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rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches
SEMESTER II
REGULATORY ASPECTS OF DRUGS & COSMETICS (MRA 201T)
Scope
This course is designed to impart the fundamental knowledge on the drug development process, regulatory requirements for approval of new drugs, drug products and cosmetics in regulated and semi-regulated countriesIt prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products and cosmetics in regulated and semi-regulated countries.
Objectives
Upon completion of the course, the student shall be able to know
process of drug discovery and development and generic product development
regulatory approval process and registration procedures for API and drug products in US, EU
Cosmetics regulations in regulated and semi-regulated countries
A comparative study of India with other global regulated markets
Theory 60 Hrs
1. USA & CANADA: Organization structure and functions of FDA. Federal register and Code of Federal Regulations (CFR), History and evolution of United States Federal, Food, Drug and Cosmetic Act (FFDCA), Hatch Waxman act and Orange book, Purple book, Drug Master Files (DMF) system in US, Regulatory Approval Process for Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New Drug Application (SNDA); Regulatory requirements for Orphan drugs and Combination Products, Changes to an approved NDA / ANDA. Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in USA. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in USA and Canada.
European Union & Australia: Organization and structure of EMA & EDQM, General guidelines, Active Substance Master Files (ASMF) system in EU, Content and approval process of IMPD, Marketing Authorization procedures in EU (Centralized procedure,
12
Hrs
12
Hrs
Decentralized procedure, Mutual recognition procedure and National Procedure). Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in EU, Eudralex directives for human medicines, Variations & extensions, Compliance of European Pharmacopoeia (CEP)/ Certificate of Suitability (CoS), Marketing Authorization (MA) transfers, Qualified Person (QP) in EU. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in European Union & Australia.
Japan: Organization of the PMDA, Pharmaceutical Laws and regulations, types of registration applications, DMF system in Japan, drug regulatory approval process, Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in Japan, Post marketing surveillance in Japan. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in Japan
Emerging Market: Introduction, Countries covered, Study of the world map,study of various committees across the globe (ASEAN, APEC, EAC, GCC, PANDRH, SADC)
WHO: WHO, GMP, Regulatory Requirements for registration of drugs and post approval requirements in WHO through prequalification programme, Certificate of Pharmaceutical Product (CoPP) - General and Country Specific (South Africa, Egypt, Algeria and Morocco, Nigeria, Kenya and Botswana)
Brazil, ASEAN, CIS and GCC Countries:
ASIAN Countries: Introduction to ACTD, Regulatory
Requirements for registration of drugs and post approval requirements in China and South Korea & Association of Southeast Asian Nations (ASEAN) Region i.e. Vietnam, Malaysia, Philippines, Singapore and Thailand.
CIS (Commonwealth Independent States): Regulatory pre- requisites related to Marketing authorization requirements for drugs and post approval requirements in CIS countries i.e. Russia, Kazakhstan and Ukraine GCC (Gulf Cooperation Council) for Arab states: Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia and UAE
Legislation and regulations for import, manufacture, distribution and sale of cosmetics in Brazil, ASEAN, CIS and GCC Countries.
12
Hrs
12
Hrs
12
Hrs
REFERENCES :
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker Series, Vol.144
The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol.185 Informa Health care Publishers.
New Drug Approval Process: Accelerating Global Registrations By
th
Richard A Guarino, MD, 5 edition, Drugs and the Pharmaceutical Sciences, Vol.190.
Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
Drugs: From Discovery to Approval, Second Edition By Rick Ng
New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu
Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines and Gary H. Slatko
Preparation and Maintenance of the IND Application in eCTD Format By William K. Sietsema
Country Specific Guidelines from official websites.
ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN 978-981-230-750-7
Building a Future with Brics: The Next Decade for Offshoring, Mark Kobayashi-Hillary, Springer
Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary, Springer Trade performance and Regional Integration of the CIS Countries, Lev Freinkman,
The world Bank, Washington, DC, ISBN: 0-8212-5896-0
Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World ByFrederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes 139
The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by Linda Low and Lorraine Carlos Salazar (Nov 22, 2010)
Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press ISBN:13:978-1-60649-108-9
Realizing the ASEAN Economic Community: A Comprehensive Assessment, Michael G Plummer (Editor), Chia Siow Yue (Editor), Instute of South east asian studies, Singapore
REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS
(MRA 202T)
Scope
This course is designed to impart fundamental knowledge on Regulatory Requirements, Licensing and Registration, Regulation on Labelling of Biologics in India, USA and Europe
It prepares the students to learn in detail on Regulatory Requirements for
biologics, Vaccines and Blood Products
Objectives
Upon the completion of the course the student shall be able to :
Know the regulatory Requirements for Biologics and Vaccines
Understand the regulation for newly developed biologics and biosimilars
Know the pre-clinical and clinical development considerations of biologics
Understand the Regulatory Requirements of Blood and/or Its
Components Including Blood Products and label requirements
Theory 60 Hrs
1. India : Introduction, Applicable Regulations and Guidelines , Principles for Development of Similar Biologics, Data Requirements for Preclinical Studies, Data Requirements for Clinical Trial Application, Data Requirements for Market Authorization Application, Post-Market Data for Similar Biologics, Pharmacovigilance. GMP and GDP.
USA: Introduction to Biologics; biologics, biological and biosimilars, different biological products, difference between generic drug and biosimilars, laws, regulations and guidance on biologics/ biosimilars, development and approval of biologics and biosimilars (IND, PMA, BLA, NDA, 510(k), pre-clinical and clinical development considerations, advertising, labelling and packing of biologics
European Union: Introduction to Biologics; directives, scientific guidelines and guidance related to biologics in EU, comparability/ biosimilarity assessment, Plasma master file, TSE/ BSE evaluation, development and regulatory approval of biologics (Investigational medicinal products and biosimilars), pre-clinical
12
Hrs
12
Hrs
12
Hrs
and clinical development considerations; stability, safety, advertising, labelling and packing of biologics in EU
Vaccine regulations in India, US and European Union: Clinical evaluation, Marketing authorisation, Registration or licensing, Quality assessment, Pharmacovigilance, Additional requirements Blood and Blood Products Regulations in India, US and European Union: Regulatory Requirements of Blood and/or Its Components Including Blood Products, Label Requirements, ISBT (International Society of Blood Transfusion) and IHN (International Haemovigilence Network)
Herbal Products: Quality, safety and legislation for herbal products in India, USA and European Union.
12
Hrs
12
Hrs
REFERENCES
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Douglas J. Pisano , David S. Mantus ; Informa ,2008
Biological Drug Products: Development and Strategies; Wei Wang , Manmohan Singh ; wiley ,2013
Development of Vaccines: From Discovery to Clinical Testing; Manmohan Singh , Indresh K. Srivastava ;Wiley, 2011
This course is designed to impart the fundamental knowledge on the medical devices and in vitro diagnostics, basis of classification and product life cycle of medical devices, regulatory requirements for approval of medical devices in regulated countries like US, EU and Asian countries along with WHO regulations. It prepares the students to learn in detail on the harmonization initiatives, quality and ethical considerations, regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Objectives
Upon completion of the course, the student shall be able to know
basics of medical devices and IVDs, process of development, ethical and quality considerations
harmonization initiatives for approval and marketing of medical devices and IVDs
regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN
clinical evaluation and investigation of medical devices and IVDs
Theory 60 Hrs
1. Medical Devices: Introduction, Definition, Risk based classification and Essential Principles of Medical Devices and IVDs. Differentiating medical devices IVDs and Combination Products from that of pharmaceuticals, History of Medical Device Regulation, Product Lifecycle of Medical Devices and Classification of Medical Devices.
and Functions, Regulatory Guidelines, Working Groups, Summary Technical Document (STED), Global Medical Device Nomenclature (GMDN).
