InstructorRoyed Training
TypeOnline Course
Price$490 USD / 27500 INR.
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usfda regulatory affairs training


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US FDA regulatory affairs course

The US FDA regulatory affairs certification training course is to train pharmaceutical, biopharmaceutical regulatory approval processes in the US. The course provides comprehensive training on fundamental regulatory topics. For example, understanding about investigational new drug, and biologics development and approval process, submission dossier preparation, filing steps etc. Moreover, upon completion of the fundamental section, you will move to the next level which is advanced strategic planning on portfolio management. Hence, this course is ideal for the effective training of Regulatory Affairs personnel. Above all, this US Regulatory Affairs training course gives practical knowledge and real life job simulation. Course focuses on how regulatory professionals work in a company and understanding of key responsibilities and job functions.

This US FDA regulatory affairs course is online self-paced learning. Therefore participants can attend the course at its own convenient time 24×7.

  • Course Code: RYD-014
  • Title of the course : Advance Certification in USFDA pharmaceutical and Biopharmaceutical Regulatory Affairs.
  • URL of the course:
  • Duration : 1 Month. Free extendable up to 3 month.
  • Nature of the course: Online distance learning certification course. So, course can be accessed online across anywhere 24×7.
  • Course certification: Certificate will be provided at the end of the successful completion of the course.

Who should attend this course? 

  • Anyone wishing to update their knowledge on US regulatory affairs knowledge for biopharma and biosimilars.
  • Regulatory Affairs, Registration and Documentation assistants, officers or managers.
  • Those who are in regulatory affairs and related department.
  • Likewise, professionals from drug discovery development.
  • Fresher or beginners, Those who want to make a career in drug regulatory department. Therefore, seeking advance understanding on US regulatory affairs.
  • This course is also ideal for the Biopharmaceutical professionals seeking to improve their skills in the US regulatory environment.

Course Features

The participant will be understanding about the US pharmaceutical and biopharmaceutical development to commercialization process in detail. Course is divided into two phases.

Phase 1 – US Pharmaceutical Regulatory Affairs

Phase 1 focuses on the detailed training on US regulatory approval of drugs (chemical small molecules). It covers stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications. Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process.

Phase 2 – US Biopharmaceutical Regulatory Affairs

Phase 2 focuses on the detailed training on US regulatory approval of biopharmaceuticals. Further, the course is divided into innovator biologics regulation and biosimilar regulation. It covers  stages of biologic license application process and approval pathway, biosimilar development and approval pathway.  Course covers fundamentals to advance learning on biomanufacturing, process development, regulation, registration. Above all, the course is specialized on biologic strategic portfolio management.

Other important features to note:

  • Course provides orientation to job related practical aspects of the drug regulatory managers.
  • Simulation to real life working in the regulatory affairs department. It helps to enhance the regulatory strategic decision making.
  • Advance training on drug registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the drug registration steps.

Career in Drug Regulatory Affairs. How US regulatory affairs certification helps?

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The United States pharmaceutical and biopharmaceutical industry is growing at a rapid pace. As far as regulatory is considered, US is considered to be the highly regulated market. Therefore, pharma regulations and laws are changing or getting updated in quick span of time. Hence, it is important for participant to know and update their knowledge periodically.

One more important thing to note here. In recent times there is a rising concern over the safety and efficacy. US regulators even found to be busy auditing plants and lot of 483 observations and warning letters are issued across globe for manufacturing companies. Hence, course participant requires advance training on warning letter, 438 observations.

Lastly, “Data Integrity” is the latest buzz word. Lot of data integrity issues leads to 483s or even warning letters. In fact, more than 30
% of the warning letters are due to data integrity. Regulatory professionals should know what is data integrity and how to handle the data integrity issues.

In conclusion, this US regulatory certification course trains the candidate on not only on drug and biologic registration and regulation, it covers all important recent aspects. For example, course includes how to handle USFDA warning letter, 483 observations, data integrity issues, etc.

