InstructorRoyed Training
TypeOnline Course
Price$770 / 38500 INR.
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medical affairs training course

Introduction

Features

Related Courses

About Pharma Management

medical affairs course by royed training

In the dynamic and ever-evolving landscape of healthcare, staying at the forefront of medical knowledge and industry trends is paramount. Recognizing the pivotal role played by Medical Affairs professionals in bridging the gap between science and business, we, at Royed Training, are proud to introduce “All Skilled in One” comprehensive Medical Affairs Training Program.

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.

Benefits of Medical Affairs Course

  • Enhanced expertise in medical science and regulatory affairs
  • Improved strategic thinking and decision-making skills
  • Networking opportunities with industry leaders
  • Practical skills application through hands-on training
  • Continuous professional development in a rapidly evolving field

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.

Career in Medical Affairs

Medical Affairs is a critical function within the pharmaceutical, biotechnology, and medical device industries. It is responsible for communicating accurate and unbiased information about a company’s products and services to healthcare professionals, regulators, and patients. Medical Affairs professionals 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?

Medical affairs and medical writing are closely related fields, but they have distinct roles and responsibilities. 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.

Medical affairs professionals 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

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

Medical writers typically work under the direction of medical affairs professionals. They may also work with other professionals, such as scientists, engineers, and regulatory experts.