Ethics: Clinical Investigation of Medical Devices, Clinical Investigation Plan for Medical Devices, Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011) Quality: Quality System Regulations of Medical Devices: ISO 13485, Quality Risk Management of Medical Devices: ISO 14971, Validation and Verification of Medical device, Adverse Event Reporting of Medical device
12
Hrs
12
Hrs
USA: Introduction, Classification, Regulatory approval process for Medical Devices (510k) Premarket Notification, Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and In vitro Diagnostics, Quality System Requirements 21 CFR Part 820, Labeling requirements 21 CFR Part 801, Post marketing surveillance of MD and Unique Device Identification (UDI). Basics of In vitro diagnostics, classification and approval process.
European Union: Introduction, Classification, Regulatory approval process for Medical Devices
(Medical Device Directive, Active Implantable Medical Device Directive) and In vitro Diagnostics (In Vitro Diagnostics Directive), CE certification process.
Basics of In vitro diagnostics, classification and approval process.
ASEAN, China & Japan: Medical Devices and IVDs, Regulatory registration procedures, Quality System requirements and clinical evaluation and investigation.
IMDRF study groups and guidance documents.
12
Hrs
12
Hrs
12
Hrs
REFERENCES
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics by Douglas J. Pisano, David Mantus.
Medical Device Development: A Regulatory Overview by Jonathan S.
Kahan
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin and Gary Walsh
Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by Carmen Medina
Country Specific Guidelines from official websites.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS (MRA 204T)
Scope
This course is designed to impart the fundamental knowledge on Regulatory Requirements, Registration and Labeling Regulations of Nutraceuticals in India, USA and Europe.
It prepares the students to learn in detail on Regulatory Aspects for
nutraceuticals and food supplements.
Objectives
Upon completion of the course, the student shall be able to
Know the regulatory Requirements for nutraceuticals
Understand the regulation for registration and labeling of nutraceuticals and food supplements in India, USA and Europe.
Theory 60 Hrs
1. Nutraceuticals: Introduction, History of Food and Nutraceutical Regulations, Meaning of Nutraceuticals, Dietary Supplements, Functional Foods, Medical Foods, Scope and Opportunities in Nutraceutical Market.
Global Aspects: WHO guidelines on nutrition. NSF International: Its Role in the Dietary Supplements and Nutraceuticals Industries, NSF Certification, NSF Standards for Food And Dietary Supplements. Good Manufacturing Practices for Nutraceuticals.
India : Food Safety and Standards Act, Food Safety and Standards Authority of India: Organization and Functions, Regulations for import, manufacture and sale of nutraceutical products in India, Recommended Dietary Allowances (RDA) in India.
USA: US FDA Food Safety Modernization Act, Dietary Supplement Health and Education Act. U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements, Labelling Requirements and Label Claims for Dietary Supplements, Recommended Dietary Allowances (RDA) in the U.S
12
Hrs
12
Hrs
12
Hrs
12
Hrs
European Union: European Food Safety Authority (EFSA): Organization and Functions. EU Directives and regulations for manufacture and sale of nutraceuticals and dietary supplements. Nutrition labelling. European Regulation on Novel Foods and Novel Food Ingredients. Recommended Dietary Allowances (RDA) in Europe.
12
Hrs
REFERENCES
Regulation of Functional Foods and Nutraceuticals: A Global Perspective by Clare M. Hasler (Wiley Online Library)
Nutraceutical and Functional Food Regulations in the United States and Around the World by Debasis Bagchi (Academic Press, Elsevier)
Handbook of Nutraceuticals by Yashwant Pathak (CRC Press)
Food Regulation: Law, Science, Policy and Practice by Neal D. Fortin (Wiley)
Country Specific Guidelines from official websites.
