The key regulatory and compliance elements for good manufacturing practice, good laboratory practice, good automated laboratory practice and good documentation practice. Current Good Manufacturing Practice: Introduction, US Cgmp Part 210 and Part 211.EC Principles of GMP (Directive 91/356/EEC) Article 6 to Article 14 and WHO cGMP Guidelines GAMP-5; Medical Devices and IVDs Global Harmonization Task Force (GHTF) Guidance Documents. Quality management systems: Quality concept, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control.
Course Objective: Total Quality Management is a very useful chapter like – good manufacturing practice, GLP, GCP, ICH etc. Outcome: Total Quality Management helps the students to comply with the established regulatory guidelines in GMP, GCP, GLP, USFDA, WHO, ISO etc. to become a perfect budding pharmacist. Good Manufacturing Practices for Pharmaceutical Products-A Plan for Total Quality Control by Sidney H. Drugs & Pharm.
Introduction, Types of Intellectual Property Rights (Patents, Trademarks, Copyrights, Geographical Indications, Industrial Designs and Trade Secrets), Patentable Subject Matter (Novelty, Non-Applicability, Utility, Enablement and Best Mode),.
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It also aims to convey knowledge about basic concepts, assumptions, terminology and methods related to pharmacoeconomics and health-related outcomes, and when appropriate, pharmacoeconomic model should be applied to a health care regimen. Definition, scope, need, objectives and applications; Outcome measurement: Outcome measures, Drug use measures: Monetary units, Number of prescriptions, units of medicine issued, defined daily doses, prescribed daily doses, Diagnosis and Therapy surveys, Prevalence, Incidence rate, Monetary units, number of prescriptions, unit of medicine prescribed, defined daily doses and prescribed daily doses, medication adherence measurements. Qualitative models: Review of drug use; Quantitative models: case reports, case series, Cross-sectional studies, Cohort and case-control studies, Calculation of odds ratio, Meta-analysis models, Drug effect study in populations: Spontaneous reporting, Monitoring of prescription events, Post-marketing surveillance, Record linkage systems, Applications of pharmacoepidemiology.
Pharmacoeconomics Outcomes and Measurements: Types of outcomes: Clinical Outcomes, Economic Outcomes, Humanistic Outcomes; Quality-adjusted life years, Disability-adjusted life years Incremental cost-effectiveness ratio, average cost-effectiveness ratio. Definition, Steps involved, Applications, Advantages and disadvantages of the following pharmacoeconomic models: Cost Minimization Analysis (CMA), Cost Benefit Analysis (CBA), Cost.
14 Effective Analysis (CEA), Cost Utility Analysis (CUA), Cost of Illness (COI), Cost Consequences
The topics help expose students to the processes involved in the production of herbal cosmetics, including the preparation of herbal skin and hair care products and their evaluation. Course Outcome: Students will learn about the raw materials used in herbal cosmetics and will be exposed to various herbal cosmetic preparations. Skin care products: Method of preparation, pharmaceutical and pharmacological evaluation procedures for various formulations such as creams, lotions, lipsticks, face packs.
Detailed study of five formulations under each category regarding their composition and claims for various herbs used in them. Hair care products: Method of preparation, pharmaceutical and pharmacological evaluation procedures for various formulations such as hair dyes, creams, lotions, gels, oils and shampoos. A brief description of the following plants or plant extracts or plant products of cosmetic importance such as Acacia concinna pods, Aloe Vera, Almond oil, Neem, Citrus peels, Henna, Turmeric, Licorice, Olive oil, Oil of tea tree and wheat germ oil with special emphasis on their source, active principles and cosmetic properties.
UNIT - V. a) General principles of quality control and standardization of cosmetics: control of raw materials, control of packaging material, control of finished products, shelf life testing.
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Understand the regulatory requirements for blood and/or its components, including blood products and labeling requirements. Requirements for preclinical studies, data requirements for the application of clinical studies, data requirements for the application for marketing authorization, post-marketing data for similar biological medicinal products, pharmacovigilance. European Union: Introduction to Biological Medicines; guidelines, scientific guidelines and directives related to biological medicinal products in the EU, assessment of comparability/biosimilarity, plasma master file, TSE/BSE evaluation, development and regulatory approval of biological medicinal products (investigational medicinal products and biosimilars), preclinical and clinical development considerations; stability, safety, advertising, labeling and packaging of biological medicines in the EU.
Vaccine Regulations in India, USA and European Union: Clinical Evaluation, Marketing Authorization, Registration or Licensing, Quality Assessment, Pharmacovigilance, Additional Requirements Blood and Blood Products Regulations in India, USA and European Union: Regulatory Requirements for Blood and /or its components, including Blood Products, labeling requirements, ISBT (International Society for Blood Transfusion) and IHN (International Hemovigilance Network). Herbal Products: Quality, Safety and Legislation for Herbal Products in India, USA and European Union. This course is designed to impart fundamental knowledge of 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 such as USA, EU and Asian countries along with WHO regulations organizations. .
