Introduction
Who should attend
Core Modules Covered
Features
Related Courses
Why Pharma R&D Training?
Certification Details
1-Year Flagship Online Training Program | Pharma R&D Management Skill Development Program | 100% Self-Paced
The Post Graduate Certification in Pharma Research and Development (R&D) by Royed Training is a comprehensive and industry-aligned online program designed to equip participants with practical skills and strategic insights into the complete lifecycle of pharmaceutical R&D. This flagship 1-year program is curated for aspiring and working professionals who want to build a successful career in formulation development, analytical research, regulatory science, clinical research, and project management within the pharmaceutical and biopharmaceutical sectors.
With a focus on real-world application, the program combines interactive lectures, simulations, assignments, and case-based learning to ensure deep conceptual understanding and functional expertise across discovery, development, and submission stages of R&D.
Key details about the course:
- Course Code: RYD-137
- Title: PG Certification in PG Certification in Pharma Research and Development (R&D) [PGPR&D]
- 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 be 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 : Min. qualification Graduation in Science (BSc / MSc) / Pharmaceuticals / BTech
This program is ideal for:
- Pharmacy, life sciences, chemistry, or biotechnology graduates
- Freshers seeking entry into pharma R&D departments
- Working professionals in QA, QC, RA, Clinical, or Production roles seeking transition
- Junior R&D professionals aiming to strengthen their end-to-end knowledge
- Entrepreneurs and startup founders in pharma R&D
- Regulatory and CMC professionals handling R&D documentation
Core Modules Covered in the Pharma Research and Development (R&D) Course
- Introduction to Pharma R&D & Industry Landscape
- Drug Discovery and Preclinical Development
- Formulation and Analytical R&D
- Clinical Trials and Development Phases (I–IV)
- Regulatory Affairs for R&D (IND, NDA, ANDA, CTA, eCTD)
- CMC Documentation and Quality by Design
- Biosimilar and Biotech Product R&D
- Project Management and Portfolio Strategy
- Data Integrity, GMP/GLP/GCP, and QA in R&D
- Digital Innovation, AI, and Real-World Evidence in R&D
- Final Capstone Project and Evaluation
What you will learn in Pharma R&D Management Course:
- Scientific and regulatory principles of drug discovery and development
- Design and execution of preclinical and clinical studies
- Formulation and analytical development strategies
- CMC documentation and regulatory writing (eCTD/ACTD)
- Quality, data integrity, and compliance in R&D
- Project and portfolio management in pharmaceutical R&D
- Digital tools, AI/ML, and real-world evidence in modern R&D workflows
- Biosimilar and biotech product development overview
Features of Pharma Research and Development (R&D) Course
- 12-Month Self-Paced Program — Learn at your convenience with guided timelines
- Structured R&D Lifecycle Coverage — From molecule discovery to regulatory submission
- 100+ Case Studies & Real-World Simulations — Scenario-based industry application
- Capstone Project with Evaluation — Create and present a complete R&D strategy dossier
- Mentor-Guided Support — Guidance from experienced pharma professionals
- Globally Recognized PG Certificate — For career advancement and specialization
Few of the Pharma R&D Related Courses
Why Choose Royed Training’s Pharma Research and Development (R&D) Training Course?
In today’s competitive pharmaceutical landscape, professionals need more than just academic knowledge to succeed in Research and Development (R&D). Royed Training’s PG Certification in Pharma Research and Development (R&D) is a comprehensive online course designed to equip learners with real-world, industry-ready skills. Unlike traditional training programs, this course integrates practical simulations, case studies, and project-based learning that mirrors actual R&D workflows—from drug discovery and formulation to clinical trials and regulatory submissions.
What sets Royed Training apart is its deep industry focus. The curriculum is developed by experienced professionals who understand the intricacies of modern drug development. With modules covering formulation development, analytical R&D, CMC documentation, data integrity, and biotech innovation, learners gain a 360-degree understanding of the R&D process. This self-paced, 12-month course also emphasizes the application of digital tools and artificial intelligence in R&D—making it ideal for those looking to future-proof their careers in pharma and biopharma sectors.
