InstructorRoyed Training
TypeOnline Course
Student Enrolled5
Price$590 / 29500 INR
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regulatory cmc writing course

Introduction

Features

Related Courses

About CMC Writing

Regulatory CMC writing training

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.

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

Course Snapshots:

  • Course Code: RYD-98 
  • Title of the course: Advanced Certification in Regulatory CMC Writing
  • Duration: 1 Month. Free extendable up to 3 months.
  • 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:

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.

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.

 

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) 
Section 8Dossier Submission and Management
Lecture 43FDA Forms and How to fill the resources
Lecture 44Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 45Importance of effective dossier management
Lecture 46Discussion on 85 common deficiencies in CTD submission dossier
Lecture 47Detailed Understanding on ANDA Submission Dossier 
Lecture 48Prior Approval Submission 
Lecture 49Detailed Understanding on ANDA Fees
Lecture 50Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 51NCE Vs. 505b2 application - Case Based Learning 
Lecture 52FTF - 180 Days Exclusivity - Case Based Learning
Lecture 53Classic case study of the 505b2 filing : Case Based Learning
Lecture 54EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Section 9Stability Study
Lecture 55Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 56
Lecture 57Stability Zone Finder
Lecture 58Stability Studies : Case discussions
Lecture 59Stability Data for Zone IV countries
Lecture 60Accelerated and intermediate testing conditions
Lecture 61Long Term Stability Testing Requirements
Lecture 62Stability Study Protocol Development - Dosage form: Capsule
Lecture 63Stability Data Sheet
Lecture 64Dossier Stability Test
Lecture 65Testing Frequency
Lecture 66Bracketing
Lecture 67Matrixing
Section 10BA BE Study
Lecture 68PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 69Bioequivalence Study | Study design | Different types of BE Studies
Lecture 70Bioequivalence 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 71Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 72Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 73Bioequivalence Study - Discussion - Dissolution Testing
Lecture 74Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 11Post Approval Changes and Variation Management
Lecture 75Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 76Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 77EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Section 12Quality Issues | Post Filing Regulatory Queries | Response to Queries (RTQs) | Critical Issues in Submission Management
Lecture 78Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 79Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 80Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 81RTQs | Response to Queries | How to handle Regulatory Queries
Section 13Biologic CMC Requirements
Lecture 82Biosimilar Development Process
Lecture 83Strategic Consideration for Biosimilar Development 
Lecture 84Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 85Studies required for approval of biosimilar
Lecture 86Comparability of Biologics | Different Categories of Comparability | General Principles
Section 14Differentiating CMC and Regulatory Writing with Medical and Scientific Writing
Lecture 87Introduction to Medical Writing | Objective | Significance | Medical Writing Vs. Scientific Writing | Key Notes 
Lecture 88Types of Medical Writing | Regulatory Writing | CMC Writing | Clinical Writing | Documents under each class of medical writing  
Lecture 89Ethical Consideration of  Medical Writing | Important Considerations | Effective strategies for each ethical consideration | Case studies 
Lecture 90Regulatory Documents | Classification of regulatory documents | Understanding of each class of documents | Ethical consideration for Regulatory Writing
Lecture 91Publication Writing and Regulatory Writing | Key Differences with Examples 
Lecture 92Regulatory Writing - Review Test 
Lecture 93Hands on Case Study Protocol Designing for Experimental Asthma Drug | Analysis of various aspect of protocol | Open File 
Lecture 94Drafting of Study Objective Methodology and Endpoint | Checklist