Section 1Fundamental of Medical Affairs | Dynamics | Functional Roles
Lecture 1Introduction to Medical Affairs
Lecture 2Detailed understanding on Medical Affairs Functions
Lecture 3Medical Affairs Engagement in Pharma and Biopharma Strategic Management
Lecture 4Customer Centric Mindset in Medical Affairs
Lecture 5Medical affairs paradigm
Lecture 6Medical Affairs in Drug Discovery to Commercialization Phases
Lecture 7Evolving Medical Affairs capabilities
Lecture 8Medical Affairs - Key Activities
Lecture 9Job Role - Medical Advisor
Lecture 10Job Role - MSL - Role and Responsibilities
Section 2Discovery Development | R&D Management | Regulations
Lecture 11R&D Process & Introduction to drug discovery
Lecture 12Investigational New Drug Application (INDA)
Lecture 13New Drug Application (NDA) 
Lecture 14Basic concept and understanding of the Generic Drug
Lecture 15Abbreviated New Drug Application (ANDA) 
Lecture 16Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 17Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 18Purple Book: Significance | Searching | Assignments
Lecture 19Handling of orange book
Lecture 20USFDA expedited programs
Lecture 21Practical Training on INDA, NDA, ANDA filing
Lecture 22505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 23Authorized Generics: Key Understanding
Lecture 24Exploratory IND Vs. Traditional IND
Lecture 25Patents Vs. exclusivity 
Lecture 26Orphan Drug Designation 
Lecture 27Advance Learning on 505B2 Pathway
Lecture 28Chemistry, Manufacturing & Controls 
Lecture 29Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 30Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 31Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 32Drug Repurposing
Lecture 33Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 34NCE Vs. 505b2 application - Case Based Learning 
Lecture 35FTF - 180 Days Exclusivity - Case Based Learning
Lecture 36Classic case study of the 505b2 filing : Case Based Learning
Lecture 37What is meaning of 'Pipeline in a Molecule'?
Lecture 38USFDA Emergency Use Authorization (EUA)
Lecture 39Fundamental 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 40Review on Drug Discovery and Development 
Section 3Non-clinical and Clinical Development
Lecture 41Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 42Clinical Trial Protocol Writing
Lecture 43Ethics in Clinical Research
Lecture 44Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 45FDA Forms and How to fill the resources
Lecture 46Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 47Importance and Significance of Phase 2b Clinical Trial 
Section 4Portfolio Strategic Management
Lecture 48Regulatory Strategies in different phases of Clinical Trial
Lecture 49Para IV Filing - Strategic Insight
Lecture 50Para IV Notices
Lecture 51Evergreening - Patent Life Extension Strategies
Lecture 52Pay For Delay Strategy
Lecture 53REMS Strategic Planning 
Lecture 54Compulsory Licensing
Lecture 55Licensing & Technology Transfer
Lecture 56In-Licensing Vs. Outlicensing
Lecture 57LOE Strategies for Innovator Brands with case study
Lecture 58Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 59Drug Repurposing
Lecture 60Advance understanding of the portfolio Management 
Lecture 61New Indication Approval Process and Promotion 
Lecture 62OTC Switch 
Lecture 63Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 64NCE Vs. 505b2 application - Case Based Learning 
Lecture 65FTF - 180 Days Exclusivity - Case Based Learning
Lecture 66Classic case study of the 505b2 filing : Case Based Learning
Lecture 67Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 68What is meaning of 'Pipeline in a Molecule'?
Lecture 69USFDA Emergency Use Authorization (EUA)
Lecture 70Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 71Fundamental 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 72Review on Drug Discovery and Development 
Section 5Bioequivalence Study : Requirements
Lecture 73PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 74Bioequivalence Study | Study design | Different types of BE Studies
Lecture 75Bioequivalence 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 76Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 77Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 78Bioequivalence Study - Discussion - Dissolution Testing
Lecture 79Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 6Pharmacoeconomics | HEOR
Lecture 80Introduction to Health Economics | Key terminologies related to health economics.
Lecture 81HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 82Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 83Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 84Core 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 85Pharmacoeconomic 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 86Pharmacoeconomic 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 87Pharmacoeconomic 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 88Patient Based Forecasting Model | Applying more filters and variables
Lecture 89QALY | How to calculate QALY | Importance and Significance 
Lecture 90ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Lecture 91CER and PCOR
Section 7Market Access of Pharma and Biologics
Lecture 92Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 93Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 94Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 95Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 96Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 97AMCP Market Access Dossier Preparation 
Lecture 98Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 99Pharma Market Access Pricing Case Study: interchangeable Pricing 
Section 8Pharma Forecasting
Lecture 100Sales Forecasting in Life Science Industry
Lecture 101New Product Forecast Algorithm
Lecture 102Patient Based Forecasting Model | Applying more filters and variables
Lecture 103Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 104Prevalence Vs. Incidence Model
Lecture 105EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 106Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 107Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 108Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 109Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 110Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 111Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 112Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 113Simulation on Bottom-up forecasting
Lecture 114Assessment on Bottom-up forecasting
Lecture 115Oncology Brand Forecasting
Lecture 116Revenue Forecasting Case Study - Novel Antihypertensive 
Lecture 117Portfolio Based Forecasting | Forecasting Model Development in Excel 
Lecture 118First-in-class | Best-in-class | Market Access Strategic Decision Making 
Lecture 119Forecasting Biosimilar | Key Factors to consider
Lecture 120Consensus Meeting 
Lecture 121One Number Vs. Multi Number Forecasting
Lecture 122Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 123Treatment Algorithm and Forecasting : Case Based Learning
Lecture 124Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 125Prescription Value Calculation 
Section 9Pricing and Reimbursements
Lecture 126Drug Pricing Methodologies
Lecture 127Drug Pricing Methodologies - II
Lecture 128Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 129Pharma Market Access Pricing Case Study : Interchangeable Pricing
Lecture 130Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 131Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Section 10Evidence Generation | Real World Data | Real World Evidence
Lecture 132Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 133RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 134RWD and RWE in Product Lifecycle Management
Lecture 135RWD and RWE - Fit to use | Assessment
Lecture 136RWD data sources | Different types | Detailed understanding of each class 
Section 11Pharma Digital Marketing
Lecture 137Introduction to Digital Marketing 
Lecture 138Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 139Digital 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 140Digital 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 141Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 142Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 143Campaign 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 144Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 145Web Host - Check the hosting details 
Lecture 146Page Speed- importance and practical understanding | Check the web speed 
Lecture 147Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 148Mobile Responsive | Tracking the Site 
Lecture 149HCP sites and Patient Site
Lecture 150Google Ad - Practical Training on Campaign Development and Execution
Lecture 151Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 152Brand Portal Development
Lecture 153Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 154Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 155Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 156Difference between FMCG and OTC Brand Ad
Lecture 157Digital Marketing Techniques
Lecture 158Video Marketing
Lecture 159Video Marketing Techniques For Small Business Owners
Lecture 160Promoting Brand through Article Advertising and Marketing
Section 12Lead Generation | Management | Deal Structuring | Implementation
Lecture 161Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 162Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 163Compound Annual Growth Rate | CAGR Calculation
Lecture 164Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 165Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 166Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 167Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 168Numerical SWOT Practical training
Lecture 169Modelling 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 170Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 171Forecasting : Tools and Techniques
Lecture 172Market Sizing & Forecasting Case Study
Lecture 173Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 174Average Royalty Rate
Lecture 175Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 176Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 177Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 178Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 179SPECIAL PURPOSE VEHICLES (SPV)
Lecture 180Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 181Types of Deals from Discovery to Commercialization
Lecture 182What are the fundamental areas of business development
Lecture 183Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 184Licensing Payment Scheduling: Different Types
Lecture 185Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 186Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 187Negotiation 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 188Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 189Types 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 190Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 13Drug Safety | Pharmacovigilance
Lecture 191Introduction to Pharmacovigilance
Lecture 192Adverse Drug Reactions
Lecture 193ADR: Pharmacology
Lecture 194ADR: Classification
Lecture 195PV and ADR Monitoring
Lecture 196ADR and Related Terminologies
Lecture 197ADR Reporting System 
Lecture 198DoTS
Lecture 1994 Elements of AEs
Lecture 200ADR Reporting Limitations
Lecture 201ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 202The Adverse Drug Reaction (ADR) Probability Scale
Lecture 203Pharmacovigilance Process
Lecture 204PSURs
Lecture 205Risk Management
Section 14Regulatory Submission Management | Regulatory CMC Writing
Lecture 206Common Technical Document (CTD)
Lecture 207CMC Dossier & Compliance Management
Lecture 208Electronic Common Technical Document (ECTD)
Lecture 209Key Consideration for Drug Master File Preparation and Submission 
Lecture 210Practical Understanding on Drug Master File Preparation and Submission
Lecture 211Site Master File - Detailed Understanding 
Lecture 212Importance of effective dossier management
Lecture 213Discussion on 85 common deficiencies in CTD submission dossier
Lecture 214Detailed Understanding on ANDA Submission Dossier 
Section 15Preparing Clinical Study Report
Lecture 215How to prepare and write clinical study report
Lecture 216Example of Clinical Study Report : new medication for treating hypertension
Lecture 217Compare Clinical Study Report of 2 comparing medication
Lecture 218How to interpret clinical study report
Lecture 219Understanding RCT
Lecture 220Understanding Blinding
Lecture 221Publishing Clinical Study Reports