It prepares the students to learn in detail about the harmonization initiatives, quality and ethical considerations, regulatory and documentation requirements for the marketing of medical devices and IVDs in regulated countries. Medical devices: introduction, definition, risk-based classification and essential principles of medical devices and IVDs. Distinguish medical devices IVDs and combination products from those of pharmaceuticals, History of Medical Device Regulation, Product Life Cycle of Medical Devices and Classification of Medical Devices.
ISO 14971, Validation and verification of medical devices, adverse event reporting of medical devices UNIT III. United States: 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, Postmarketing surveillance of MD and Unique Device Identification (UDI). ASEAN, China and Japan: Medical devices and IVDs, regulatory registration procedures, quality system requirements and clinical evaluation and investigation.
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It prepares students to learn in detail about regulatory aspects of nutraceuticals and dietary supplements. Understand the regulation for registration and labeling of neutraceuticals and dietary supplements in India, USA and Europe. Nutraceuticals: Introduction, History of Foods and Nutraceutical Regulations, Meaning of Nutraceuticals, Dietary Supplements, Functional Foods, Medical Foods, Scope and Opportunities in the Nutraceutical Market.
NSF International: Its Role in the Dietary Supplement and Nutraceuticals Industries, NSF Certification, NSF Standards for Foods and Dietary Supplements. 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. Nutraceutical and Functional Food Regulations in the United States and Around the World by Debasis Bagchi (Academic Press, Elsevier).
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Methods of sampling and testing for various cosmetics as laid down by Bureau of Indian Standards.
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Course Objectives - To develop expertise regarding the suitability and evaluation of nanomaterials, able to apply the properties to the manufacture of nanopharmaceuticals, evaluate the intensity of dosage forms and accessibility for targeting and controlled delivery. Course outcomes – The students should be able to choose the right kind of materials, be able to develop nanoformulations with appropriate technologies, evaluate the product related test and for identified diseases.
Introduction to Nanotechnology
Synthesis of Nanomaterials
Biomedical applications of Nanotechnology a) Nanotechnology products used for in vitro diagnostics
Course Objectives: Students will be exposed to the characteristic features of various phytochemicals as neutraceuticals in various disease conditions and will also recognize the role of antioxidant in disease conditions caused by free radicals and will be exposed to the laws and regulations of different food. Course Outcome: Helps the student understand the importance of Neutraceuticals in various common problems with the concept of free radicals. Free Radicals in Diabetes Mellitus, Inflammation, Ischemic Reperfusion Injury, Cancer, Atherosclerosis, Free Radicals in Brain Metabolism and Pathology, Kidney Damage, Muscle Damage.
Regulations and Claims - Current Products: Label Claims, Nutrient Content Claims, Health Claims, Dietary Supplement Claims.
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They also know the design evaluation and application related to oral, parenteral, transdermal, implants, bioadhesives and targeted drug delivery systems. Course Outcomes: Students will know the fabrication, design, evaluation and application of the above drug delivery systems. This subject will provide an added value and current requirement for the students in Clinical Research and Pharmacovigilance.
It will teach students about the conceptualization, design, implementation, management and reporting of clinical trials. This topic also focuses on global pharmacovigilance scenarios in different methods that can be used to generate safety data. It will teach the students to develop drug safety data in preclinical, clinical phases of drug development and post-market surveillance.
Regulatory perspectives of clinical trials: origins and principles of International Conference on Harmonization - Guidelines for Good Clinical Practice (ICH-GCP) Ethics Committee: Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant Schedule Y, ICMR, Process for informed consent: Structure and content of an informed consent process Ethical principles governing informed consent process. Cohort, Case Control, Cross-sectional Clinical Trial Study Team Roles and Responsibilities of Clinical Trial Staff: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its Management. Clinical Trial Documentation: Guidelines for Document Preparation, Protocol Preparation, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT Adverse Drug Reactions: Definition and Types.
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Comparative study of registration requirements in 5 emerging markets (WHO) and development of a market approval checklist. Comparative Study of Registration Requirements in Emerging Markets (BRICS) and Preparation of Market Authorization Checklist. Comparative study of registration requirements in emerging markets (China and South Korea) and preparation of a market authorization checklist.
Comparative study of registration requirements in emerging markets (ASEAN) and preparation of a checklist for market authorization. Comparative study of registration requirements in emerging markets (GCC) and preparation of a checklist for market authorization. Preparation of the document required for the approval of herbal products with different dosage forms (3 products) according to the requirements of the regulations.
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