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
Lecture 35Architecture of CSR
Lecture 36CSR Writing - Recap and Key Insights
Section 2Discovery Development | R&D Management | US Regulations
Lecture 37R&D Process & Introduction to drug discovery
Lecture 38Investigational New Drug Application (INDA)
Lecture 39New Drug Application (NDA)
Lecture 40Basic concept and understanding of the Generic Drug
Lecture 41Abbreviated New Drug Application (ANDA)
Lecture 42Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 43Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 44Purple Book: Significance | Searching | Assignments
Lecture 45Handling of orange book
Lecture 46USFDA expedited programs
Lecture 47Preformulation Study in Drug Development
Lecture 48Regulatory Requirements for Preformulation Study
Lecture 49Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 50Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 51Types and Timing of Non-clinical Studies
Lecture 52Exploratory IND Vs. Traditional IND
Lecture 53Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 54Orphan Drug Designation
Lecture 55Review on Drug Discovery and Development
Lecture 56Understanding on Clinical Trials and Clinical Research
Lecture 57Clinical Trial Protocol Writing
Lecture 58Ethics in Clinical Research
Lecture 59Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 60FDA Forms and How to fill the resources
Lecture 61Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 62Chemistry, Manufacturing & Controls
Lecture 63Fundamental 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 64505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 65Advance Learning on 505B2 Pathway
Lecture 66Authorized Generics: Key Understanding
Lecture 67Complete Response Letter | Key understanding | Management and Action Plan
Lecture 68Introduction to ICH | Members | Guidelines
Lecture 69ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 70ICH Q2 : Analytical Validation
Lecture 71ICH Q3 : Impurities
Lecture 72Rest of ICH Q Family Guidelines
Lecture 73Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Section 3EU Regulation and Authorization Planning
Lecture 74EU Regulatory System Fundamentals
Lecture 75Introduction to EU Regulation
Lecture 76Orientation to European Countries and National Regulatory Bodies
Lecture 77EMA and EMA Authorisation Process
Lecture 78Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 79EU MA Application Types and Strategic Planning
Lecture 80EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 81EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 82Validity 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 83Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 84Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 85Centralised Procedure Timetable and Review Logic
Lecture 86DCP / MRP / National Procedure – Practical Workflow Module
Lecture 87EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 88DCP vs MRP Timeline
Lecture 89EU Adaptive Pathway
Lecture 90European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 91SPOR - Concept of Master Data Management
Lecture 92The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 93LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 94Response to list of Questions (LoQ)
Lecture 95Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 96Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 97CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 98Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 99Compassionate Use
Lecture 100EU Prime Designation
Lecture 101MHRA - UK Regulation
Lecture 102Summary of Product Characteristics
Lecture 103Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 104Accelerated assessment by EMEA
Lecture 105Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 106Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Section 4Portfolio Strategic Management
Lecture 107Regulatory Strategies in different phases of Clinical Trial
Lecture 108Para IV Filing - Strategic Insight
Lecture 109Para IV Notices
Lecture 110Evergreening - Patent Life Extension Strategies
Lecture 111Pay For Delay Strategy
Lecture 112REMS Strategic Planning
Lecture 113Compulsory Licensing
Lecture 114Licensing & Technology Transfer
Lecture 115In-Licensing Vs. Outlicensing
Lecture 116LOE Strategies for Innovator Brands with case study
Lecture 117Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 118Drug Repurposing
Lecture 119Advance understanding of the portfolio Management
Lecture 120New Indication Approval Process and Promotion
Lecture 121OTC Switch
Lecture 122Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 123NCE Vs. 505b2 application - Case Based Learning
Lecture 124FTF - 180 Days Exclusivity - Case Based Learning
Lecture 125Classic case study of the 505b2 filing : Case Based Learning
Lecture 126Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 127What is meaning of 'Pipeline in a Molecule'?
Lecture 128USFDA Emergency Use Authorization (EUA)
Lecture 129Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 130Fundamental 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 131Review on Drug Discovery and Development
Section 5Bioequivalence Study : Requirements
Lecture 132PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 133Bioequivalence Study | Study design | Different types of BE Studies
Lecture 134Bioequivalence 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 135Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 136Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 137Bioequivalence Study - Discussion - Dissolution Testing
Lecture 138Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 6Pharmacoeconomics | HEOR
Lecture 139Introduction to Health Economics | Key terminologies related to health economics.