Whether you are a fresh graduate aiming to break into pharmaceutical R&D or a working professional looking to transition into a high-growth function, Royed Training’s program provides the right mix of flexibility, depth, and relevance. The globally recognized certification, hands-on capstone project, and personalized career guidance ensure that learners emerge confident and job-ready. If you’re serious about advancing in pharma R&D, this flagship course is your gateway to real impact and success.
Certification and Related Details
- Certification Title: PG Certification in Pharma Research and Development (R&D)
- Certificate: Course Completion Certificate, Course Gradation Certificate
- Duration: 12 Months (flexible with monthly milestones)
- Mode: 100% Online | Access 24×7
- Project: Capstone submission + Viva-style defense
- Award: PG Certificate with Digital Badge and Social Media Credentials
Section 1Pharma R&D Process - Discovery Development to Commercialization
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Purple Book: Significance | Searching | Assignments
Lecture 9Handling of orange book
Lecture 10USFDA expedited programs
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16Orphan Drug Designation
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Importance and Significance of Phase 2b Clinical Trial
Lecture 27Regulatory Strategies in different phases of Clinical Trial
Lecture 28Para IV Filing - Strategic Insight
Lecture 29Para IV Notices
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31Pay For Delay Strategy
Lecture 32REMS Strategic Planning
Lecture 33Compulsory Licensing
Lecture 34Licensing & Technology Transfer
Lecture 35In-Licensing Vs. Outlicensing
Lecture 36LOE Strategies for Innovator Brands with case study
Lecture 37Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 38Drug Repurposing
Lecture 39Advance understanding of the portfolio Management
Lecture 40New Indication Approval Process and Promotion
Lecture 41OTC Switch
Lecture 42Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 43NCE Vs. 505b2 application - Case Based Learning
Lecture 44FTF - 180 Days Exclusivity - Case Based Learning
Lecture 45Classic case study of the 505b2 filing : Case Based Learning
Lecture 46Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 47Pipeline in a molecule | Case Study
Lecture 48USFDA Emergency Use Authorization (EUA)
Lecture 49Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 50Fundamental 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 51Review on Drug Discovery and Development
Section 2R&D to Commercialization - Europe
Lecture 52Introduction to EU Regulation
Lecture 53Orientation to European Countries and National Regulatory Bodies
Lecture 54EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 55Overview of EU Regulation
Lecture 56EMA and EMA Authorisation Process
Lecture 57EU MA Application Types and Strategic Planning
Lecture 58EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 59EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 60Validity 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 61Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 62EU Orphan Medicinal Products Regulation
Lecture 63Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 64Summary of Product Characteristics
Lecture 65Compassionate Use
Lecture 66MHRA - UK Regulation
Lecture 67The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 68Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 69EU Prime Designation
Lecture 70Accelerated assessment by EMEA
Lecture 71EU Adaptive Pathway
Lecture 72European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 73SPOR - Concept of Master Data Management
Section 3R&D Innovation Management - IPR Management
Lecture 74Introduction to intellectual Property Management
Lecture 75Introduction to Patent
Lecture 76Understanding on Patent System
Lecture 77Patent Grant and Managing Patent Filing Procedure
Lecture 78Scope of Patentability
Lecture 79Patent Grant and Handling Process in India
Lecture 80Stages of Patent Grant Procedure
Lecture 81Patent search in Indian Patent Office
Lecture 82Differences in US and European Patent
Lecture 83Patent Claim | Types of Patent Claims
Lecture 84Patent Cliff | How to calculate the patent cliff
Lecture 85Terminologies related to patent, trademark, copyright and licensing
Lecture 86Patent Infringement
Lecture 87Introduction to Trademark | Trademark filing procedure
Lecture 88Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 89Trademark Infringement | Passing off | Practical Cases
Lecture 90Trademark Classes | How to search the right trademark class for for filing trademark application
Section 4R&D to Commercialization - Strategic Planning Process
Lecture 91Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 92Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 93Introduction to Health Economics | Key terminologies related to health economics.
