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Industry Program in Pharma Regulatory Affairs

Distance Learning by Bioinformatics Institute of India (BII)

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On-Site / Short Course

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NOIDA H-109, SECTOR-63, NOIDA, Noida, Uttar Pradesh, India 201307

INR 10,500.00

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Aim and Objectives

Aim and Objectives:

The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to equip them with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

Course Modules: been framed with the following objectives

To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device 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.
Pharma Regulation Practices and Procedure
Pharma Patents, IPR and Regulation
Pharma Regulatory Regime in USA, EU and India
Clinical Trials & Regulation
Good Manufacturing Practices, Quality Assurance and Regulation
Regulatory Compliance for Pharma and Biotech Products
Research Study

Eligibility::
Any Science Graduate

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Established in 2002, Bioinformatics Institute of India (BII) is first of its kind with solely focusing on Bioinformatics and other applied life sciences courses.

BII is, resolute visionary, committed to provide world class technical and scientific education in life sciences courses. The aim behind the establishment of BII was to synergize theoretical knowledge and practical skills to promote all round professional competence due to which now BII has acquired a unique status in the country and globally.

Bioinformatics Institute of India (BII), set-up in the year 2002 has acquired international reputation by conducting industry oriented knowledge enhancement programs in the emerging domains of life science.Within a short span of a decade, BII has traversed many milestones in academic excellence and is today recognized as premier institute for providing the training in the area of Bioinformatics, Biotechnology, Pharmacy and Life Sciences.

The course-curriculum has been designed on global industrial pattern to fill the gap between academia and industry has lead BII to attain professional expertise in the field of life science and its allied area.

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