Lecture 140HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 141Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 142Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 143Core 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 144Pharmacoeconomic 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 145Pharmacoeconomic 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 146Pharmacoeconomic 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 147Patient Based Forecasting Model | Applying more filters and variables
Lecture 148QALY | How to calculate QALY | Importance and Significance
Lecture 149ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 150CER and PCOR
Section 7Market Access of Pharma and Biologics
Lecture 151Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 152Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 153Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 154Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 155Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 156AMCP Market Access Dossier Preparation
Lecture 157Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 158Pharma Market Access Pricing Case Study: interchangeable Pricing
Section 8Pharma Forecasting
Lecture 159Sales Forecasting in Life Science Industry
Lecture 160New Product Forecast Algorithm
Lecture 161Patient Based Forecasting Model | Applying more filters and variables
Lecture 162Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 163Prevalence Vs. Incidence Model
Lecture 164EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 165Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 166Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 167Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 168Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 169Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 170Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 171Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 172Simulation on Bottom-up forecasting
Lecture 173Assessment on Bottom-up forecasting
Lecture 174Oncology Brand Forecasting
Lecture 175Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 176Portfolio Based Forecasting | Forecasting Model Development in Excel
Lecture 177First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 178Forecasting Biosimilar | Key Factors to consider
Lecture 179Consensus Meeting
Lecture 180One Number Vs. Multi Number Forecasting
Lecture 181Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 182Treatment Algorithm and Forecasting : Case Based Learning
Lecture 183Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 184Prescription Value Calculation
Section 9Pricing and Reimbursements
Lecture 185Drug Pricing Methodologies
Lecture 186Drug Pricing Methodologies - II
Lecture 187Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 188Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 189Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 190Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 10Evidence Generation | Real World Data | Real World Evidence
Lecture 191Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 192RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 193RWD and RWE in Product Lifecycle Management
Lecture 194RWD and RWE - Fit to use | Assessment
Lecture 195RWD data sources | Different types | Detailed understanding of each class
Section 11Pharma Digital Marketing
Lecture 196Introduction to Digital Marketing
Lecture 197Inbound and outbound marketing in pharma | Types of inbound and outbound marketing
Lecture 198Digital 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 199Digital 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 200Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 201Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 202Campaign 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 203Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 204Web Host - Check the hosting details
Lecture 205Page Speed- importance and practical understanding | Check the web speed
Lecture 206Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 207Mobile Responsive | Tracking the Site
Lecture 208HCP sites and Patient Site
Lecture 209Google Ad - Practical Training on Campaign Development and Execution
Lecture 210Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 211Brand Portal Development
Lecture 212Relationship Marketing : KOL Management and Patient Advocacy Group
Lecture 213Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 214Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 215Difference between FMCG and OTC Brand Ad
Lecture 216Digital Marketing Techniques
Lecture 217Video Marketing
Lecture 218Video Marketing Techniques For Small Business Owners
Lecture 219Promoting Brand through Article Advertising and Marketing
Section 12Lead Generation | Management | Deal Structuring | Implementation
Lecture 220Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 221Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 222Compound Annual Growth Rate | CAGR Calculation
Lecture 223Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 224Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 225Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 226Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 227Numerical SWOT Practical training
Lecture 228Modelling 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 229Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 230Forecasting : Tools and Techniques
Lecture 231Market Sizing & Forecasting Case Study
Lecture 232Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 233Average Royalty Rate
Lecture 234Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 235Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 236Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 237Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 238SPECIAL PURPOSE VEHICLES (SPV)
