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Industry Program in Pharma Regulatory Affairs


Course Overview

The efficacy of a drug varies with the age, body weight, immunity state etc. Thus no drug is completely safe or harmful. However, it is legally as well as morally expected to take appropriate steps should be taken by the producing company to ensure optimal quality, safety and efficacy of the drug. A regulatory affair professional ensures the regulatory compliance in the company and prepares submissions documents for the drugs with the appropriate authorities. This department has to keep pace with the new development in the scientific as well as regulatory rules issuing departments at national and international level. Thus this department is least perturbed by mergers and acquisition and also during recession. Continual education is however, necessary to these professionals.


Course Objectives

The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries and equip them with the educational foundation that will help them advance in the regulatory affairs profession. This program is intended to provide students with a basic understanding of the areas of regulatory affairs and quality operations. It give students a thorough and up-to-date knowledge of federal laws and regulations and their application at various stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products. The legal and regulatory issues are very critical to Pharma companies, Clinical Research Organization and Bio Tech companies. The course focuses on regulatory affairs concept which these organizations must comply to sell their products both domestically and at the international market.


The course has been framed with the following objectives:
  • To give a thorough and up-to-date knowledge of federal laws and regulations as they apply to various stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical devices/products.

  • To create experts in the field of RA documentation and research.

  • To help students build their career in RA and become RA professionals.

  • To provide students with a global knowledge of Regulatory Affairs.

Course Modules:
  • Module I- Pharma Regulation Practices and Procedure

  • Module II- Pharma Patents, IPR and Regulation

  • Module III- Pharma Regulatory Regime in USA, EU and India

  • Module IV- Clinical Trials & Regulation

  • Module V- Good Manufacturing Practices, Quality Assurance and Regulation

  • Module VI- Regulatory Compliance for Pharma and Biotech Products

  • Research Study

Examination Fees

Every student has to pay Rs.500/- per module as examination fees. Examination fee for overseas participants is USD 30 Per Module


Download The Examination Form
Career Opportunities

The program equips students with the understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products at national and international level. This specialized knowledge enables regulatory affair professionals to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The students after completion of the course work as

  • Pharma Regulatory Affairs Consultant

  • Regulatory Officer

Eligibility: Any Science Graduate


Program Fee

BII Program Participation Fee for this program is Rs 10,500 for participants based in India (USD 750 for overseas participants). At the end of the duration of a program, participants go through a well defined evaluation process which is held on all India basis.


Download The Application Form

For further details and enquiries

Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail:info@bii.in

Global Students for any queries

E-mail: global@bii.in, info@bii.in

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