About regulatory affairs job>> Learn here

Section 1US - Drug Discovery Development to commercialization Process
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 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8USFDA expedited programs
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation 
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls 
Lecture 16Review on Drug Discovery and Development 
Lecture 17Understanding on Clinical Trials  and Clinical Research 
Lecture 18Clinical Trial Protocol Writing
Lecture 19Ethics in Clinical Research
Lecture 20FDA Forms and How to fill the resources
Lecture 21Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 22Complete Response Letter | Key understanding | Management and Action Plan
Lecture 23Handling of orange book
Lecture 24Purple Book: Significance | Searching | Assignments
Lecture 25Fundamental 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 26Introduction to ICH | Members | Guidelines 
Lecture 27ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 28ICH Q2 : Analytical Validation 
Lecture 29ICH Q3 : Impurities
Lecture 30Rest of ICH Q Family Guidelines
Lecture 31Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
Section 2Regulatory Strategic Planning
Lecture 32Regulatory Strategies in different phases of Clinical Trial
Lecture 33Advance study on Para IV Filing
Lecture 34Para IV Notices
Lecture 35Evergreening - Patent Life Extension Strategies
Lecture 36Pay For Delay Strategy
Lecture 37REMS Strategic Planning 
Lecture 38Compulsory Licensing
Lecture 39Licensing & Technology Transfer
Lecture 40In-Licensing Vs. Outlicensing
Lecture 41LOE Strategies for Innovator Brands with case study
Lecture 42Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 43Drug Repurposing
Lecture 44Practical Queries on different USFDA application and Filing 
Lecture 45New Indication Approval Process and Promotion 
Section 3 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 46Introduction to Common Technical Document (CTD)
Lecture 47CMC Dossier & Compliance Management
Lecture 48Introduction to Electronic Common Technical Document (ECTD)
Lecture 49Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 50Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 51Key Consideration for Drug Master File Preparation and Submission 
Lecture 52Practical Understanding on Drug Master File Preparation and Submission
Lecture 53Site Master File - Detailed Understanding 
Lecture 54DMF Completeness Assessment
Lecture 55Drug Master File - Fees
Lecture 56Drug Master File - Global Perspective [Across Different Regions]
Lecture 57Importance of effective dossier management
Lecture 58Discussion on 85 common deficiencies in CTD submission dossier
Lecture 59Certificate of Analysis
Lecture 60Detailed Understanding on ANDA Submission Dossier 
Lecture 61Prior Approval Submission 
Lecture 62Detailed Understanding on ANDA Fees
Lecture 63Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 64NCE Vs. 505b2 application - Case Based Learning 
Lecture 65FTF - 180 Days Exclusivity - Case Based Learning
Lecture 66Classic case study of the 505b2 filing : Case Based Learning
Lecture 67Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 4GMP and Plant Certification
Lecture 68Certification Pharmaceutical Companies / Plants
Lecture 69G1 Lecture Premises & Plant Layout Designing
Lecture 70G2 Lecture Sanitation and Hygiene
Lecture 71G3 Lecture Equipment Modules
Lecture 72G4 Lecture Production Modules
Lecture 73G5 Lecture Documentation
Lecture 74G6 Lecture Quality Control
Lecture 75G7 Lecture Product Complaint
Lecture 76G8 Lecture Storage Module
Lecture 77Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 78Introduction 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 79WHO-GMP Certification Scheme 
Lecture 80Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 81Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 82Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 83Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 84RTQs | Response to Queries | How to handle Regulatory Queries  
Section 5Post Approval Variation Management
Lecture 85Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 86Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 6BA/BE Study
Lecture 87PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 88Bioequivalence Study | Study design | Different types of BE Studies
Lecture 89Bioequivalence 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 90Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 91Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 92Bioequivalence Study - Discussion - Dissolution Testing
Section 7Biologic Regulatory Affairs - Add on Sessions
Lecture 93Biosimilar Development Process
Lecture 94Strategic Consideration for Biosimilar Development 
Lecture 95Bio-Manufacturing Process Information
Lecture 96Studies required for approval of biosimilar
Lecture 97Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 98Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 99CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)