InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$180 USD / 7500 INR
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drug dossier preparation and filing



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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. This PG certification course provides real life training on how to preparation drug submission dossier effectively. 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 pharmaceutical industry. This course gives practical real life  simulation on dossier preparation. 

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 provide practical training on drug dossier preparation and submission. Therefore it helps the students to identify the marketing tools and technique which commonly used in pharmaceutical industry.
  • Simulation to real life working in drug dossier development.
  • Understanding Decision Making and Strategy Creation in the field of country specific drug registration
  • Above all, this course provide access to sample dossier to work and develop competency. Certainly, accessing these real life dossier can be helpful for students to understand section wise requirement for the dossier preparation.

Key Points to Note:

1. Orientation to practical understanding in the entire drug regulation in brief, drug registration process of different regulatory bodies and practical exposure on Drug Dossier Preparation.

2. Understanding on Drug Dossier and its components. Technical Documents and guidelines on dossier preparation.

2. Simulation to real life Strategic planning in Drug Registration Process

3. Page by page development of Drug Dossier Preparation.

4. Attend Live Lectures of all different chapters / study content.

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
Section 2Certification Examination