CENTRE FOR DRUG REGULATORY AFFAIRS

The centre commenced in the month of December 2016 with the following objectives:

- Convergence of industry and academia and becoming a think tank on drug regulatory affairs.

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Course:?Certificate Course on Generic Drug Regulations

Organised by:?Centre for Excellence in Drug Regulatory Affairs,

? ? ? ? ? ? ? ? ? ? ? ? ? 沙巴体育?College of Pharmaceutical Sciences, MAHE, 沙巴体育

About the Course:

Drugs are the most regulated commodity. Every stage of the life cycle of the drugs is governed by regulations and often they are country-specific. India supplies generic drugs to more than 80 countries in the world. It is known as the “Pharmacy of the world” for the same reasons. Indian Pharmaceutical industry employs a large number of non-pharmacy professionals who should know basic regulations governing drug development, registration and marketing. This course aims to create that basic understanding in the new professionals who are planning to have a professional career in pharmaceutical, biotechnology and other related fields.

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Scope:?

The course aims at creating an understanding of regulatory submission requirements for a generic drug, especially to USFDA.

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Course Objective:?

1. Understanding the stages of regulatory control.

2. Regulatory forms and procedures of USFDA.

3. Hands-on training in Pharma Ready? an eCTD software.

4. Detailed content and requirements of USFDA form.

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Course Duration:?15 hours

Timings:?09.30 am – 04.00 pm

Dates:?August 7th, August 14th and 28th? 2021 (Following Saturdays)

Credits:?One

Registration:?https://sis.manipal.edu/CertificateCourses.aspx

Last Date:?August 1, 2021

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Click here?to download the brochure for further details.

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Coordinators

Coordinator:?Dr Krishnamurthy Bhat, Professor, Department of Pharmaceutical Quality Assurance, 沙巴体育 College of Pharmaceutical Sciences, 沙巴体育 Academy of Higher Education, 沙巴体育.

Co-coordinator:?Dr Sudheer Moorkoth, Professor and Head, Department of Pharmaceutical Quality Assurance, 沙巴体育 College of Pharmaceutical Sciences, 沙巴体育 Academy of Higher Education, 沙巴体育.

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Contact details

Dr C Mallikarjuna Rao

Professor and Principal

沙巴体育 College of Pharmaceutical Sciences (MCOPS)

沙巴体育 Academy of Higher Education, 沙巴体育 576104

Karnataka State, India

Email: mallik.rao@manipal.edu

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Dr Krishnamurthy Bhat

Professor, Department of Pharmaceutical Quality Assurance

沙巴体育 College of Pharmaceutical Sciences (MCOPS)

沙巴体育 Academy of Higher Education, 沙巴体育 576104

Karnataka State, India

Email: km.bhat@manipal.edu

Phone: 0820 292 2482

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