Drug Regulatory Affairs

Course Features

• Instructor Live Sessions

  There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  
• Real-time Case Studies

  Live project based on any of the selected use cases on the above selected Domain. 
  
• Assignments

  Each class will be followed by practical assignments which can be completed before the next class.
  
• 24 x 7 Expert Support

  We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  
• Certification

  Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.
  

Course Curriculum

• Regulatory affairs

  Course Topics

  • ICH Guidelines
  • SUPAC Guidelines
  • Regulatory Guidelines
  • Regulatory Submission

                USFDA

                EMEA

                Indian (Domestic) 

  • Preparing response to Deficiencies
  • DMF’s

   

  Part I

  1. ICH GUIDELINES 

  2. SUPAC GUIDELINES 

  3. INTRODUCTION AND GENERAL OVERVIEW OF PHARMACEUTICAL INDUSTRY 

  • Functions and types of DOSAGE Forms
  • Definitions and various departments in an industry
  • RA as a Profession and its Importance
  • Code of ethics of regulatory profession
  • Functions of RA
  • Importance of QA and its Link with RA.
  • Origin of drug development process and filings

   

  Part II

  1. REGULATORY SUBMISSION 

            USFDA

  • Drug Firm Establishment Registration with US-FDA (FEI No.)
  • NDC No. and DUNS
  • Generic Drug Submission
  • Preparation, Review and Submission of Application to USFDA.
  • Technical Support in CMC-Writing
  • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR
  • Manufacturing Formula and Process
  • Preparation of Labels and Pack Insert
  • Consulting and preparation of all modules (M-1, M-2, M-3, M-5) for registration purpose in any country as per latest country specific guidelines.
    • Review, evaluation and Gap Analysis for compiled dossiers
    • Respond to deficiencies raised by regulatory authorities

           

             EMEA

  • EU Commission
  • Procedures
  • Guidelines and Eudralex
  • Gap Analysis
  • Dossier writing for MAA
  • Preparation of SmPC, PIL
  • Responses to deficiencies.
  • Life Cycle management

   

  Part III

  Indian Regulatory Filing and Emerging markets

  • Dossier preparation
  • ICH CTD, ASEAN CTD and Country specific formats.
  • Prepare documents for company registrations in various countries.
  • Review, evaluation and gap analysis for compiled dossiers.
  • Renewal of registrations.
  • Prepare documents to file variations in case of Approved/Registered products.
  • Arrange GMP inspections
  • Preparation of SMF
  • Quality overall summary
  • Technical Support in CMC-Writing
  • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR
  • Manufacturing Formula and Process
  • Preparation of Labels and Pack Insert
  • Review, evaluation and gap analysis for compile dossiers.
  • Respond to deficiencies raised by regulatory authorities.

   

  Part IV

  1. DMF

  • Introduction of DMF’s
  • DMF process
  • DMF Formats
  • DMF contents
  • Difference between US and Europe DMF’s

   

  Highlights

  • Critical Review of Dossier and Preparation of GAP Analysis Report
  • Re-formatting old Dossier/DMF, NTA to CTD/eCTD format
  • Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
  • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula and Process
  • Handling deficiencies
  • Life Cycle Management

   

Projects

• Drug Regulatory Affairs Project

  Hands on workshops in next 15 days:

  • Word template of CTD structure.
  • Hands on work of filling different regulatory forms in US/EU/India.
  • Preparing for Regulatory interviews (Example interview questions will be provided).

FAQ's

• Can I attend a demo session before enrolment?

  Yes

• What if I miss a class ?

  If you miss a class we can give backup calss for particular session and same session you have to attend another batch also

• Will I get placement Assistance ?

  yes

• Do I receive a certificate for training ?

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs.

• what support is available after the training?

  Doubts clarification up to getting a job

  Resume preparation

  Mock interviews

  Placement Assistance

• What Features do you provide?

  • Led sessions with corporate trainers
  • Course Material
  • Real-time projects with industry experts
  • Day wise Assignments (Tasks)
  • Placement assistance
  • Resume preparation
  • Doubts  clarifications

Certifications

• Course Completion Certificate

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs.