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Drug Regulatory Affairs

Regulatory affairs (RA), also called government affairs. The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Why this course ?

Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.

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

Download
  • 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 
    1. SUPAC GUIDELINES 
    1. 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.

Videos

Videos

Reviews

Gowthami

Fresher

Best Drug Regulatory Affairs program from Covalent, helped me to get a breakthrough in the pharma industry with Regulatory affairs as my forte. 

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Neelima K

Drug Safety Associate

Teaching staff is experienced and from top most pharma industry. All doubts and queries are clarified during session. Faculty is also very good and cooperative. Notes provided are easy to understand. More focus on current updates in pharma industry explained with examples and also with sharing their experiences.

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Divya Sama

Drug Safety Associate

The classes and the practices they gives are quite worthy. Also faculties have the perfect way of guidance to the students and that is notable one. I strongly recommend this institute for doing courses like some other medical related courses like Drug Regulatory Affairs.

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S. PAVANI

Drug Safety Associates

Wish my friends and health care professionals a very Happy international clinical trials day. Before joining in the Covalent i am very confused which profession have to choose but when i come to know about Covalent felt it is very best institute for pv ,clinical research, CDM. I suggest my friends to join in Covalent institute and also improve your communication skills. Thank you Covalent.

readmore...

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