REGULATORY AFFAIRS PRACTICAL - II (MRA 205P)
Case studies on
Change Management/ Change control. Deviations
Corrective & Preventive Actions (CAPA)
Documentation of raw materials analysis as per official monographs
Preparation of audit checklist for various agencies
Preparation of submission to FDA using eCTD software
Preparation of submission to EMA using eCTD software
Preparation of submission to MHRA using eCTD software
Preparation of Biologics License Applications (BLA)
Preparation of documents required for Vaccine Product Approval
Comparison of clinical trial application requirements of US, EU and India of Biologics
Preparation of Checklist for Registration of Blood and Blood Products
Registration requirement comparison study in 5 emerging markets (WHO) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (BRICS) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (China and South Korea) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (ASEAN) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (GCC) and preparing check list for market authorization
Checklists for 510k and PMA for US market
Checklist for CE marking for various classes of devices for EU
STED Application for Class III Devices
Audit Checklist for Medical Device Facility
Clinical Investigation Plan for Medical Devices
=======
rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches
SEMESTER II
REGULATORY ASPECTS OF DRUGS & COSMETICS (MRA 201T)
Scope
This course is designed to impart the fundamental knowledge on the drug development process, regulatory requirements for approval of new drugs, drug products and cosmetics in regulated and semi-regulated countriesIt prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products and cosmetics in regulated and semi-regulated countries.
Objectives
Upon completion of the course, the student shall be able to know
process of drug discovery and development and generic product development
regulatory approval process and registration procedures for API and drug products in US, EU
Cosmetics regulations in regulated and semi-regulated countries
A comparative study of India with other global regulated markets
Theory 60 Hrs
1. USA & CANADA: Organization structure and functions of FDA. Federal register and Code of Federal Regulations (CFR), History and evolution of United States Federal, Food, Drug and Cosmetic Act (FFDCA), Hatch Waxman act and Orange book, Purple book, Drug Master Files (DMF) system in US, Regulatory Approval Process for Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New Drug Application (SNDA); Regulatory requirements for Orphan drugs and Combination Products, Changes to an approved NDA / ANDA. Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in USA. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in USA and Canada.
European Union & Australia: Organization and structure of EMA & EDQM, General guidelines, Active Substance Master Files (ASMF) system in EU, Content and approval process of IMPD, Marketing Authorization procedures in EU (Centralized procedure,
12
Hrs
12
Hrs
Decentralized procedure, Mutual recognition procedure and National Procedure). Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in EU, Eudralex directives for human medicines, Variations & extensions, Compliance of European Pharmacopoeia (CEP)/ Certificate of Suitability (CoS), Marketing Authorization (MA) transfers, Qualified Person (QP) in EU. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in European Union & Australia.
Japan: Organization of the PMDA, Pharmaceutical Laws and regulations, types of registration applications, DMF system in Japan, drug regulatory approval process, Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in Japan, Post marketing surveillance in Japan. Legislation and regulations for import, manufacture, distribution and sale of cosmetics in Japan
Emerging Market: Introduction, Countries covered, Study of the world map,study of various committees across the globe (ASEAN, APEC, EAC, GCC, PANDRH, SADC)
WHO: WHO, GMP, Regulatory Requirements for registration of drugs and post approval requirements in WHO through prequalification programme, Certificate of Pharmaceutical Product (CoPP) - General and Country Specific (South Africa, Egypt, Algeria and Morocco, Nigeria, Kenya and Botswana)
Brazil, ASEAN, CIS and GCC Countries:
ASIAN Countries: Introduction to ACTD, Regulatory
Requirements for registration of drugs and post approval requirements in China and South Korea & Association of Southeast Asian Nations (ASEAN) Region i.e. Vietnam, Malaysia, Philippines, Singapore and Thailand.
CIS (Commonwealth Independent States): Regulatory pre- requisites related to Marketing authorization requirements for drugs and post approval requirements in CIS countries i.e. Russia, Kazakhstan and Ukraine GCC (Gulf Cooperation Council) for Arab states: Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia and UAE
Legislation and regulations for import, manufacture, distribution and sale of cosmetics in Brazil, ASEAN, CIS and GCC Countries.
12
Hrs
12
Hrs
12
Hrs
REFERENCES :
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker Series, Vol.144
The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol.185 Informa Health care Publishers.
New Drug Approval Process: Accelerating Global Registrations By
th
Richard A Guarino, MD, 5 edition, Drugs and the Pharmaceutical Sciences, Vol.190.
Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
Drugs: From Discovery to Approval, Second Edition By Rick Ng
New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu
Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines and Gary H. Slatko
Preparation and Maintenance of the IND Application in eCTD Format By William K. Sietsema
Country Specific Guidelines from official websites.
ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN 978-981-230-750-7
Building a Future with Brics: The Next Decade for Offshoring, Mark Kobayashi-Hillary, Springer
Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary, Springer Trade performance and Regional Integration of the CIS Countries, Lev Freinkman,
The world Bank, Washington, DC, ISBN: 0-8212-5896-0
Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World ByFrederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes 139
The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by Linda Low and Lorraine Carlos Salazar (Nov 22, 2010)
Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press ISBN:13:978-1-60649-108-9
Realizing the ASEAN Economic Community: A Comprehensive Assessment, Michael G Plummer (Editor), Chia Siow Yue (Editor), Instute of South east asian studies, Singapore
REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS
(MRA 202T)
Scope
This course is designed to impart fundamental knowledge on Regulatory Requirements, Licensing and Registration, Regulation on Labelling of Biologics in India, USA and Europe
It prepares the students to learn in detail on Regulatory Requirements for
biologics, Vaccines and Blood Products
Objectives
Upon the completion of the course the student shall be able to :
Know the regulatory Requirements for Biologics and Vaccines
Understand the regulation for newly developed biologics and biosimilars
Know the pre-clinical and clinical development considerations of biologics
Understand the Regulatory Requirements of Blood and/or Its
Components Including Blood Products and label requirements
Theory 60 Hrs
1. India : Introduction, Applicable Regulations and Guidelines , Principles for Development of Similar Biologics, Data Requirements for Preclinical Studies, Data Requirements for Clinical Trial Application, Data Requirements for Market Authorization Application, Post-Market Data for Similar Biologics, Pharmacovigilance. GMP and GDP.
USA: Introduction to Biologics; biologics, biological and biosimilars, different biological products, difference between generic drug and biosimilars, laws, regulations and guidance on biologics/ biosimilars, development and approval of biologics and biosimilars (IND, PMA, BLA, NDA, 510(k), pre-clinical and clinical development considerations, advertising, labelling and packing of biologics
European Union: Introduction to Biologics; directives, scientific guidelines and guidance related to biologics in EU, comparability/ biosimilarity assessment, Plasma master file, TSE/ BSE evaluation, development and regulatory approval of biologics (Investigational medicinal products and biosimilars), pre-clinical
12
Hrs
12
Hrs
12
Hrs
and clinical development considerations; stability, safety, advertising, labelling and packing of biologics in EU
Vaccine regulations in India, US and European Union: Clinical evaluation, Marketing authorisation, Registration or licensing, Quality assessment, Pharmacovigilance, Additional requirements Blood and Blood Products Regulations in India, US and European Union: Regulatory Requirements of Blood and/or Its Components Including Blood Products, Label Requirements, ISBT (International Society of Blood Transfusion) and IHN (International Haemovigilence Network)
Herbal Products: Quality, safety and legislation for herbal products in India, USA and European Union.
12
Hrs
12
Hrs
REFERENCES
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Douglas J. Pisano , David S. Mantus ; Informa ,2008
Biological Drug Products: Development and Strategies; Wei Wang , Manmohan Singh ; wiley ,2013
Development of Vaccines: From Discovery to Clinical Testing; Manmohan Singh , Indresh K. Srivastava ;Wiley, 2011
This course is designed to impart the fundamental knowledge on the medical devices and in vitro diagnostics, basis of classification and product life cycle of medical devices, regulatory requirements for approval of medical devices in regulated countries like US, EU and Asian countries along with WHO regulations. It prepares the students to learn in detail on the harmonization initiatives, quality and ethical considerations, regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Objectives
Upon completion of the course, the student shall be able to know
basics of medical devices and IVDs, process of development, ethical and quality considerations
harmonization initiatives for approval and marketing of medical devices and IVDs
regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN
clinical evaluation and investigation of medical devices and IVDs
Theory 60 Hrs
1. Medical Devices: Introduction, Definition, Risk based classification and Essential Principles of Medical Devices and IVDs. Differentiating medical devices IVDs and Combination Products from that of pharmaceuticals, History of Medical Device Regulation, Product Lifecycle of Medical Devices and Classification of Medical Devices.
and Functions, Regulatory Guidelines, Working Groups, Summary Technical Document (STED), Global Medical Device Nomenclature (GMDN).
