InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 / 27500 INR
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Drug dossier preparation 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.

The Drug Dossier Preparation Training course is a comprehensive program designed to equip professionals with the knowledge, skills, and techniques required to create high-quality regulatory dossiers for pharmaceutical and biopharmaceutical products. Dossiers play a pivotal role in the approval and marketing of drugs, making this training essential for regulatory affairs professionals, pharmaceutical researchers, quality control experts, and anyone involved in the drug development and registration 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.

Course Snapshot

  • Course Code: RYD-024
  • Course Title: Advanced Certification in Drug Dossier Preparations and Filing (ACDDPF)
  • Duration: 1 Month
  • Types of Learning: 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.
  • 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 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 Drug Dossier Preparation 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, the course provides advanced simulation to real life working in drug dossier preparation and submission process.
  • Therefore, this course helps to understand 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 regarding Drug Dossier training course

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.

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.

Drug Dossier Preparation and Filing covers a comprehensive set of procedures and guidelines for preparing and filing drug dossiers, which are essential documents submitted to regulatory agencies for the approval of pharmaceutical products. Let’s understand the key sections of the drug dossier preparation training:

Regulatory Requirements Understanding

Understand the regulatory requirements of the target market(s) where the drug will be marketed. Different countries or regions may have distinct regulatory frameworks and submission requirements. Hence, we provide clear and comprehensive training so that person involved in the dossier preparation can have detailed orientation before they start with the dossier compilation process. 

Dossier Compilation

Compile all necessary documents required for the dossier submission. This may include preclinical study reports, clinical trial data, manufacturing details, quality control information, pharmacovigilance data, labeling, and packaging information.

Formatting and Structure

This course provides the specified format and structure for the dossier as per regulatory guidelines. This typically includes sections such as administrative information, chemistry, manufacturing, and controls (CMC), nonclinical data, clinical data, safety updates, labeling, and packaging.

Clinical Data Summary

The course comprehensively trains to summarize the clinical trial data, including efficacy and safety results. 

Nonclinical Data Summary

This course summarizes the nonclinical (preclinical) studies conducted to assess the safety profile of the drug.

Chemistry, Manufacturing, and Controls (CMC)

Hands- on training is provided on the information about the drug substance, drug product, and manufacturing processes. Include data on raw materials, manufacturing methods, process controls, and stability studies.

Stability Study 

Understanding of stability study is the key for preparing a dossier. Hence this course provides hands-on training on stability study. 

Labeling and Packaging

Course includes proposed labeling and packaging materials, ensuring compliance with regulatory requirements regarding safety information, dosage instructions, and warnings.

Submission Preparation and Filing Management 

Comprehensive ready dossier provides in the course, to provide hands on understanding how to assemble all documents into the required format for submission, ensuring completeness and accuracy.

Post-Submission Activities

A regulatory person involved in the dossier preparation must promptly answer questions or requests for clarification from regulatory authorities during the review process. Address any deficiencies or concerns raised by the regulatory agency.

This is a top degree view of the content of the dossier preparation and filing course. For more detailed topic orientation please refer to the lecture lists.

Drug Dossier Preparation 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 entire dossier preparation training topics.

Some related courses

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