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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.
  • 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 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

     

    REGULATORY AFFAIRS

     

    ENTRY Level  :

    This programme is best for beginners who want to start up their carrier in RA (45 days/20K)

    Topic 1:  Introduction to RA

    Topic 2: ICH guidelines

    Topic 3: CTD – eCTD

    Topic 4: Drug approval procedure in US

    Topic 5: Drug approval procedure in Europe

    Middle Level :

    This programme is best for job aspirants/ working professionals (3months/ 50K)

    Topic 1:  Introduction to RA

    Topic 2: ICH guidelines

    Topic 3: CTD – eCTD

    Topic 4:  Drug Development Process.

    Topic 5: Generic Drugs

    Topic 6: Drug approval procedure in US

    Topic 7: Drug approval procedure in Europe

    Topic 8: Discussion on deficiencies received from authorities and how to address the quires effectively.

    Topic 9: Resume preparation and interview questions.

    Expert Level :

    This programme is best for one who wants to excel in RA profession, ideal for job aspirants/ working professionals (6months/ 75K)

    Topic 1:  Introduction to RA

    Topic 2: ICH guidelines

    Topic 3: CTD – eCTD

    Topic 4:  Drug Development Process and Product development.

    Topic 5: Generic Drugs

    Topic 6: Drug approval procedure in US

    Topic 7: Drug approval procedure in Europe

    Topic 8: Discussion on deficiencies received from authorities and how to address the quires effectively.

    Topic 9: Project work with hands on experience in dossier compilation activity.

    Topic 10: Resume preparation and interview questions.

    Drug approval process in US and EU :

    This programme is best for one who wants to opt for international drug regulatory affairs (6k/ 5hours)

    Topic 1:  Introduction to RA.

    Topic 2: Drug approval procedure in US

    Topic 3: Drug approval procedure in Europe

    Drug substance (API) –  (15K/ 1month):

    Topic 1:  Introduction to RA

    Topic 2: CMC of API

    Topic 3: CTD – eCTD

    Topic 4: Drug substance submission in US

    Topic 5: Drug substance submission in Europe

     

    Dossier/ANDA compilation program (20k/1month):

    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: CTD – eCTD

    • Introduction about CTD/eCTD, origin of CTD and brief description about each section in the modules along with Hands on experience in CTD dossier compilation.
    • Module 1 - Administrative and Prescribing Information
    • Module 2 – Common Technical Document Summaries
    • Module 3 – Quality Part-CMC
    • Module 4 - Nonclinical Study Reports
    • Module 5 - Clinical Study Reports

    Topic 3: Hands on experience in dossier compilation activity.

    • Brief description and extensive discussion about each section in the modules along with compilation activity will taught. 

     

    HR-Interview Etiquettes:-

    • Communication Skill
    • Office etiquettes
    • E-mail etiquettes
    • Presentation skills and Public speaking
    • Interview preparation
    • CV preparation
    • Mock interviews
    • Assessments

     

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.

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