Pharmaceutical Market and Regulatory Issues for Export of Pharmaceutical Products to Latin American Countries
Indian Pharmaceutical industry is one of the world’s largest and most developed, ranking fourth in terms of volume and thirteenth in terms of value. The country accounts for an estimated 10% of global production and 2% of world markets in pharmaceuticals. The regulatory process to obtain marketing authorizations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to pharmaceutical products import from India. The comforts and confronts faced by pharma companies in India. It is of case study approach and presented the Indian pharma export advantages, the Government initiatives toward the export market, problems, the recent US trademark legislation issues, and the opportunities in a nutshell. Indian companies have focused on export prospects in both formal and informal markets globally. Keeping the high credibility of serving quality products in the complex market, India has gained a strong reputation among the global place.
Published by: Gopala Krishna Mukkamala, Sabareesh .M, Alagusundaram .M, Jayachandra Reddy .P
Author: Gopala Krishna Mukkamala
Paper ID: V3I4-1244
Paper Status: published
Published: July 29, 2017
Overview of Regulatory Guidelines for Medical Devices
Medical devices are becoming more important in the health care unit. Diversity and intricacy of medical devices in last two decades. Regulation of these devices has also advanced due to the requirement for a steady regulatory perspective. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Australia, Brazil, India, Japan, Russia, MENA countries and compares them with the requirements in the European Union. The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. Now with the availability of different regulations of the countries or region on medical devices, there is a need to harmonize regulations in order to curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. Most countries are trying to harmonize the regulatory guidelines for medical devices through their participation in Global Harmonization Task Force (GHTF). Harmonized regulation of medical device will lead to the availability of quality product.
Published by: Pakala Jayasree, Jyothshna Devi .K, Alagusundaram. M, Jayachandra Reddy .P
Author: Pakala Jayasree
Paper ID: V3I4-1251
Paper Status: published
Published: July 28, 2017
Project Planning and Delay Analysis For 2×300 MW EMCO Thermal Power Plant
Proper planning and scheduling is very important in construction projects for reducing and controlling delays in the project. Substantial amounts of time, money, resources are wasted each year in the construction industry due to improper planning and scheduling. With globalization, the construction projects have become big. Planning of such projects require huge amount of paperwork, which can be reduced with the help of project planning software. The main objectives of this study is to plan, schedule, and track with help of primavera, and study the results generated. Also, to recommend measures to the organization for enhancing the project planning skills for similar projects in future. The construction delay is a main problem in large construction industry of India. Large construction industry is very important for the development, economy and progress of India. Delay to projects is one of the foremost concerns of the construction industry in India. The delays to the projects are affecting the economies throughout the world. Delay to projects mean the slowdown of development in all other related fields. Construction project management is vital for accomplishing pre-determined objectives. Despite using construction management, most of the projects do not meet original time schedule or has been delayed. Delay is one of the biggest problems faced by construction industry. This project is a study or research to approach and analysis to avoid and control the time delay in construction in India. This research will review delay factors through literature review and scheduling through primavera. To carry out this research, comprehensive literature review is done to provide the background, history and delay factors of project management in construction. The information of literature review will be used for planning and scheduling and will be a great support to planning department to control the delay in constructions.
Published by: Mohammad Zeyauddin, Masoom Reza, Shahzeb Md. Danish
Author: Mohammad Zeyauddin
Paper ID: V3I4-1229
Paper Status: published
Published: July 28, 2017
Novel Approach For Spectrum Sensing of Primary use by Hybrid Swarm Intelligence in Cognitive Radios
In cognitive radio spectrum sensing is important challenge for secondary user but not challenge for primary user because primary give bandwidth and secondary user acquired bandwidth, when two or more user acquired same bandwidth which increase the error.so reduce the false detection and increase band width is main objective of this paper. In this paper comparison with Particle swarm optimization and hybrid swarm and ANT colony method, In our experiment show the PSO with Ant colony optimisation better throughput and true detection rate.
