tracking | Best Practices
Section 22Real World Evidence and Real World Data | Strategic Decision Making
Lecture 342Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 343RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 344RWD and RWE in Product Lifecycle Management
Lecture 345RWD and RWE - Fit to use | Assessment
Lecture 346RWD data sources | Different types | Detailed understanding of each class
Lecture 347RWD Study Design
Lecture 348RWE Published Tool | Insights on commonly used tools
Lecture 349Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 350Consensus Narrative Review
Lecture 351Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 352Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 353RWD Characteristics
Lecture 354RCT vs. RWE Comparison | Case Based Analysis
Lecture 355RCT and RWE Comparison
Lecture 356Introduction to Healthcare Datasets
Lecture 357Dataset 1: Claims Data (Insurance)
Lecture 358Dataset 2: Retail Pharmacy Prescription Data
Lecture 359Dataset 3: Longitudinal Patient Data
Lecture 360Characteristics of Different Set of Healthcare Data
Lecture 361Reimbursement and Pricing Datasets
Lecture 362RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 363Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 364RWD & RWE Case Database
Lecture 365RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 23AI Tools, Ethics and Future Landscape
Lecture 366AI Reg Tools - Review | Understanding Capabilities
Lecture 367Regulatory Authority View on AI Adoption
Lecture 368Data Sensitivity | Levels | Consequences | Management
Lecture 369Governance Flowchart – AI Tools in GxP Environments
Lecture 370Generalist Vs. Specialist AI Tools
Lecture 371AI Generalist Overview (Life Science Focus)
Lecture 372Horizontal vs Vertical AI Tools
Lecture 373AI Tool Assessment Test
Lecture 374Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 24Prompt Engineering in Medical Affairs
Lecture 375Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 376Special Prompting Structure - Case Based Prompt Designing
Lecture 377Special Prompting Structure - Case Based Prompt Designing
Lecture 378PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 379PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 380How to adjust the parameters | Techniques
Lecture 381Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