Ethics: Clinical Investigation of Medical Devices, Clinical Investigation Plan for Medical Devices, Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011) Quality: Quality System Regulations of Medical Devices: ISO 13485, Quality Risk Management of Medical Devices: ISO 14971, Validation and Verification of Medical device, Adverse Event Reporting of Medical device
12
Hrs
12
Hrs
USA: Introduction, Classification, Regulatory approval process for Medical Devices (510k) Premarket Notification, Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and In vitro Diagnostics, Quality System Requirements 21 CFR Part 820, Labeling requirements 21 CFR Part 801, Post marketing surveillance of MD and Unique Device Identification (UDI). Basics of In vitro diagnostics, classification and approval process.
European Union: Introduction, Classification, Regulatory approval process for Medical Devices
(Medical Device Directive, Active Implantable Medical Device Directive) and In vitro Diagnostics (In Vitro Diagnostics Directive), CE certification process.
Basics of In vitro diagnostics, classification and approval process.
ASEAN, China & Japan: Medical Devices and IVDs, Regulatory registration procedures, Quality System requirements and clinical evaluation and investigation.
IMDRF study groups and guidance documents.
12
Hrs
12
Hrs
12
Hrs
REFERENCES
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics by Douglas J. Pisano, David Mantus.
Medical Device Development: A Regulatory Overview by Jonathan S.
Kahan
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin and Gary Walsh
Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by Carmen Medina
Country Specific Guidelines from official websites.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS (MRA 204T)
Scope
This course is designed to impart the fundamental knowledge on Regulatory Requirements, Registration and Labeling Regulations of Nutraceuticals in India, USA and Europe.
It prepares the students to learn in detail on Regulatory Aspects for
nutraceuticals and food supplements.
Objectives
Upon completion of the course, the student shall be able to
Know the regulatory Requirements for nutraceuticals
Understand the regulation for registration and labeling of nutraceuticals and food supplements in India, USA and Europe.
Theory 60 Hrs
1. Nutraceuticals: Introduction, History of Food and Nutraceutical Regulations, Meaning of Nutraceuticals, Dietary Supplements, Functional Foods, Medical Foods, Scope and Opportunities in Nutraceutical Market.
Global Aspects: WHO guidelines on nutrition. NSF International: Its Role in the Dietary Supplements and Nutraceuticals Industries, NSF Certification, NSF Standards for Food And Dietary Supplements. Good Manufacturing Practices for Nutraceuticals.
India : Food Safety and Standards Act, Food Safety and Standards Authority of India: Organization and Functions, Regulations for import, manufacture and sale of nutraceutical products in India, Recommended Dietary Allowances (RDA) in India.
USA: US FDA Food Safety Modernization Act, Dietary Supplement Health and Education Act. U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements, Labelling Requirements and Label Claims for Dietary Supplements, Recommended Dietary Allowances (RDA) in the U.S
12
Hrs
12
Hrs
12
Hrs
12
Hrs
European Union: European Food Safety Authority (EFSA): Organization and Functions. EU Directives and regulations for manufacture and sale of nutraceuticals and dietary supplements. Nutrition labelling. European Regulation on Novel Foods and Novel Food Ingredients. Recommended Dietary Allowances (RDA) in Europe.
12
Hrs
REFERENCES
Regulation of Functional Foods and Nutraceuticals: A Global Perspective by Clare M. Hasler (Wiley Online Library)
Nutraceutical and Functional Food Regulations in the United States and Around the World by Debasis Bagchi (Academic Press, Elsevier)
