Nutraceuticals, Medical devices, In-vitro Diagnostic Medical Devices (IVDs) and biological products and understand the rationale behind these requirements and will suggest ways and means to meet them. Introduction, Types of Intellectual Property Rights (Patents, Trademarks, Copyright, Geographical Indications Industrial Designs and Trade Secrets), Patentable Subject Matter (Novelty, Non-obviousness, Utility, Empowerment and Best Mode). Course Objective: This course is designed to impart the fundamental knowledge about 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 USA, EU and Asian countries along with WHO regulations.
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. Regulatory approval process for medical devices and IVDs in India, USA, Canada, EU, Japan and ASEAN. 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, Medical device validation and verification, Medical device adverse event reporting UNIT - III. USA: Introduction, Classification, Regulatory Approval Process for Medical Devices (510k) Premarket Notification, Premarket Approval (PMA), Investigational Device Exemption (IDE) and In Vitro Diagnostics, Quality System Requirements 21 CFR Part 820, Labeling Requirements 21 CFR Part 801, MD Postmarketing Surveillance and Unique Device Identification (UDI).
European Union: Introduction, Classification, Regulatory Approval Process for Medical Devices (Medical Device Directive, Active Implantable Medical Device Directive) and In Vitro Diagnostics (In Vitro Diagnostic Directive), CE Certification Process. ASEAN, China and Japan: Medical Devices and IVDs, Regulatory Registration Procedures, Quality System Requirements and Clinical Evaluation and Investigation. Course objective: The student must know the introduction, scope of biostatistics and research work, calculation and presentation of the data.
Pharm I Year II Sem (Pharmaceutical Regulatory Affairs)
Textbook of Clinical Trials, edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons. Course Outcomes: Helps the student understand the importance of nutraceuticals in various common problems with the concept of free radicals. Introduction to free radicals: free radicals, reactive oxygen species, formation of free radicals in cells, harmful reactions of free radicals on lipids, proteins, carbohydrates, nucleic acids.
2000 Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs), and Shelf Life Testing in Essentials of Functional Foods M. They also apply design, evaluation, and applications related to oral, parenteral, transdermal, implant, bioadhesive, and targeted drug delivery systems. Course Outcomes: Students will select drugs for CDDS design of formulation manufacturing systems of the above drug delivery systems with relevant applications.
Vaccine Delivery: Delivery systems used to promote uptake, absorption enhancers, oral immunization, controlled release microparticles shape vaccine development.
Pharm II Year I Sem (Pharmaceutical Regulatory Affairs)
Course Objectives: This particular study of the course aims to achieve, to enable the student to effectively manage a given organization in planning, hiring, staffing, selection training and other maintenance of infrastructure apart from design, layout and handling of the equipment. Course Outcome: This subject aims at validating various processes, equipment methods and efficient handling of waste materials. Human Resource Management: Personnel planning, job analysis and design, recruitment, Personnel selection, orientation and placement, training and development, supervision, performance appraisal key result area and key performance area remuneration and salaries, Compensation and incentives, industrial relations, motivation.
Production organization, good manufacturing practice objectives and policies, building, services, equipment and their maintenance, materials management, handling and transportation, inventory management and control, production planning and control, vendor selection, purchasing cycle, sales forecasting, budgeting and control costs. Validation of processes: General principles of validation, Regulatory bases, validation of pharmaceutical equipment and processes, validation of analytical methods. Solid waste, solid waste management, noise pollution, noise abatement, analysis and methods of wastewater treatment, wastewater treatment in formulation plants, wastewater treatment in the synthetic drug industry, wastewater treatment in the fermentation industry, introduction of Echo pharmacovigilance.
Course Objective: Students to know about pilot plant scale-up techniques for the production of capsules, suspensions, emulsions and semi-solid tablets. Students also know about capsule filling, compression machines, sterilizers for parenteral formulation and also know about propellants, DPI, MDI and their quality control. Course Outcomes: Students will know about plant growth and piloting techniques used for all pharmaceutical dosage forms such as tablets, capsules, parenterals, aerosols, cosmetics and nutraceuticals.
Pilot plant: Technology transfer from R&D to pilot plant to pilot scale considerations of steps involved in manufacturing, layout design, facility, equipment selection of tablets, capsules, suspensions, emulsions and semi-solids. Scale-up: Meaning, Scale-up of process size reduction, blending, mixing, granulation, compression, coating involved in tablets, capsules and liquid-liquid mixing. Formulation Development of Parenteral Dosage Forms: Advances in Materials and Manufacturing Techniques, Filling Machines, Sterilizers, Product Layout.
Pharmaceutical aerosols: Advances in propellants, metered dose inhaler designs, dry powder inhalers, container selection and formulation aspects in aerosol formulation, manufacture and quality control. Understand the skills needed when writing a headline. Make sure the paper is of good quality from the first delivery. Planning and preparation, Ordering words, Breaking up long sentences, Structuring paragraphs and sentences, being concise and removing redundancy, avoiding vagueness and ambiguity.
Pharm (Pharmaceutical Regulatory Affairs)
46 JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD. Eds.),” Experiences and Reflections in Disaster Management,” Prentice Hall of India, New Delhi. The technical scholars equipped with Sanskrit will be able to explore the vast knowledge of ancient literature. Addressing the growth of Indian opinion on the constitutional role of modern Indian intellectuals and the right to civil and economic rights, as well as the rise of a nation in the early years of Indian nationalism.
To discuss the role of socialism in India after the onset of the Bolshevik Revolution in 1917 and its influence on the initial drafting of the Indian Constitution. Discuss the growth of the demand for civil rights in India for the majority of Indians before Gandhi's arrival in Indian politics. Discuss the intellectual origins of the argumentative framework that underpinned the conceptualization of the social reforms that led to the revolution in India.
History of the Making of the Indian Constitution: History Drafting Committee, (Composition and Working), Philosophy of the Indian Constitution: Preamble, Salient Features. Block level: organizational hierarchy (different departments), village level: role of elected and appointed officials, importance of grassroots democracy. Review the existing evidence on the assessment topic to inform program design and policy making by DfID, other agencies and researchers.
What is the evidence about the effectiveness of these pedagogical practices, in which conditions and with which population of learners. How can teacher training (curriculum and practicum) and the school curriculum and guidance materials best support effective pedagogy. Evidence on the effectiveness of pedagogical practices, Methodology for the depth stage: quality assessment of included studies.
How can teacher training (curriculum and practicum) and the school curriculum and guidance materials best support effective pedagogy? Professional development: alignment with classroom practice and follow-up support, peer support, principal and community support. Research Gaps and Future Directions: Research Design, Contexts, Pedagogy, Teacher Education, Curriculum and Assessment, Dissemination and Research Impact.