Published by: Manpreet Kaur, Mayank Joshi
Author: Manpreet Kaur
Paper ID: V3I4-1226
Paper Status: published
Published: July 28, 2017
Comparison and Analysis of Multistoried R.C.C Building in Different Seismic Zones
The principle objective of this project is to analyses and design a multistoried building [G + 21 (3 dimensional frame)] using STAAD Pro. And comparing the results on basis of 1. Economic 2. Difference in material requirement 3. Degree of stability under different seismic zones 4. Level of supervision of construction 5. Requirement of special tool and equipment Therefore the four requirements named as 1. Utility 2. Safety 3. economical 4. elegance Must be fulfilled for a structural design to be satisfactory. This project presents a comparative study on design a multistoried RCC building in different seismic zones in India by limit state method. The design involves load calculations manually and analysing the whole structure by STAAD Pro.Based on Limit State Design conforming to Indian Standard Code of Practice IS: 456, IS: 1893, IS: 13920, IS: 875.The structure was subjected to self-weight, dead load, live load, wind load and seismic loads. Under the load case details of STAAD.Pro. The wind load values were generated by software considering the given wind intensities at different heights and strictly abiding by the specifications of IS 875. Seismic load calculations were done following IS 1893-2005. The materials were specified and cross-sections of the beam and column members were assigned. The supports at the base of the structure were also specified as fixed. The codes of practice to be followed were also specified for design purpose with other important details. After completion of the design, we can work on the structure and study the bending moment and shear force values with the generated diagrams. We may also check the deflection of various members under the given loading combinations. The design of the building is dependent upon the minimum requirements as prescribed in the Indian Standard Codes. The minimum requirements pertaining to the structural safety of buildings are being covered by way of laying down minimum design loads which have to be assumed for dead loads, imposed loads, and other external loads, the structure would be required to bear. Strict conformity to loading standards recommended in this code, it is hoped, will ensure the structural safety of the buildings which are being designed. Structure and structural elements were normally designed by Limit State Method.
Published by: Arvind Kumar Gupta, Mirza Aamir Baig
Author: Arvind Kumar Gupta
Paper ID: V3I4-1233
Paper Status: published
Published: July 28, 2017
Design & Analysis of Polyethylene Terephthalate Based Sandwich Beam with Ansys
The present work aims to study the design and analysis of functionally graded layered sandwich beam with viscoelastic core (Polyethylene terephthalate) in high thermal environment. The top layer is functionally graded material (Ceramic S3N4) and stainless steel on the bottom. The report is divided into five chapters. First two chapters give Introduction and Literature survey of various viscoelastic core with Functionally graded material (FGM) that have unique and different properties from any other material. Materials and Methods used are given in chapter three. Chapter four provides details of ANSYS Software where the sandwich beam is subjected to axial dynamic loaded conditions. The viscoelastic core (Polyethylene terephthalate) layers is observed to be at high temperature but other layer of the beam are at normal conditions. The temperature variation is non-linear in viscoelastic core (Polyethylene terephthalate). The effect of various system parameters such as core thickness ratio, compression, expansion, modal structure test, thermal test are analyzed using ANSYS software. The thickness of beam is responsible for their displacement and boundaries for stable and unstable region are considered in this work. It is found that the buckling load of the beam decreases with increase in core thickness parameter, and temperature of top face of functionally graded material. Temperature variation along thickness has negligible effect on buckling load as well as on natural frequency. In this study as frequency of the beam increases deformation starts first in Polyethylene terephthalate layer of the beam. The instability of the beam increases with increase in core thickness parameter and temperature of the top layer.
Published by: Rohit Kumar Singh, Nidhi Sindhu, Sushil Kumar Singh
Author: Rohit Kumar Singh
Paper ID: V3I4-1245
Paper Status: published
Published: July 28, 2017
