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)
Section 2Discovery Development | R&D Management | US Regulations
Lecture 17R&D Process & Introduction to drug discovery
Lecture 18Investigational New Drug Application (INDA)
Lecture 19New Drug Application (NDA)
Lecture 20Basic concept and understanding of the Generic Drug
Lecture 21Abbreviated New Drug Application (ANDA)
Lecture 22Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 23Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 24Purple Book: Significance | Searching | Assignments
Lecture 25Handling of orange book
Lecture 26USFDA expedited programs
Lecture 27Preformulation Study in Drug Development
Lecture 28Regulatory Requirements for Preformulation Study
Lecture 29Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 30Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 31Types and Timing of Non-clinical Studies
Lecture 32Exploratory IND Vs. Traditional IND
Lecture 33Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 34Orphan Drug Designation
Lecture 35Review on Drug Discovery and Development
Lecture 36Understanding on Clinical Trials and Clinical Research
Lecture 37Clinical Trial Protocol Writing
Lecture 38Ethics in Clinical Research
Lecture 39Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 40FDA Forms and How to fill the resources
Lecture 41Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 42Chemistry, Manufacturing & Controls
Lecture 43Fundamental 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 44505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 45Advance Learning on 505B2 Pathway
Lecture 46Authorized Generics: Key Understanding
Lecture 47Complete Response Letter | Key understanding | Management and Action Plan
Lecture 48Introduction to ICH | Members | Guidelines
Lecture 49ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 50ICH Q2 : Analytical Validation
Lecture 51ICH Q3 : Impurities
Lecture 52Rest of ICH Q Family Guidelines
Lecture 53Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Section 3EU Regulation and Authorization Planning
Lecture 54EU Regulatory System Fundamentals
Lecture 55Introduction to EU Regulation
Lecture 56Orientation to European Countries and National Regulatory Bodies
Lecture 57EMA and EMA Authorisation Process
Lecture 58Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 59EU MA Application Types and Strategic Planning
Lecture 60EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 61EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 62Validity 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 63Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 64Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 65Centralised Procedure Timetable and Review Logic
Lecture 66DCP / MRP / National Procedure – Practical Workflow Module
Lecture 67EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 68DCP vs MRP Timeline
Lecture 69EU Adaptive Pathway
Lecture 70European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 71SPOR - Concept of Master Data Management
Lecture 72The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 73LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 74Response to list of Questions (LoQ)
Lecture 75Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 76Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 77CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 78Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 79Compassionate Use
Lecture 80EU Prime Designation
Lecture 81MHRA - UK Regulation
Lecture 82Summary of Product Characteristics
Lecture 83Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 84Accelerated assessment by EMEA
Lecture 85Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 86Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Section 4Portfolio Strategic Management
Lecture 87Regulatory Strategies in different phases of Clinical Trial
Lecture 88Para IV Filing - Strategic Insight
Lecture 89Para IV Notices
Lecture 90Evergreening - Patent Life Extension Strategies
Lecture 91Pay For Delay Strategy
Lecture 92REMS Strategic Planning
Lecture 93Compulsory Licensing
Lecture 94Licensing & Technology Transfer
Lecture 95In-Licensing Vs. Outlicensing
Lecture 96LOE Strategies for Innovator Brands with case study
Lecture 97Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 98Drug Repurposing
Lecture 99Advance understanding of the portfolio Management
Lecture 100New Indication Approval Process and Promotion
Lecture 101OTC Switch
Lecture 102Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 103NCE Vs. 505b2 application - Case Based Learning
Lecture 104FTF - 180 Days Exclusivity - Case Based Learning
Lecture 105Classic case study of the 505b2 filing : Case Based Learning
Lecture 106Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 107What is meaning of 'Pipeline in a Molecule'?
Lecture 108USFDA Emergency Use Authorization (EUA)
Lecture 109Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 110Fundamental 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 111Review on Drug Discovery and Development
Section 5Bioequivalence Study : Requirements
Lecture 112PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 113Bioequivalence Study | Study design | Different types of BE Studies
Lecture 114Bioequivalence 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 115Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 116Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 117Bioequivalence Study - Discussion - Dissolution Testing
Lecture 118Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 6Pharmacoeconomics | HEOR
Lecture 119Introduction to Health Economics | Key terminologies related to health economics.
