InstructorRoyed Training
TypeOnline Course
Price$290 / 15950 INR
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drug dossier preparation and filing training



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Drug Dossier Preparation and Filing

The online Drug Dossier Preparation and filing provides practical training on drug registration dossier preparation and submission process. In fact, this course provides real life training on how to prepare drug submission dossier effectively. Hence, This online certificate course in drug dossier preparation and registration is ideal for regulatory affairs, Quality personnel, Business Development and International Marketing professionals working in the pharmaceutical industry. Moreover, this course gives hands-on training through simulation on dossier preparation, which helps to improve the dossier compilation process.

Online Interactive 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 Code: RYD-024

Course Title: Competency Development Program in Drug Dossier Preparations and Filing

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. 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. Therefore it helps the students to identify the marketing tools and techniques which are commonly used in the pharmaceutical industry.
  • Most importantly, course provides advanced simulation to real life working in drug dossier preparation and submission process.
  • Therefore, this course helps to understand submission requirement specific to regulatory agency.
  • Above all, this course provides access to sample dossier 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. drug dossier preparation and filing

Key Points to Note:

First of all, this course provides practical understanding in 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 comes with the how to prepare the different sections of dossier. In fact, insight is provide on Page by page development of Drug Dossier Preparation.

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.

Online learning course. So course can be accessed online across anywhere 24×7.

Graduation in any discipline. Even final year graduation students can apply.

1 Week from the date of initiation of the course.

  1. Attend the course 24×7 by login to your dashboard. Therefore, you can attend lectures, simulation, self assessment tests and final certification examination at your own preferred time.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Certificate will be provided at the end of the successful completion of the course.

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Section 1Learning Content
Lecture 1Detailed understanding on Common Technical Document (CTD)
Lecture 2Chemistry, Manufacturing & Controls 
Lecture 3CMC Dossier & Compliance Management
Lecture 4Electronic Common Technical Document (ECTD)
Lecture 5Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 6Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 7Importance of effective dossier management
Lecture 8Certificate of Analysis
Lecture 9Detailed Understanding on ANDA Submission Dossier 
Lecture 10Prior Approval Submission 
Lecture 11Detailed Understanding on ANDA Fees
Lecture 12Advance Learning on 505B2 Pathway
Lecture 13Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 14NCE Vs. 505b2 application - Case Based Learning 
Lecture 15FTF - 180 Days Exclusivity - Case Based Learning
Lecture 16Classic case study of the 505b2 filing : Case Based Learning
Lecture 17Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 18Asean Common Technical Document (ACTD) 
Lecture 19Discussion on 85 common deficiency in CTD submission dossier
Lecture 20Key Consideration for Drug Master File Preparation and Submission 
Lecture 21Practical Understanding on Drug Master File Preparation and Submission
Lecture 22Site Master File - Detailed Understanding 
Lecture 23DMF Completeness Assessment
Lecture 24Drug Master File - Fees
Lecture 25Drug Master File - Global Perspective [Across Different Regions]
Lecture 26Data Integrity issues in Pharmaceutical Industry
Lecture 27Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 28Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 29Stability Study: Climate Zone
Lecture 30Stability Zone Finder
Lecture 31Stability Studies : Case discussions
Lecture 32Stability Data for Zone IV countries
Lecture 33Accelerated and intermediate testing conditions
Lecture 34Long Term Stability Testing Requirements
Lecture 35Stability Study Protocol Development - Dosage form: Capsule
Lecture 36Stability Data Sheet
Lecture 37Dossier Stability Test
Lecture 38Testing Frequency
Lecture 39Bracketing
Lecture 40Matrixing
Lecture 41PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 42Bioequivalence Study | Study design | Different types of BE Studies
Lecture 43Bioequivalence 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 44Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 45Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 46Bioequivalence Study - Discussion - Dissolution Testing
Lecture 47Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 48Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 49Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 50Introduction 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 51WHO-GMP Certification Scheme 
Lecture 52Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 2Certification Examination