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 1Fundamentals of 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 7Evolution & Strategic Role of Medical Affairs in Pharma
Lecture 8Medical Affairs Responsibility Matrix (RACI)
Lecture 9Functional Boundaries: Medical vs Commercial vs Regulatory | MLR Review
Lecture 10Stakeholder Mapping & KOL Engagement in Medical Affairs
Lecture 11Medical Information & Scientific Response Writing (Core Writing Skill)
Lecture 12Advisory Boards & Scientific Meetings: Execution, Strategy & Medical Writing Integration
Lecture 13Publication Planning & Scientific Dissemination (Writing-Intensive Module)
Lecture 14Publication Writing Workbook | Medical Affairs & Scientific Writing – Solved Exercises
Lecture 15IMRAD Format (Medical & Scientific Writing Standard)
Lecture 16Case Based IMRAD Examples (Multi-Therapy Areas)
Lecture 17Medical Scientific Response Writing
Lecture 18Advisory Boards & Scientific Meetings: Execution, Strategy & Medical Writing Integration
Lecture 19KOL Management and Patient Advocacy Group
Lecture 20Medical Affairs Publication Planning | Types of Scientific Publications | Key components | Timeline | Planning Formats
Lecture 21IMRAD Format (Medical & Scientific Writing Standard)
Lecture 22Publication Writing Examples - Medical Affairs and Scientific Writing
Lecture 23IMRAD Examples - Multi Therapy Areas
Lecture 24Clinical Trial Design : Superiority vs Non-Inferiority vs Equivalence Trials
Lecture 25Endpoint Interpretation: Primary, Secondary & Surrogate Endpoints | Simulations
Lecture 26Safety Data Interpretation: AE, SAE & Signal Detection | Core Understanding | Simulations | Assignment
Lecture 27Benefit–Risk Assessment & Clinical Decision Writing | Scenario Based Case Discussion
Lecture 28The Scientific Blueprint of Medical Affairs Strategy
Lecture 29Medical Affairs Strategy Explainer
Lecture 30Precision KOL Engagement | Master Workflow | Building the KOL Universe | The Data-Driven Scoring Engine | Segmentation Architecture Matrix | Designing the Annual Engagement Plan (AEP)
Lecture 31Advanced KOL Engagement
Lecture 32Scientific Publication Governance | Authorship Roles & Responsibilities: Diagnostic Matrix | ICMJE Authorship Framework | Presubmission Decision Framework
Lecture 33Authorship Integrity | Gift Authorship | Ghost Authorship | Governance Framework | Simulations
Lecture 34Introduction to MI Workflow | Fundamenatal Understanding | SLA | Quality Matrix and Audits
Section 2Discovery Development | R&D Management | US Regulations
Lecture 35R&D Process & Introduction to drug discovery
Lecture 36Investigational New Drug Application (INDA)
Lecture 37New Drug Application (NDA)
Lecture 38Basic concept and understanding of the Generic Drug
Lecture 39Abbreviated New Drug Application (ANDA)
Lecture 40Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 41Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 42Purple Book: Significance | Searching | Assignments
Lecture 43Handling of orange book
Lecture 44USFDA expedited programs
Lecture 45Preformulation Study in Drug Development
Lecture 46Regulatory Requirements for Preformulation Study
Lecture 47Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 48Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 49Types and Timing of Non-clinical Studies
Lecture 50Exploratory IND Vs. Traditional IND
Lecture 51Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 52Orphan Drug Designation
Lecture 53Review on Drug Discovery and Development
Lecture 54Understanding on Clinical Trials and Clinical Research
Lecture 55Clinical Trial Protocol Writing
Lecture 56Ethics in Clinical Research
Lecture 57Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 58FDA Forms and How to fill the resources
Lecture 59Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 60Chemistry, Manufacturing & Controls
Lecture 61Fundamental 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 62505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 63Advance Learning on 505B2 Pathway
Lecture 64Authorized Generics: Key Understanding
Lecture 65Complete Response Letter | Key understanding | Management and Action Plan
Lecture 66Introduction to ICH | Members | Guidelines
Lecture 67ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 68ICH Q2 : Analytical Validation
Lecture 69ICH Q3 : Impurities
Lecture 70Rest of ICH Q Family Guidelines
Lecture 71Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Section 3EU Regulation and Authorization Planning
Lecture 72EU Regulatory System Fundamentals
Lecture 73Introduction to EU Regulation
Lecture 74Orientation to European Countries and National Regulatory Bodies
Lecture 75EMA and EMA Authorisation Process
Lecture 76Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 77EU MA Application Types and Strategic Planning
Lecture 78EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 79EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 80Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 81Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 82Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 83Centralised Procedure Timetable and Review Logic
Lecture 84DCP / MRP / National Procedure – Practical Workflow Module
Lecture 85EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 86DCP vs MRP Timeline
Lecture 87EU Adaptive Pathway
Lecture 88European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 89SPOR - Concept of Master Data Management
Lecture 90The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 91LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 92Response to list of Questions (LoQ)
Lecture 93Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 94Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 95CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 96Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 97Compassionate Use
Lecture 98EU Prime Designation
Lecture 99MHRA - UK Regulation
Lecture 100Summary of Product Characteristics
Lecture 101Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 102Accelerated assessment by EMEA
Lecture 103Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 104Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Section 4Portfolio Strategic Management
Lecture 105Regulatory Strategies in different phases of Clinical Trial
Lecture 106Para IV Filing - Strategic Insight
Lecture 107Para IV Notices
