Comprehensive Program in Regulatory Affairs for Pharmaceutics

Course

Online

₹ 35,000 VAT incl.

Description

  • Type

    Course

  • Level

    Advanced

  • Methodology

    Online

  • Duration

    6 Months

  • Start date

    Different dates available

  • Delivery of study materials

    Yes

  • Support service

    Yes

  • Virtual classes

    Yes

Regulatory Affairs is the area with a broad overview and the responsibility for collecting all data from the development processes and sending it to regulatory authorities where the trained people in regulatory affairs is required.

Facilities

Location

Start date

Online

Start date

Different dates availableEnrolment now open

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.

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

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Reviews

Subjects

  • Regulatory Affairs
  • Regulatory Compliance
  • DRA
  • Pharma
  • Pharmacist
  • Pharmacology
  • Pharmacy Technician
  • Marketing Agency
  • Pharmacy Assistant
  • Pharmaceutical manufacturing

Teachers and trainers (1)

Dr. Shikha Mishra

Dr. Shikha Mishra

Regulatory affairs

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

Comprehensive Program in Regulatory Affairs for Pharmaceutics

₹ 35,000 VAT incl.