Indian Regulatory System

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Course Code: IRS201904
Courses Name: Indian Regulatory System
Name of HOD – Rajendra Dobriyal
Designation of HOD – Director – Scientific & Regulatory Affairs Coca Cola India the Coca-Cola Company

About the course : Indian Regulatory affairs professionals are in high demand and the career opportunities in the area of Indian Regulatory Affairs are phenomenal. This program will provide you a thorough understanding of various regulatory rules of Indian Regulatory Affairs; investigational and new drug applications; regulatory strategies and various other concepts. The Regulatory Affairs program provides professionals with the focused knowledge required to help biotechnology, medical device, pharmaceutical, nutraceuticals and food companies manage regulatory processes. The Regulatory Affairs Training provided by Nutrify Today Academy would make possible the participants with the understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of laws and regulations as they apply to all stages of the improvement and commercialization of Pharmaceutical, Nutraceuticals, Food Technology.

Course Status :	Admissions open
No. of Modules	10
Course Type :	Elective
Duration :	–
Category :	Food Technology, Pharmaceuticals and Nutraceuticals
Credit Points :	2
Level :	Postgraduate/ Undergraduate

Marketing
Highlights the New laws and regulations in the industry
Drug Regulations
Drug Discovery
Awareness of the regulatory requirements and guidelines

Week 1	Introduction to Regulatory Authorities and applicable Regulations for healthcare industry Public Health, Standardization, Consumer Protection, Trade promotion.
Week 2	Licensing related norms and regulations Objective of a License/ Registration certificate Concept of FSSAI License, Central & State Licensing
Week 3	GMP and other good practices Establishment – Maintenance & Sanitation Control of Operations Product Information & Labelling GMP Training & Management Consumer awareness and Complaint handling Audit, Documentation & Record keeping
Week 4	Documentation related to existing products and regulatory filings in India for Novel food/ingredients, etc. Food Legislation & FSSA Objectives Risk Management Procedure for grant of Prior Approval
Week 5	Quality Assurance related Regulations Food safety and quality assurance Learning in pilot plant facility
Week 6	Regulation related to labeling and Display of products Objectives of Labelling Food Products Regulations applicable for Labelling the food products Food Safety and Standards ( Labelling & Display Regulations) Food Safety and Standards ( Advertising and Claims Regulations) Label Metrology (Packaged Commodities Rules)
Week 7	Healthcare Industry IPR, Patents, copyrights and Trademarks Patenting of products Types of Specification, What Information Patent Document Includes, Understanding Claims Patent Granting Procedure, Other Important Provisions, Copyright, Trademark
Week 8	Healthcare products- Marketing, Import and Export regulations Introduction to Nutraceuticals and Health Supplements Product Categorizing and regulations applicable Food Safety and Standards Import regulations from other countries Mandatory documents requirements for Imports & Exports Product Labelling, Restrictions requirements Marketing modes of the products, E – Commerce & Retail sale requirements
Week 9	Compliance guidelines, Govt. Audits (Fssai, 3rd party etc) Concept of regulatory compliance & enforcement. Types of food regulatory compliances. Understanding food product testing requirements. Regulations governing food product testing, Testing requirements of “Proprietary foods”. Choosing Food laboratory & Understanding food analysis report.
Week 10	Intro of AYUSH Food Regulation including and Ayush Food Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy) About Nutraceuticals Nutraceuticals Regulations Ayush Aahar under FSSAI Ayush Foods ( Medicines) under Ayush

What is the admissions process for the programme?

The admissions process is completely online and is customised as per your educational and professional profile. Following are the key steps in the application process:

Step 1: Register yourself on to Nutrify Today platform by clicking on https://nutrifytoday.net/ and create your individual profile, building your CV onto the platform.
Step 2: Select up skill > Academy > Master classes
Step 3: Select the course and make the payment, receive immediate access to the prep content and begin your Nutrify Today Academy journey.

Benefits:

100% online
This Course Plus the Full Specialization
Shareable Certificates
Self-Paced Learning Option
Course Videos & Readings

Intended audience : Any current Masters pursing students or potential professionals in Pharmaceuticals, Nutraceuticals, MBA in Marketing, Sales.

Criteria to get the Certificate : Exam score = 80% of the proctored certification exam score out of 100

Certificate will have your name, photograph and the score in the final exam with the breakup
Only the e-certificate will be made available. Hard copies will not be dispatched.

Internship opportunities and Nutrify Today industrial connects for job opportunities in the field of R & D, Regulatory, and Manufacturing departments of Nutraceuticals, Pharmaceuticals and Food Technology.