Lecture 108Evergreening - Patent Life Extension Strategies
Lecture 109Pay For Delay Strategy
Lecture 110REMS Strategic Planning
Lecture 111Compulsory Licensing
Lecture 112Licensing & Technology Transfer
Lecture 113In-Licensing Vs. Outlicensing
Lecture 114LOE Strategies for Innovator Brands with case study
Lecture 115Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 116Drug Repurposing
Lecture 117Advance understanding of the portfolio Management
Lecture 118New Indication Approval Process and Promotion
Lecture 119OTC Switch
Lecture 120Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 121NCE Vs. 505b2 application - Case Based Learning
Lecture 122FTF - 180 Days Exclusivity - Case Based Learning
Lecture 123Classic case study of the 505b2 filing : Case Based Learning
Lecture 124Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 125What is meaning of 'Pipeline in a Molecule'?
Lecture 126USFDA Emergency Use Authorization (EUA)
Lecture 127Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 128Fundamental 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 129Review on Drug Discovery and Development
Section 5Bioequivalence Study : Requirements
Lecture 130PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 131Bioequivalence Study | Study design | Different types of BE Studies
Lecture 132Bioequivalence 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 133Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 134Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 135Bioequivalence Study - Discussion - Dissolution Testing
Lecture 136Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 6Pharmacoeconomics | HEOR
Lecture 137Introduction to Health Economics | Key terminologies related to health economics.
Lecture 138HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 139Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 140Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 141Core 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 142Pharmacoeconomic 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 143Pharmacoeconomic 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 144Pharmacoeconomic 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 145Patient Based Forecasting Model | Applying more filters and variables
Lecture 146QALY | How to calculate QALY | Importance and Significance
Lecture 147ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 148CER and PCOR
Section 7Market Access of Pharma and Biologics
Lecture 149Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 150Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 151Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 152Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 153Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 154AMCP Market Access Dossier Preparation
Lecture 155Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 156Pharma Market Access Pricing Case Study: interchangeable Pricing
Section 8Pharma Forecasting
Lecture 157Sales Forecasting in Life Science Industry
Lecture 158New Product Forecast Algorithm
Lecture 159Patient Based Forecasting Model | Applying more filters and variables
Lecture 160Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 161Prevalence Vs. Incidence Model
Lecture 162EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 163Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 164Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 165Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 166Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 167Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 168Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 169Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 170Simulation on Bottom-up forecasting
Lecture 171Assessment on Bottom-up forecasting
Lecture 172Oncology Brand Forecasting
Lecture 173Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 174Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 175First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 176Forecasting Biosimilar | Key Factors to consider
Lecture 177Consensus Meeting
Lecture 178One Number Vs. Multi Number Forecasting
Lecture 179Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 180Treatment Algorithm and Forecasting : Case Based Learning
Lecture 181Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 182Prescription Value Calculation
Section 9Pricing and Reimbursements
Lecture 183Drug Pricing Methodologies
Lecture 184Drug Pricing Methodologies - II
Lecture 185Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 186Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 187Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 188Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 10Evidence Generation | Real World Data | Real World Evidence
Lecture 189Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 190RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 191RWD and RWE in Product Lifecycle Management
Lecture 192RWD and RWE - Fit to use | Assessment
Lecture 193RWD data sources | Different types | Detailed understanding of each class
Section 11Pharma Digital Marketing
Lecture 194Introduction to Digital Marketing
Lecture 195Inbound and outbound marketing in pharma | Types of inbound and outbound marketing
Lecture 196Digital 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 197Digital 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 198Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 199Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 200Campaign 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 201Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 202Web Host - Check the hosting details
Lecture 203Page Speed- importance and practical understanding | Check the web speed
Lecture 204Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 205Mobile Responsive | Tracking the Site
Lecture 206HCP sites and Patient Site
Lecture 207Google Ad - Practical Training on Campaign Development and Execution
Lecture 208Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 209Brand Portal Development
Lecture 210Relationship Marketing : KOL Management and Patient Advocacy Group
Lecture 211Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 212Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 213Difference between FMCG and OTC Brand Ad
Lecture 214Digital Marketing Techniques
Lecture 215Video Marketing