Lecture 239Indication Splitting | Concept | Implementation feasibility analysis
Lecture 240Types of Deals from Discovery to Commercialization
Lecture 241What are the fundamental areas of business development
Lecture 242Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 243Licensing Payment Scheduling: Different Types
Lecture 244Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 245Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 246Negotiation 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 247Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 248Types 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 249Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Section 13Drug Safety | Pharmacovigilance
Lecture 250Introduction to Pharmacovigilance
Lecture 251Adverse Drug Reactions
Lecture 252ADR: Pharmacology
Lecture 253ADR: Classification
Lecture 254PV and ADR Monitoring
Lecture 255ADR and Related Terminologies
Lecture 256ADR Reporting System
Lecture 257DoTS
Lecture 2584 Elements of AEs
Lecture 259ADR Reporting Limitations
Lecture 260ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 261The Adverse Drug Reaction (ADR) Probability Scale
Lecture 262Pharmacovigilance Process
Lecture 263PSURs
Lecture 264Risk Management
Section 14Regulatory Submission Management | Regulatory CMC Writing
Lecture 265Common Technical Document (CTD)
Lecture 266CMC Dossier & Compliance Management
Lecture 267Electronic Common Technical Document (ECTD)
Lecture 268Key Consideration for Drug Master File Preparation and Submission
Lecture 269Practical Understanding on Drug Master File Preparation and Submission
Lecture 270Site Master File - Detailed Understanding
Lecture 271Importance of effective dossier management
Lecture 272Discussion on 85 common deficiencies in CTD submission dossier
Lecture 273Detailed Understanding on ANDA Submission Dossier
Section 15Preparing Clinical Study Report
Lecture 274How to prepare and write clinical study report
Lecture 275Example of Clinical Study Report : new medication for treating hypertension
Lecture 276Compare Clinical Study Report of 2 comparing medication
Lecture 277How to interpret clinical study report
Lecture 278Understanding RCT
Lecture 279Understanding Blinding
Lecture 280Publishing Clinical Study Reports
Section 16AI in Medical Affairs and Medical Writing
Lecture 281Introduction to AI
Lecture 282Basics of AI ML DL | Key Differences | Application in industry
Lecture 283Types of AI
Lecture 284AI Project | Overview
Lecture 285Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 286How machine learning
Lecture 287Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 288Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 289AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 290AI Terms with Regulatory Significance | Regulatory Applications
Lecture 291NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 292Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 293Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 294AI Data Quality Standard | Checklist
Lecture 295Download AI Data Quality Checklist
Lecture 296Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 297AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 298AI Technologies in RA
Lecture 299Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 300Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 17AI in Regulatory Authoring and CMC Writing
Lecture 301AI in Regulatory Authoring and CMC Writing
Lecture 302AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 303Tips for Selecting AI Tools (CMC Authoring)
Lecture 304CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 305HITL Regulatory Document Authoring
Lecture 306Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 307Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 18Publishing and Advanced eCTD v4.0 Training
Lecture 308eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 309eCTDV4.0 Structure | Lifecycle Management
Lecture 310eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 311eCTD Validation Tools
Lecture 312eCTD Publishing Cycle
Lecture 313HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 314Tips and Submission Readiness Checklist
Lecture 315eCTD Submission Checklist Format
Lecture 316Regulatory Publishing Document Control Challenges
Lecture 317Document Control Checklist
Lecture 318Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 319Formatting Rules Templated and Agency Specification
Lecture 320Versioning for Regulatory Publishing
Lecture 321File Naming Standard
Lecture 322Text Recognition and Optical Character Recognition (OCR)
Lecture 323Versioning File Naming OCR - How they work together
Lecture 324Final Document Assembly
Lecture 325Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 326TOC and CI Management
Lecture 327Initial Submission & Maintenance Submission
Lecture 328Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 329eCTD Dossier Lifecycle - Multi Sequence View
Lecture 33010 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 331Global Decision Tree - Classifying Post Approval Changes
Lecture 332eCTD Technical Validation | Typical issues | Resolutions
Lecture 333eCTD Validation Readiness Checklist
Lecture 334QC Checklist Design and Pre Submission Review
Lecture 335Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 336Regulatory Publishing Simulation
Lecture 337Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 19Data Integrity issues in Medical Writing : Detailed Understanding
Lecture 338Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 339Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 340Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 341RTQs | Response to Queries | How to handle Regulatory Queries
