InstructorRoyed Training
TypeOnline Course
Price$390 / 22500 INR.
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Drug registration in India

Introduction

Course Type

Course Duration

Eligibility

Who should attend

Certification

Features

Related Courses

About CDSCO Drug Registration Process

cdsco drug registration

This online certification course provides hands-on training on drug registration and strategic planning process in India. In other words, it covers the entire drug regulatory affairs in India. In fact, this course provides comprehensive training on how to carry out the marketing authorization process and various strategic planning associated with that. Moreover, the course covers recent regulations, marketing authorization procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover the course focus on the regulatory affairs strategic planning for marketing authorization for different classes of pharmaceutical, biopharmaceuticals in India. Hence, this course is vastly useful for those who want to know or are already working in regulatory affairs. This course will help them to enhance competency to handle CDSCO working effectively.

The course is an essential source of information on import and export of pharmaceuticals in India. Moreover the course identifies the key trends in regulatory, pricing landscape and market access planning. Most importantly, the course provides valuable insights and advanced regulatory strategic planning for successful product registration in India.

The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place, allowing the user to stop and start at their leisure.

Course Code: RYD-104

Course Title: Advanced Certification in Drug Registration in India (ACDRI)

Online micro learning course. So, course can be accessed online across anywhere 24×7.

Course duration is 1 month. However, one can complete the course within one month anytime.

Any body who wants to acquire detailed understanding of the drug registration and regulation in India.

Any body who wants to acquire competency regarding new drug development process, should attend the course.

Who should attend this course? 

  • This course is ideal for those who requires detailed pharmaceutical import and export.
  • Most importantly this course is ideal for the regulatory, strategic management and international marketing professionals who are handling drug import and export from India.
  • Fresher/Beginners, Those who want to make a career in pharmaceutical international business.
  • Moreover, this Bioavailability and Bioequivalence study will be ideal for R&D managers, Regulatory Affairs Executives and Managers, Formulation managers, Production Manager, International Business Manager etc.

Certificate will be provided at the end of the successful completion of the course

  • Pharmaceutical Regulations in India.
  • Understanding on how to register various types of the drug products with CDSCO.
  • Import and export procedure.
  • How to handle pharma export.
  • WHO-GMP certification Scheme.
  • Drug dossier preparation for drug registration in India.
  • Detailed understanding of CPP.
  • Significance and importance of Certification of Pharmaceutical Product.
  • Different types of CPP.
  • Format of CPP. Different section – how to work on CPP.
  • USFDA CPPs.
  • FSC and CPP difference.
  • CPP Scheme for generic submission.
  • Plant inspection as a part of CPP scheme.
  • Case discussion.
  • Country and regions who requires CPP.

Drug Registration in India has changed and updated in recent years. CDSCO, the principal drug regulatory agency in India has updated guidelines to make the approval process more effective. However, the timing of these structural changes coincide with India’s growing demand for newer classes of drugs as well as their increasing ability to afford international prices. Although recently developed foreign drugs are now increasingly able to take advantage of India’s drug demand growth, the Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing.

In this course we are going to discuss about the entire drug registration process in India.

Section 1
Lecture 1Drug Registration and Regulation in India - Prime Session | CDSCO - Organization Regulatory Functions - Central and State | Import License | Registration Certificate | Inspection, Fees and Process | Export from India | Step by Step Guidance
Lecture 2Medicine Export Criteria from India
Lecture 3New Drug Approval in DCGI
Lecture 4Line Extension New Strength Approval
Lecture 5Line Extension - New Indication Approval
Lecture 6Generic Process Post Submission
Lecture 7Post Approval CMC Changes
Lecture 8Post Approval PI changes
Lecture 9Subsequent New Drug Approval
Lecture 10Documents for conducting BE Study for Export