Lecture 216Video Marketing Techniques For Small Business Owners
Lecture 217Promoting Brand through Article Advertising and Marketing
Section 12Lead Generation | Management | Deal Structuring | Implementation
Lecture 218Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 219Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 220Compound Annual Growth Rate | CAGR Calculation
Lecture 221Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 222Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 223Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 224Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 225Numerical SWOT Practical training
Lecture 226Modelling 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 227Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 228Forecasting : Tools and Techniques
Lecture 229Market Sizing & Forecasting Case Study
Lecture 230Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 231Average Royalty Rate
Lecture 232Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 233Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 234Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 235Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 236SPECIAL PURPOSE VEHICLES (SPV)
Lecture 237Indication Splitting | Concept | Implementation feasibility analysis
Lecture 238Types of Deals from Discovery to Commercialization
Lecture 239What are the fundamental areas of business development
Lecture 240Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 241Licensing Payment Scheduling: Different Types
Lecture 242Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 243Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 244Negotiation 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 245Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 246Types 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 247Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Section 13Drug Safety | Pharmacovigilance
Lecture 248Introduction to Pharmacovigilance
Lecture 249Adverse Drug Reactions
Lecture 250ADR: Pharmacology
Lecture 251ADR: Classification
Lecture 252PV and ADR Monitoring
Lecture 253ADR and Related Terminologies
Lecture 254ADR Reporting System
Lecture 255DoTS
Lecture 2564 Elements of AEs
Lecture 257ADR Reporting Limitations
Lecture 258ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 259The Adverse Drug Reaction (ADR) Probability Scale
Lecture 260Pharmacovigilance Process
Lecture 261PSURs
Lecture 262Risk Management
Section 14Regulatory Submission Management | Regulatory CMC Writing
Lecture 263Common Technical Document (CTD)
Lecture 264CMC Dossier & Compliance Management
Lecture 265Electronic Common Technical Document (ECTD)
Lecture 266Key Consideration for Drug Master File Preparation and Submission
Lecture 267Practical Understanding on Drug Master File Preparation and Submission
Lecture 268Site Master File - Detailed Understanding
Lecture 269Importance of effective dossier management
Lecture 270Discussion on 85 common deficiencies in CTD submission dossier
Lecture 271Detailed Understanding on ANDA Submission Dossier
Section 15Preparing Clinical Study Report
Lecture 272How to prepare and write clinical study report
Lecture 273Example of Clinical Study Report : new medication for treating hypertension
Lecture 274Compare Clinical Study Report of 2 comparing medication
Lecture 275How to interpret clinical study report
Lecture 276Understanding RCT
Lecture 277Understanding Blinding
Lecture 278Publishing Clinical Study Reports
Section 16AI in Medical Affairs and Medical Writing
Lecture 279Introduction to AI
Lecture 280Basics of AI ML DL | Key Differences | Application in industry
Lecture 281Types of AI
Lecture 282AI Project | Overview
Lecture 283Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 284How machine learning
Lecture 285Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 286Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 287AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 288AI Terms with Regulatory Significance | Regulatory Applications
Lecture 289NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 290Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 291Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 292AI Data Quality Standard | Checklist
Lecture 293Download AI Data Quality Checklist
Lecture 294Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 295AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 296AI Technologies in RA
Lecture 297Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 298Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 17AI in Regulatory Authoring and CMC Writing
Lecture 299AI in Regulatory Authoring and CMC Writing
Lecture 300AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 301Tips for Selecting AI Tools (CMC Authoring)
Lecture 302CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 303HITL Regulatory Document Authoring
Lecture 304Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 305Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 18Publishing and Advanced eCTD v4.0 Training
Lecture 306eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 307eCTDV4.0 Structure | Lifecycle Management
Lecture 308eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 309eCTD Validation Tools
Lecture 310eCTD Publishing Cycle
Lecture 311HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 312Tips and Submission Readiness Checklist
Lecture 313eCTD Submission Checklist Format
Lecture 314Regulatory Publishing Document Control Challenges
Lecture 315Document Control Checklist
Lecture 316Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 317Formatting Rules Templated and Agency Specification
Lecture 318Versioning for Regulatory Publishing
Lecture 319File Naming Standard
Lecture 320Text Recognition and Optical Character Recognition (OCR)
Lecture 321Versioning File Naming OCR - How they work together
Lecture 322Final Document Assembly
Lecture 323Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 324TOC and CI Management
Lecture 325Initial Submission & Maintenance Submission
Lecture 326Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 327eCTD Dossier Lifecycle - Multi Sequence View
Lecture 32810 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 329Global Decision Tree - Classifying Post Approval Changes
Lecture 330eCTD Technical Validation | Typical issues | Resolutions