Lecture 120HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 121Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 122Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 123Core 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 124Pharmacoeconomic 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 125Pharmacoeconomic 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 126Pharmacoeconomic 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 127Patient Based Forecasting Model | Applying more filters and variables
Lecture 128QALY | How to calculate QALY | Importance and Significance
Lecture 129ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 130CER and PCOR
Section 7Market Access of Pharma and Biologics
Lecture 131Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 132Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 133Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 134Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 135Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 136AMCP Market Access Dossier Preparation
Lecture 137Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 138Pharma Market Access Pricing Case Study: interchangeable Pricing
Section 8Pharma Forecasting
Lecture 139Sales Forecasting in Life Science Industry
Lecture 140New Product Forecast Algorithm
Lecture 141Patient Based Forecasting Model | Applying more filters and variables
Lecture 142Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 143Prevalence Vs. Incidence Model
Lecture 144EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 145Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 146Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 147Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 148Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 149Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 150Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 151Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 152Simulation on Bottom-up forecasting
Lecture 153Assessment on Bottom-up forecasting
Lecture 154Oncology Brand Forecasting
Lecture 155Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 156Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 157First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 158Forecasting Biosimilar | Key Factors to consider
Lecture 159Consensus Meeting
Lecture 160One Number Vs. Multi Number Forecasting
Lecture 161Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 162Treatment Algorithm and Forecasting : Case Based Learning
Lecture 163Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 164Prescription Value Calculation
Section 9Pricing and Reimbursements
Lecture 165Drug Pricing Methodologies
Lecture 166Drug Pricing Methodologies - II
Lecture 167Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 168Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 169Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 170Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 10Evidence Generation | Real World Data | Real World Evidence
Lecture 171Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 172RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 173RWD and RWE in Product Lifecycle Management
Lecture 174RWD and RWE - Fit to use | Assessment
Lecture 175RWD data sources | Different types | Detailed understanding of each class
Section 11Pharma Digital Marketing
Lecture 176Introduction to Digital Marketing
Lecture 177Inbound and outbound marketing in pharma | Types of inbound and outbound marketing
Lecture 178Digital 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 179Digital 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 180Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 181Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 182Campaign 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 183Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 184Web Host - Check the hosting details
Lecture 185Page Speed- importance and practical understanding | Check the web speed
Lecture 186Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 187Mobile Responsive | Tracking the Site
Lecture 188HCP sites and Patient Site
Lecture 189Google Ad - Practical Training on Campaign Development and Execution
Lecture 190Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 191Brand Portal Development
Lecture 192Relationship Marketing : KOL Management and Patient Advocacy Group
Lecture 193Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 194Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 195Difference between FMCG and OTC Brand Ad
Lecture 196Digital Marketing Techniques
Lecture 197Video Marketing
Lecture 198Video Marketing Techniques For Small Business Owners
Lecture 199Promoting Brand through Article Advertising and Marketing
Section 12Lead Generation | Management | Deal Structuring | Implementation
Lecture 200Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 201Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 202Compound Annual Growth Rate | CAGR Calculation
Lecture 203Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 204Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 205Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 206Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 207Numerical SWOT Practical training
Lecture 208Modelling 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 209Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 210Forecasting : Tools and Techniques
Lecture 211Market Sizing & Forecasting Case Study
Lecture 212Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 213Average Royalty Rate
Lecture 214Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 215Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 216Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 217Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 218SPECIAL PURPOSE VEHICLES (SPV)
