Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]

4.0
1 opinion
  • Course is helpful to get DRA entry level job
    |

Course

Distance

₹ 14,500 VAT incl.

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Description

  • Type

    Course

  • Level

    Advanced

  • Methodology

    Distance learning

  • Duration

    12 Months

  • Start date

    Different dates available

  • Delivery of study materials

    Yes

  • Support service

    Yes

  • Examinations- physical attendance required

    Yes

This course will help them understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of Regulatory affairs. The objectives of the course are: To create experts in the field of RA documentation and research. To encourage continuous learning and development in RA field. To update knowledge of existing RA professionals.
Suitable for: B Pharmacy/ M Pharmacy/ Science Graduate with working Experience

Facilities

Location

Start date

Distance learning

Start date

Different dates availableNow taking bookings

About this course

The courses will provide integrated knowledge and broad perspectives you need to effectively manage the regulatory process from Innovation →Discovery → Approval→ Commercialization which implies regulatory affairs are essential to bring the product to the market globally. To gain the essential knowledge and skills required to help companies to work in regulatory environment. To acquire the foundation to work within or in variety of areas including medical products development, pharmaceutical formulations, sales, strategic marketing and clinical investigations. To know about regulatory process in drug development, formulations, API. To sharpen the understanding of the laws that governs the development, manufacturing and commercialization along with the distribution of drugs, biologics and medical devices.

This course is aimed at participants who want to join Regulatory Affairs as career.

Post Graduate in Life-science or Pharma OR Graduate in Life-science with work experience in similar domain.

Post Graduate in Life-science or Pharma OR Graduate in Life-science with work experience in similar domain.

This program will upgrade you to enter or promote in Regulatory Affairs domain.

After receiving your request our team member will contact you and mail you all related information.

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Opinions

4.0
  • Course is helpful to get DRA entry level job
    |
100%
4.3
fantastic

Course rating

Recommended

Centre rating

Anjukrishna S R

4.0
07/02/2020
About the course: Course is helpful to get DRA entry level job
Would you recommend this course?: Yes
Reviews gathered by Emagister & iAgora

Subjects

  • Regulatory Compliance
    1

    1 students say they acquired this skill

  • Regulatory Affairs
    1

    1 students say they acquired this skill

  • DRA
    1

    1 students say they acquired this skill

  • FDRA
    1

    1 students say they acquired this skill

  • RA
    1

    1 students say they acquired this skill

  • DMF
    1

    1 students say they acquired this skill

  • Dossier
    1

    1 students say they acquired this skill

  • Pharma Regulatory Affairs
    1

    1 students say they acquired this skill

  • Regulatory Compliances and Affairs
    1

    1 students say they acquired this skill

  • Drug Safety
    1

    1 students say they acquired this skill

  • Drug Laws
    1

    1 students say they acquired this skill

Teachers and trainers (3)

Dr Abhinav Srivastava

Dr Abhinav Srivastava

Biotechnology

Dr. Kumud  Sarin

Dr. Kumud Sarin

Technical Head

Mr. Ajay  Viswakarma

Mr. Ajay Viswakarma

Bioinformatics

Course programme

Here is the course papers
Paper-I:
Introduction to Regulatory Affairs and Profession
Paper-II:
International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
Paper-IV: Global Regulatory Compliance Systems
Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines
Paper-VI: Regulatory Strategy and Quality Assurance Systems
Paper-VII: Future of Biopharmaceuticals
Paper-VIII: Research Study

Call the centre

Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]

₹ 14,500 VAT incl.