InstructorRoyed Training
TypeOnline Course
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Price$590 USD / 29500 INR.
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us regulatory affairs course


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USFDA regulatory affairs course

The US regulatory affairs certification training course is to train pharmaceutical, biopharmaceutical regulatory approval process in US. The course provide 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 advance 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 focus on how regulatory professionals work in company and understanding of key responsibilities and job functions.

This is online self-paced modules. Therefore participant can attend the course at it’s own convenient time 24×7.

Course Code: RYD-014

Course Title: Advance Certification in USFDA pharmaceutical and Biopharmaceutical Regulatory Affairs

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

1 Month.

USFDA regulation

Graduation in any discipline.

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.

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

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 focus on the detail 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 focus on the detail training on US regulatory approval of biopharmaceuticals. Further, 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 fundamental to advance learning on biomanufacturing, process development, regulation, registration. Above all, course is containing specialized on biologic strategic portfolio management.

Other important features to note:

  • Course provide orientation to job related practical aspects of the drug regulatory managers.
  • Simulation to real life working in regulatory affairs department. It help 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 7Handling of orange book
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
Section 2Regulatory Strategic Planning
Lecture 25Regulatory Strategies in different phases of Clinical Trial
Lecture 26Advance study on Para IV Filing
Lecture 27Para IV Notices
Lecture 28Evergreening - Patent Life Extension Strategies
Lecture 29Pay For Delay Strategy
Lecture 30REMS Strategic Planning 
Lecture 31Compulsory Licensing
Lecture 32Licensing & Technology Transfer
Lecture 33In-Licensing Vs. Outlicensing
Lecture 34LOE Strategies for Innovator Brands with case study
Lecture 35Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 36Drug Repurposing
Lecture 37Practical Queries on different USFDA application and Filing 
Lecture 38New Indication Approval Process and Promotion 
Section 3 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 39Introduction to Common Technical Document (CTD)
Lecture 40CMC Dossier & Compliance Management
Lecture 41Introduction to Electronic Common Technical Document (ECTD)
Lecture 42Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 43Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 44Key Consideration for Drug Master File Preparation and Submission 
Lecture 45Practical Understanding on Drug Master File Preparation and Submission
Lecture 46Site Master File - Detailed Understanding 
Lecture 47DMF Completeness Assessment
Lecture 48Drug Master File - Fees
Lecture 49Drug Master File - Global Perspective [Across Different Regions]
Lecture 50Importance of effective dossier management
Lecture 51Discussion on 85 common deficiencies in CTD submission dossier
Lecture 52Certificate of Analysis
Lecture 53Detailed Understanding on ANDA Submission Dossier 
Lecture 54Prior Approval Submission 
Lecture 55Detailed Understanding on ANDA Fees
Lecture 56Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 57NCE Vs. 505b2 application - Case Based Learning 
Lecture 58FTF - 180 Days Exclusivity - Case Based Learning
Lecture 59Classic case study of the 505b2 filing : Case Based Learning
Lecture 60Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 4Advance add on learning on US Regulatory Affairs
Lecture 61Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 62Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 63Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 5Post Approval Variation Management
Lecture 64Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 65Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 6BA/BE Study
Lecture 66PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 67Bioequivalence Study | Study design | Different types of BE Studies
Lecture 68Bioequivalence 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 69Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 70Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 71Bioequivalence Study - Discussion - Dissolution Testing