Introduction
Features
Related Courses
Who should attend
About CMC Writing
The online CMC writing training provides practical training on Chemistry, Manufacturing and Controls (CMC) requirements for drug applications. In fact, the course provides review processes for preformulation, non-clinical to clinical trial regulatory requirements for registration and post approval drug applications. Moreover, the course provides hands-on real life training on how to prepare drug submission dossiers. Hence, This online certificate course in CMC writing is ideal for CMC specialists, regulatory affairs professionals who are handling regulatory filing. Most importantly, this CMC writing course gives hands-on training through simulation on CMC preparation and strategic planning process, which helps to improve the dossier compilation process.
Online Interactive Regulatory CMC Writing Training
This online self paced training. Therefore the course can be accessed 24×7 across anywhere. Hence, the course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Snapshots:
- Course Code: RYD-98
- Title of the course: Advanced Certification in Regulatory CMC Writing
- Duration: 1 Month.
- Nature of the course: Online learning course. So the course can be accessed online anywhere 24×7.
- Eligibility : Graduation in any discipline. Even final year graduation students can apply.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
This online course utilizes interactive learning tools to guide each participant through the steps of CMC Writing process for different regulatory bodies and practical exposure in pre and post submission management. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Features of the Course:
- The course provides practical training on drug dossier preparation and submission with more emphasis on cmc writing sections with simulations.
- Therefore it helps the students to develop and nurture CMC writing skills.
- Most importantly, the course provides advanced simulation to real life working in drug dossier preparation and submission process.
- Therefore, this course helps to understand CMC and dossier submission requirements specific to regulatory agencies.
- Above all, this course provides access to sample dossiers to work and develop competency. Certainly, accessing these real life dossiers can be helpful for students to understand section wise requirements for the dossier preparation.
Key Points to Note:
Royed Training’s CMC Writing course is having unquietly designed comprehensive curriculum covering regulatory guidelines, technical writing skills, and real-world applications. First of all, this course provides practical understanding of the entire drug submission requirement specific to different regulatory bodies. Secondly, hands-on training is provided on key aspects of the drug dossier preparation with focus on guidelines on dossier preparation. Thirdly, courses come with how to prepare the different sections of the dossier. In fact, insight is provided on Page by page development of Drug Dossier Preparation. Moreover, the course provides more emphasis on CMC section writing.
Next, one more important point is, this course provides comprehensive understanding on drug master file and site master file preparation.
To add a note, comprehensive eCTD filing, stability study, documentation error, data integrity and other dossier filing is part of this course.
Above all, There are Unique modules on Error Handling and Response to Regulatory Queries to build confidence in managing complex documentation challenges.
Some related courses
CMC Writing training content is also part of the International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Therefore, a separate course is not required if you already taking EPGIDRA or PGDBMRA course. We also have dedicated Drug Dossier Preparation course which covers the CMC writing.
- Drugs, Biologics, Medical Devices Regulatory Affairs Course
- International Drug Regulatory Affairs
- Pharmaceutical International Business Management
- Drug Regulatory Affairs Course
- ANDA filing
- Stability Study
- Drug Dossier Preparation
This CMC writing training is ideal for the working professionals who are responsible for the R&D and Technical Writing, Quality Control and Quality Assurance Professionals, Regulatory Professionals specially working in CMC area pre and post approval.
- CMC Specialist
- Regulatory Affairs
- Post approval variation specialist
- QA/QC
- Process Chemistry
- Scale-up and Technology Transfer
- Preformation and Formulation Development
- Analytical Chemistry
Section 1Drug Discovery and Development Fundamental
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) Filing
Lecture 6Exploratory IND Vs. Traditional IND
Lecture 7Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 8USFDA expedited programs
Lecture 9EMA and EMA Authorisation Process
Lecture 10EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 11IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 12Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 13Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Section 2Preformulation Studies
Lecture 14Preformulation Study in Drug Development
Lecture 15Regulatory Requirements for Preformulation Study
Lecture 16Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Section 3Regulatory Requirements for Non-Clinical Studies
Lecture 17Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 18Types and Timing of Non-clinical Studies
Section 4Regulatory Requirements for Clinical Studies
Lecture 19Understanding on Clinical Trials and Clinical Research
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 5ICH Guideline
Lecture 23Introduction to ICH | Members | Guidelines
Lecture 24ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 25ICH Q2 : Analytical Validation
Lecture 26ICH Q3 : Impurities
Lecture 27Rest of ICH Q Family Guidelines
Section 6Managing CMC requirements
Lecture 28Chemistry, Manufacturing & Controls
Lecture 29Fundamental 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 30505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 31Advance Learning on 505B2 Pathway
Lecture 32EU MA Application Types and Strategic Planning
Section 7Dossier Preparation
Lecture 33Introduction to Common Technical Document (CTD)
Lecture 34CMC Dossier & Compliance Management
Lecture 35Key Consideration for Drug Master File Preparation and Submission
Lecture 36Practical Understanding on Drug Master File Preparation and Submission
Lecture 37Associated Learning: Site Master File - Detailed Understanding
Lecture 38Drug Master File - Fees
Lecture 39Drug Master File - Global Perspective [Across Different Regions]