Lecture 331eCTD Validation Readiness Checklist
Lecture 332QC Checklist Design and Pre Submission Review
Lecture 333Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 334Regulatory Publishing Simulation
Lecture 335Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 19Data Integrity issues in Medical Writing : Detailed Understanding
Lecture 336Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 337Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 338Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 339RTQs | Response to Queries | How to handle Regulatory Queries
Lecture 340AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 341Cases of data breaches with explanation
Lecture 342Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 20Labelling and Artwork Management in Medical Affairs
Lecture 343Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 344Types of Labels
Lecture 345Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 346Global Artwork Labelling Framework | 5 Case Simulation
Lecture 347Country-Specific Labelling Requirements
Lecture 348Summary of Product Characteristics (SmPC)
Lecture 349Patient Information Leaflet (PIL)
Lecture 350Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 351Patient Information Leaflet (PIL) – Review Checklist
Lecture 352US Prescribing Information (PI) | Differences with EU SmPC
Lecture 353US Prescribing Information (PI) - Review Checklist
Lecture 354Fundamental Understanding on Medication Guide
Lecture 355Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 356Medication Guide - Review Checklist | Inspection Checklist
Lecture 357PI Vs. Medication Guide Comparison
Lecture 358Patient Information Leaflet (PIL) vs Medication Guide
Lecture 359Label Components | Key considerations for effective designing of label
Lecture 360Label Review Checklist
Lecture 361Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 362Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 363Instruction for Use (IFU) | Design and Development of IFU
Lecture 364UDI | Different Component | How to design
Lecture 365Implant Card | Regulatory Importance | Content | How to design
Lecture 366Color Proofing, Dielines & Version Control"
Lecture 367CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 368Injection Labels - Labels and Cartons
Lecture 369Various Design Component Placement Understanding (Injectables)
Lecture 370Concept of Logo File | Open and Curve File Importance
Lecture 371QC and Proof Reading in Labelling and Artwork
Lecture 372QC and Proofreading Checklist
Lecture 373Template Management and Creative Brief
Lecture 374Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 375Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 376Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 377Bulk Pack Labelling
Lecture 378Bulk Pack Labelling Checklist
Lecture 379OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 380OTC vs Prescription (Rx) Label Checklist
Lecture 381OTC Approval Matrix
Lecture 382OTC Claim Risk Scoring System
Section 21CCDS Management Training for Medical Affairs Professionals
Lecture 383CCDS Management
Lecture 384CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 385AI Augmented Labelling Compliance System
Lecture 386Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 387AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 388CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 389CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 390Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 391Case Study on Centralized Artwork Operation [Recall Management]
Lecture 392Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 393Source Documents | Artwork Brief
Lecture 394Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies
Lecture 395Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes
Lecture 396Label Impact Assessment Checklist
Lecture 397Packaging Types & Their Impact on Artwork
Lecture 398Design tool used in artwork | Esko Platform | Adobe Illustrator | CorelDRAW | File Format | Label Design Workflow and Tool Utilization
Lecture 399Labelling 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 400Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 401RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 402RWD and RWE in Product Lifecycle Management
Lecture 403RWD and RWE - Fit to use | Assessment
Lecture 404RWD data sources | Different types | Detailed understanding of each class
Lecture 405RWD Study Design
Lecture 406RWE Published Tool | Insights on commonly used tools
Lecture 407Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 408Consensus Narrative Review
Lecture 409Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 410Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 411RWD Characteristics
Lecture 412RCT vs. RWE Comparison | Case Based Analysis
Lecture 413RCT and RWE Comparison
Lecture 414Introduction to Healthcare Datasets
Lecture 415Dataset 1: Claims Data (Insurance)
Lecture 416Dataset 2: Retail Pharmacy Prescription Data
Lecture 417Dataset 3: Longitudinal Patient Data
Lecture 418Characteristics of Different Set of Healthcare Data
Lecture 419Reimbursement and Pricing Datasets
Lecture 420RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 421Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 422RWD & RWE Case Database
Lecture 423RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 23AI Tools, Ethics and Future Landscape
Lecture 424AI Reg Tools - Review | Understanding Capabilities
Lecture 425Regulatory Authority View on AI Adoption
Lecture 426Data Sensitivity | Levels | Consequences | Management
Lecture 427Governance Flowchart – AI Tools in GxP Environments
Lecture 428Generalist Vs. Specialist AI Tools
Lecture 429AI Generalist Overview (Life Science Focus)
Lecture 430Horizontal vs Vertical AI Tools
Lecture 431AI Tool Assessment Test
Lecture 432Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 24Prompt Engineering in Medical Affairs
Lecture 433Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 434Special Prompting Structure - Case Based Prompt Designing
Lecture 435Special Prompting Structure - Case Based Prompt Designing
Lecture 436PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 437PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 438How to adjust the parameters | Techniques
Lecture 439Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