Lecture 94HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 95Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 96Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 97Core 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 98Pharmacoeconomic 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 99Pharmacoeconomic 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 100Pharmacoeconomic 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 101Patient Based Forecasting Model | Applying more filters and variables
Lecture 102QALY | How to calculate QALY | Importance and Significance
Lecture 103ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination
Lecture 104CER and PCOR
Lecture 105Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 106Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 107Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 108AMCP Market Access Dossier Preparation
Lecture 109Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 110Drug Pricing Methodologies - I
Lecture 111Drug Pricing Methodologies - II
Lecture 112Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 113Pharma Market Access Pricing Case Study: interchangeable Pricing
Lecture 114Sales Forecasting in Life Science Industry
Lecture 115New Product Forecast Algorithm
Lecture 116Patient Based Forecasting Model | Applying more filters and variables
Lecture 117Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 118Prevalence Vs. Incidence Model
Lecture 119EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 120Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 121Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 122Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 123Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 124Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 125Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 126Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 127Simulation on Bottom-up forecasting
Lecture 128Assessment on Bottom-up forecasting
Lecture 129Oncology Brand Forecasting
Lecture 130Revenue Forecasting Case Study - Novel Antihypertensive
Lecture 131Portfolio Based Forecasting | Forecasting Model Development in Excel
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
Lecture 137First-in-class | Best-in-class | Market Access Strategic Decision Making
Lecture 138Forecasting Biosimilar | Key Factors to consider
Lecture 139Consensus Meeting
Lecture 140One Number Vs. Multi Number Forecasting
Lecture 141Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 142Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 143Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 144Treatment Algorithm and Forecasting : Case Based Learning
Lecture 145Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 146Prescription Value Calculation
Lecture 147Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier
Lecture 148Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing
Lecture 149Budget Impact Analysis | Importance | Significance | Steps involved | Total Budget Impact Calculation | Simulation - BIA of novel molecule with real life example | Total Budget Impact Calculation for Novel Molecule
Lecture 150Markov Model | Significance | Importance | Time horizon - Significance | Real Life Development of Markov Model | Calculation
Lecture 151Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation
Lecture 152HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes
Section 5R&D Business Development | Licensing
Lecture 153Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 154Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 155Compound Annual Growth Rate | CAGR Calculation
Lecture 156Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 157Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 158Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 159Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 160Numerical SWOT Practical training
Lecture 161Modelling 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 162Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 163Forecasting : Tools and Techniques
Lecture 164Market Sizing & Forecasting Case Study
Lecture 165Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 166Average Royalty Rate
Lecture 167Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 168Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 169Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 170Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 171SPECIAL PURPOSE VEHICLES (SPV)
Lecture 172Indication Splitting | Concept | Implementation feasibility analysis
Lecture 173Types of Deals from Discovery to Commercialization
Lecture 174What are the fundamental areas of business development
Lecture 175Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 176Licensing Payment Scheduling: Different Types
Lecture 177Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 178Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 179Negotiation 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 180Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 181Types 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 182Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects
Lecture 183DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 184Net Present Value (NPV) method : Calculation
Lecture 185Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium
Lecture 186Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 187Comparable Company Analysis method : Calculation
Lecture 188EBITDA Multiples | Importance in Pharma Biopharma BD&L | Calculation | Benchmarking EBITDA multiplies | Sourcing EBITDA multiples | Decoding EBITDA multiples value in different types of pharma and biopharma organizations
Lecture 189Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development
Lecture 190Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 191Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 192Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker
Lecture 193Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise
Lecture 194WACC in Biopharma Valuation | Significance | WACC benchmarking
Lecture 195WACC Calculation | Step by Step Calculation | Insight on WACC components
Lecture 196rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting
Lecture 197Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV
Lecture 198Real Options Valuation (ROV) for Biopharma assets | Model Development | Calculation | Case Based Insight in the context of inlicensing and outlicensing | Early stage asset valuation with ROV
Lecture 199ROV Scenario Based Case Study
Lecture 200Biotech Decision Tree Model with Decision Reasoning
Section 6Biologic and Biosimilar R&D Management
Lecture 201Introduction : Biopharmaceuticals
Lecture 202Classification of Biopharmaceutical
Lecture 203Important Concept regarding Biopharmaceuticals
Lecture 204Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 205Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 206Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 207Global Biopahrma Market Trends
Lecture 208Recombinant protein
Lecture 209Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 210Monoclonal Antibodies
Lecture 211Synthetic Immunomodulators
Lecture 212Production of Monoclonal Antibodies
Lecture 213Cytokines
Lecture 214Interferon
Lecture 215Erythropoiesis-stimulating agent
Lecture 216Vaccine development and approval Process
Lecture 217Biosimilar Development Process
Lecture 218Strategic Consideration for Biosimilar Development
Lecture 219Bio-Manufacturing Process Information
Lecture 220Studies required for approval of biosimilar
Lecture 221ATMPs | Types and Classification | Regulatory Mechanism
Lecture 222Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management
Lecture 223Biosimilar launch case study | Patent Dance Framework
Lecture 224Biosimilar Launch Framework
Lecture 225Biosimilar 180 Day Notice
Lecture 2263(A) List | Significance | Importance | How to interpret
Lecture 227Steps to win over innovator patents | Step wise planning
Lecture 228Biosimilar Launch Project Roadmap with defined stages of project
Lecture 229Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments
Lecture 230Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation
Lecture 231How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 232Biosimilar Launch Project With Milestones
Lecture 233Analysis of Biologic Patents | Work Assignments
Lecture 234Biologic Patent Insight Worksheet
Lecture 235Patent Thickets | Concept | Implication | Case Based Learning
Section 7Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 236Introduction to Common Technical Document (CTD)
Lecture 237CMC Dossier & Compliance Management
Lecture 238Introduction to Electronic Common Technical Document (ECTD)
Lecture 239Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 240Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 241Key Consideration for Drug Master File Preparation and Submission
Lecture 242Practical Understanding on Drug Master File Preparation and Submission
Lecture 243Associated Learning: Site Master File - Detailed Understanding
Lecture 244DMF Completeness Assessment
Lecture 245Drug Master File - Fees
Lecture 246Drug Master File - Global Perspective [Across Different Regions]
Lecture 247Importance of effective dossier management
Lecture 248Discussion on 85 common deficiencies in CTD submission dossier
Lecture 249Certificate of Analysis
Lecture 250Detailed Understanding on ANDA Submission Dossier
Lecture 251Prior Approval Submission
Lecture 252Detailed Understanding on ANDA Fees
Lecture 253Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 254NCE Vs. 505b2 application - Case Based Learning
Lecture 255FTF - 180 Days Exclusivity - Case Based Learning
Lecture 256Classic case study of the 505b2 filing : Case Based Learning
Lecture 257Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 258Climatic Zone and Stability Study Conditions as per ICH Guidelines
Lecture 259Stability Zone Finder
Lecture 260Stability Studies Case Discussions
Lecture 261Case Study: Managing Stability Study for Zone IV countries
Lecture 262Accelerated and intermediate testing conditions
Lecture 263Long Term Stability Testing Requirements
Lecture 264Testing Frequency
Lecture 265Bracketing
Lecture 266Matrixing
Lecture 267Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Section 8Bioequivalence Study : Requirements
Lecture 268PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 269Bioequivalence Study | Study design | Different types of BE Studies
Lecture 270Bioequivalence 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 271Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 272Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 273Bioequivalence Study - Discussion - Dissolution Testing
Lecture 274Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 275IVIVC - Basis | Importance | Case Based Determination of IVIVC
Lecture 276Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 277Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Section 9Variation Filing : Marketing Authorization variation management
Lecture 278Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 279Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 10Plant Management and Certification | Quality Management
Lecture 280Premises & Plant Layout Designing
Lecture 281Sanitation and Hygiene
Lecture 282Equipment Modules
Lecture 283Production Modules
Lecture 284Documentation
Lecture 285Quality Control
Lecture 286Product Complaint
Lecture 287Storage Module
Lecture 288Pharmaceutical SOPs Management from regulatory perspective
Lecture 289Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 290Data Integrity issues in Pharmaceutical Industry
Lecture 291Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 292Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Section 11Certification Request | Course Certificate