Lecture 40Electronic Common Technical Document (ECTD)
Lecture 41Certificate of Analysis
Lecture 42Asean Common Technical Document (ACTD)
Lecture 43Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Section 8Dossier Submission and Management
Lecture 44FDA Forms and How to fill the resources
Lecture 45Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 46Importance of effective dossier management
Lecture 47Discussion on 85 common deficiencies in CTD submission dossier
Lecture 48Detailed Understanding on ANDA Submission Dossier
Lecture 49Prior Approval Submission
Lecture 50Detailed Understanding on ANDA Fees
Lecture 51Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 52NCE Vs. 505b2 application - Case Based Learning
Lecture 53FTF - 180 Days Exclusivity - Case Based Learning
Lecture 54Classic case study of the 505b2 filing : Case Based Learning
Lecture 55EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 56Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 57OGD Table - How to Prepare | Sample Tabular Summary Preparation
Section 9Stability Study
Lecture 58Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 59Climate Zone
Lecture 60Stability Zone Finder
Lecture 61Stability Studies : Case discussions
Lecture 62Stability Data for Zone IV countries
Lecture 63Accelerated and intermediate testing conditions
Lecture 64Long Term Stability Testing Requirements
Lecture 65Stability Study Protocol Development - Dosage form: Capsule
Lecture 66Stability Data Sheet
Lecture 67Dossier Stability Test
Lecture 68Testing Frequency
Lecture 69Bracketing
Lecture 70Matrixing
Section 10BA BE Study
Lecture 71PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 72Bioequivalence Study | Study design | Different types of BE Studies
Lecture 73Bioequivalence 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 74Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 75Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 76Bioequivalence Study - Discussion - Dissolution Testing
Lecture 77Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 78BA BE Study Design | Comparing different types of the study design
Lecture 792wco Study Design | Design Table | Importance
Lecture 803wco Study Design | Design Table | Importance
Lecture 81FRCO Study Design | Design Table | Importance
Lecture 82OGD Table - How to Prepare | Sample Tabular Summary Preparation
Section 11Post Approval Changes and Variation Management
Lecture 83Variation Management | Reasons for Variation | Working in Variation Department
Lecture 84Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 85EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 86Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Section 12Quality Issues | Post Filing Regulatory Queries | Response to Queries (RTQs) | Critical Issues in Submission Management
Lecture 87Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 88Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 89Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 90RTQs | Response to Queries | How to handle Regulatory Queries
Section 13Biologic CMC Requirements
Lecture 91Biosimilar Development Process
Lecture 92Strategic Consideration for Biosimilar Development
Lecture 93Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 94Studies required for approval of biosimilar
Lecture 95Comparability of Biologics | Different Categories of Comparability | General Principles
Section 14Differentiating CMC and Regulatory Writing with Medical and Scientific Writing
Lecture 96Introduction to Medical Writing | Objective | Significance | Medical Writing Vs. Scientific Writing | Key Notes
Lecture 97Types of Medical Writing | Regulatory Writing | CMC Writing | Clinical Writing | Documents under each class of medical writing
Lecture 98Ethical Consideration of Medical Writing | Important Considerations | Effective strategies for each ethical consideration | Case studies
Lecture 99Regulatory Documents | Classification of regulatory documents | Understanding of each class of documents | Ethical consideration for Regulatory Writing
Lecture 100Publication Writing and Regulatory Writing | Key Differences with Examples
Lecture 101Regulatory Writing - Review Test
Lecture 102Hands on Case Study Protocol Designing for Experimental Asthma Drug | Analysis of various aspect of protocol | Open File
Lecture 103Drafting of Study Objective Methodology and Endpoint | Checklist
Section 15Reference | Discussions | CMC Case Studies
Lecture 104Comparison of Requirement of Various Regulatory Bodies
Lecture 105Comparison of Dossier Requirements of Europe and US
Lecture 106Comparison of DMF requirement of various regulatory bodies
Lecture 107ICH Guidelines - Comprehensive View
Lecture 108ICH CTD Top Level View with Notes and Explanation
Lecture 109Comparison of ICH US EU CTD
Lecture 110Regulatory Documents - At a glance
Lecture 111Structured CMC Writing Checklist
Lecture 112CMC Writing Case Study | Successful Documentation
Lecture 113Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 114Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 115Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 116Example of Well-Written Drug Substance Characterization | Impurities and Degradation Products | Well-Written Impurities and Degradation Products | Synthesis and Manufacturing Processes | Control of Drug Substance (Specifications, Testing, and Acceptance Criteria)
Lecture 117Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 118Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 119CEP Dossier DMF - Differences
Lecture 120Developing Specifications for a New API
Lecture 121Example of Manufacturing Process and Controls
Lecture 122Interpretation of Stability Table
Lecture 123Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 124Critical Stability Issues - Database | Implication | Action Plan
Lecture 125Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Lecture 126Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 127Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 128Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 129Binding and Non-binding legal considerations - Module 3 Quality in CMC Section | Case Studies
Lecture 130Binding and Non-binding Scenarios with Examples
Section 16WHO Certification Scheme | Documentation
Lecture 131Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning
Lecture 132WHO-GMP Certification Scheme
Lecture 133Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 134WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 135WHO EML Vs. WHO PQ | Significance | Importance in Market Access and Regulatory point of view
Section 17Course Certification
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