Lecture 342AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 343Cases of data breaches with explanation
Lecture 344Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 20Labelling and Artwork Management in Medical Affairs
Lecture 345Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 346Types of Labels
Lecture 347Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 348Global Artwork Labelling Framework | 5 Case Simulation
Lecture 349Country-Specific Labelling Requirements
Lecture 350Summary of Product Characteristics (SmPC)
Lecture 351Patient Information Leaflet (PIL)
Lecture 352Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 353Patient Information Leaflet (PIL) – Review Checklist
Lecture 354US Prescribing Information (PI) | Differences with EU SmPC
Lecture 355US Prescribing Information (PI) - Review Checklist
Lecture 356Fundamental Understanding on Medication Guide
Lecture 357Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 358Medication Guide - Review Checklist | Inspection Checklist
Lecture 359PI Vs. Medication Guide Comparison
Lecture 360Patient Information Leaflet (PIL) vs Medication Guide
Lecture 361Label Components | Key considerations for effective designing of label
Lecture 362Label Review Checklist
Lecture 363Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 364Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 365Instruction for Use (IFU) | Design and Development of IFU
Lecture 366UDI | Different Component | How to design
Lecture 367Implant Card | Regulatory Importance | Content | How to design
Lecture 368Color Proofing, Dielines & Version Control"
Lecture 369CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 370Injection Labels - Labels and Cartons
Lecture 371Various Design Component Placement Understanding (Injectables)
Lecture 372Concept of Logo File | Open and Curve File Importance
Lecture 373QC and Proof Reading in Labelling and Artwork
Lecture 374QC and Proofreading Checklist
Lecture 375Template Management and Creative Brief
Lecture 376Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 377Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 378Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 379Bulk Pack Labelling
Lecture 380Bulk Pack Labelling Checklist
Lecture 381OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 382OTC vs Prescription (Rx) Label Checklist
Lecture 383OTC Approval Matrix
Lecture 384OTC Claim Risk Scoring System
Section 21CCDS Management Training for Medical Affairs Professionals
Lecture 385CCDS Management
Lecture 386CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 387AI Augmented Labelling Compliance System
Lecture 388Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 389AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 390CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 391CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 392Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 393Case Study on Centralized Artwork Operation [Recall Management]
Lecture 394Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 395Source Documents | Artwork Brief
Lecture 396Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies
Lecture 397Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes
Lecture 398Label Impact Assessment Checklist
Lecture 399Packaging Types & Their Impact on Artwork
Lecture 400Design tool used in artwork | Esko Platform | Adobe Illustrator | CorelDRAW | File Format | Label Design Workflow and Tool Utilization
Lecture 401Labelling 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 402Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 403RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 404RWD and RWE in Product Lifecycle Management
Lecture 405RWD and RWE - Fit to use | Assessment
Lecture 406RWD data sources | Different types | Detailed understanding of each class
Lecture 407RWD Study Design
Lecture 408RWE Published Tool | Insights on commonly used tools
Lecture 409Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 410Consensus Narrative Review
Lecture 411Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 412Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 413RWD Characteristics
Lecture 414RCT vs. RWE Comparison | Case Based Analysis
Lecture 415RCT and RWE Comparison
Lecture 416Introduction to Healthcare Datasets
Lecture 417Dataset 1: Claims Data (Insurance)
Lecture 418Dataset 2: Retail Pharmacy Prescription Data
Lecture 419Dataset 3: Longitudinal Patient Data
Lecture 420Characteristics of Different Set of Healthcare Data
Lecture 421Reimbursement and Pricing Datasets
Lecture 422RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 423Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 424RWD & RWE Case Database
Lecture 425RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 23AI Tools, Ethics and Future Landscape
Lecture 426AI Reg Tools - Review | Understanding Capabilities
Lecture 427Regulatory Authority View on AI Adoption
Lecture 428Data Sensitivity | Levels | Consequences | Management
Lecture 429Governance Flowchart – AI Tools in GxP Environments
Lecture 430Generalist Vs. Specialist AI Tools
Lecture 431AI Generalist Overview (Life Science Focus)
Lecture 432Horizontal vs Vertical AI Tools
Lecture 433AI Tool Assessment Test
Lecture 434Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 24Prompt Engineering in Medical Affairs
Lecture 435Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 436Special Prompting Structure - Case Based Prompt Designing
Lecture 437Special Prompting Structure - Case Based Prompt Designing
Lecture 438PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 439PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 440How to adjust the parameters | Techniques
Lecture 441Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
