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Drug Regulatory Affairs (US & EU)

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

Why this course ?

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real Time 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. 
  • Lifetime Access

    You can get lifetime availability of class recordings and presentations can be shared with you, you can download and Stored in your system.
  • 24/7 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
  • International Drug Regulatory Affairs

    Topic 1:  Introduction to RA:
    What is Regulatory Affairs, Importance of RA department, Roles and their functions, and Worldwide regulatory agencies
    General overview of the Pharmaceutical Industry, role of various departments and their functioning.

    Topic 2: Drug approval procedure in US:
    US(FDA) Introduction, 21CFR, INDA, NDA, ANDA drug applications, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements) and Types of DMF’s.

    Topic 3: Drug approval procedure in Europe:
    Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions) and approval procedures for drug substance (DMF and CEP).

Projects

  • Real time projects on Regulatory Affairs

    Covalent Provides Realtime projects working on Documentation process, Dossier preparation, CTD, e-CTD, ICH, GCP, MHRA Guidelance.

    Working on National and International Regulations.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session.

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    Yes

  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Malk interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real time projects
    Working faculties 
    Lab facilities
    Placement assistance
    Resume preparation
    Software installation
    Doughts Clarification & Job Support.

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course.

Videos

RA Demo (US & EU)

Reviews

Sunitha Sivadanam

Fresher

Hi this is Sunitha, from Hyderabad. I am thankful to covalent for showing placements in Hetero Pharma. a best training place for International Drug Regulatory Affairs Training.

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