Lecture 219Indication Splitting | Concept | Implementation feasibility analysis
Lecture 220Types of Deals from Discovery to Commercialization
Lecture 221What are the fundamental areas of business development
Lecture 222Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 223Licensing Payment Scheduling: Different Types
Lecture 224Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 225Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 226Negotiation 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 227Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 228Types 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 229Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Section 13Drug Safety | Pharmacovigilance
Lecture 230Introduction to Pharmacovigilance
Lecture 231Adverse Drug Reactions
Lecture 232ADR: Pharmacology
Lecture 233ADR: Classification
Lecture 234PV and ADR Monitoring
Lecture 235ADR and Related Terminologies
Lecture 236ADR Reporting System
Lecture 237DoTS
Lecture 2384 Elements of AEs
Lecture 239ADR Reporting Limitations
Lecture 240ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 241The Adverse Drug Reaction (ADR) Probability Scale
Lecture 242Pharmacovigilance Process
Lecture 243PSURs
Lecture 244Risk Management
Section 14Regulatory Submission Management | Regulatory CMC Writing
Lecture 245Common Technical Document (CTD)
Lecture 246CMC Dossier & Compliance Management
Lecture 247Electronic Common Technical Document (ECTD)
Lecture 248Key Consideration for Drug Master File Preparation and Submission
Lecture 249Practical Understanding on Drug Master File Preparation and Submission
Lecture 250Site Master File - Detailed Understanding
Lecture 251Importance of effective dossier management
Lecture 252Discussion on 85 common deficiencies in CTD submission dossier
Lecture 253Detailed Understanding on ANDA Submission Dossier
Section 15Preparing Clinical Study Report
Lecture 254How to prepare and write clinical study report
Lecture 255Example of Clinical Study Report : new medication for treating hypertension
Lecture 256Compare Clinical Study Report of 2 comparing medication
Lecture 257How to interpret clinical study report
Lecture 258Understanding RCT
Lecture 259Understanding Blinding
Lecture 260Publishing Clinical Study Reports
Section 16AI in Medical Affairs and Medical Writing
Lecture 261Introduction to AI
Lecture 262Basics of AI ML DL | Key Differences | Application in industry
Lecture 263Types of AI
Lecture 264AI Project | Overview
Lecture 265Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 266How machine learning
Lecture 267Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 268Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 269AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 270AI Terms with Regulatory Significance | Regulatory Applications
Lecture 271NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 272Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 273Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 274AI Data Quality Standard | Checklist
Lecture 275Download AI Data Quality Checklist
Lecture 276Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 277AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 278AI Technologies in RA
Lecture 279Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 280Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 17AI in Regulatory Authoring and CMC Writing
Lecture 281AI in Regulatory Authoring and CMC Writing
Lecture 282AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 283Tips for Selecting AI Tools (CMC Authoring)
Lecture 284CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 285HITL Regulatory Document Authoring
Lecture 286Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 287Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 18Publishing and Advanced eCTD v4.0 Training
Lecture 288eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 289eCTDV4.0 Structure | Lifecycle Management
Lecture 290eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 291eCTD Validation Tools
Lecture 292eCTD Publishing Cycle
Lecture 293HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 294Tips and Submission Readiness Checklist
Lecture 295eCTD Submission Checklist Format
Lecture 296Regulatory Publishing Document Control Challenges
Lecture 297Document Control Checklist
Lecture 298Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 299Formatting Rules Templated and Agency Specification
Lecture 300Versioning for Regulatory Publishing
Lecture 301File Naming Standard
Lecture 302Text Recognition and Optical Character Recognition (OCR)
Lecture 303Versioning File Naming OCR - How they work together
Lecture 304Final Document Assembly
Lecture 305Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 306TOC and CI Management
Lecture 307Initial Submission & Maintenance Submission
Lecture 308Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 309eCTD Dossier Lifecycle - Multi Sequence View
Lecture 31010 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 311Global Decision Tree - Classifying Post Approval Changes
Lecture 312eCTD Technical Validation | Typical issues | Resolutions
Lecture 313eCTD Validation Readiness Checklist
Lecture 314QC Checklist Design and Pre Submission Review
Lecture 315Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 316Regulatory Publishing Simulation
Lecture 317Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 19Data Integrity issues in Medical Writing : Detailed Understanding
Lecture 318Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 319Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 320Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 321RTQs | Response to Queries | How to handle Regulatory Queries
Lecture 322AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 323Cases of data breaches with explanation
Lecture 324Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 20Labelling and Artwork Management in Medical Affairs
Lecture 325Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 326Types of Labels
Lecture 327Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 328Global Artwork Labelling Framework | 5 Case Simulation
Lecture 329Country-Specific Labelling Requirements
Lecture 330Summary of Product Characteristics (SmPC)
Lecture 331Patient Information Leaflet (PIL)
Lecture 332Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 333Patient Information Leaflet (PIL) – Review Checklist
Lecture 334US Prescribing Information (PI) | Differences with EU SmPC
Lecture 335US Prescribing Information (PI) - Review Checklist
Lecture 336Fundamental Understanding on Medication Guide
Lecture 337Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 338Medication Guide - Review Checklist | Inspection Checklist
Lecture 339PI Vs. Medication Guide Comparison
Lecture 340Patient Information Leaflet (PIL) vs Medication Guide
Lecture 341Label Components | Key considerations for effective designing of label
Lecture 342Label Review Checklist
Lecture 343Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 344Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 345Instruction for Use (IFU) | Design and Development of IFU
Lecture 346UDI | Different Component | How to design
Lecture 347Implant Card | Regulatory Importance | Content | How to design
Lecture 348Color Proofing, Dielines & Version Control"
Lecture 349CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 350Injection Labels - Labels and Cartons
Lecture 351Various Design Component Placement Understanding (Injectables)
Lecture 352Concept of Logo File | Open and Curve File Importance
Lecture 353QC and Proof Reading in Labelling and Artwork
Lecture 354QC and Proofreading Checklist
Lecture 355Template Management and Creative Brief
Lecture 356Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 357Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 358Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 359Bulk Pack Labelling
Lecture 360Bulk Pack Labelling Checklist
Lecture 361OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 362OTC vs Prescription (Rx) Label Checklist
Lecture 363OTC Approval Matrix
Lecture 364OTC Claim Risk Scoring System
Section 21CCDS Management Training for Medical Affairs Professionals
Lecture 365CCDS Management
Lecture 366CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 367AI Augmented Labelling Compliance System
Lecture 368Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 369AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 370CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 371CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 372Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 373Case Study on Centralized Artwork Operation [Recall Management]
Lecture 374Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 375Source Documents | Artwork Brief
Lecture 376Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies
Lecture 377Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes
Lecture 378Label Impact Assessment Checklist
Lecture 379Packaging Types & Their Impact on Artwork
Lecture 380Design tool used in artwork | Esko Platform | Adobe Illustrator | CorelDRAW | File Format | Label Design Workflow and Tool Utilization
Lecture 381Labelling 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 382Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 383RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 384RWD and RWE in Product Lifecycle Management
Lecture 385RWD and RWE - Fit to use | Assessment
Lecture 386RWD data sources | Different types | Detailed understanding of each class
Lecture 387RWD Study Design
Lecture 388RWE Published Tool | Insights on commonly used tools
Lecture 389Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 390Consensus Narrative Review
Lecture 391Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 392Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 393RWD Characteristics
Lecture 394RCT vs. RWE Comparison | Case Based Analysis
Lecture 395RCT and RWE Comparison
Lecture 396Introduction to Healthcare Datasets
Lecture 397Dataset 1: Claims Data (Insurance)
Lecture 398Dataset 2: Retail Pharmacy Prescription Data
Lecture 399Dataset 3: Longitudinal Patient Data
Lecture 400Characteristics of Different Set of Healthcare Data
Lecture 401Reimbursement and Pricing Datasets
Lecture 402RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 403Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 404RWD & RWE Case Database
Lecture 405RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 23AI Tools, Ethics and Future Landscape
Lecture 406AI Reg Tools - Review | Understanding Capabilities
Lecture 407Regulatory Authority View on AI Adoption
Lecture 408Data Sensitivity | Levels | Consequences | Management
Lecture 409Governance Flowchart – AI Tools in GxP Environments
Lecture 410Generalist Vs. Specialist AI Tools
Lecture 411AI Generalist Overview (Life Science Focus)
Lecture 412Horizontal vs Vertical AI Tools
Lecture 413AI Tool Assessment Test
Lecture 414Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 24Prompt Engineering in Medical Affairs
Lecture 415Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 416Special Prompting Structure - Case Based Prompt Designing
Lecture 417Special Prompting Structure - Case Based Prompt Designing
Lecture 418PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 419PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 420How to adjust the parameters | Techniques
Lecture 421Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
