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ABOUT AUTHORS
MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

ABOUT INSTITUTE
ADINA Institute of Pharmaceutical Sciences was established in 2005 under aegis of Shri. Prem Chand Jain Memorial Society For Education. We are providing research oriented education in its fully wi-fi campus, experienced faculty members as per the norms and standards of AICTE, PCI and RGPV. AIPS has mordem lecture halls, well equipped laboratories, e-library, computer labs with internet facility. It is an ISO 9001 : 2000 certified institute, it is offering B. Pharm & M. Pharm in three disclipine : Pharmaceutics, Pharmaceutical chemistry and Pharmacology.

Applications are invited from the qualified and eligible candidates for filling up of the following vacancies on Contract basis, initially for a period of six months to discharge their duties in I.T.D.A., Parvathipuram Area and roster points in Health Medical & Family Welfare Department, Government of Andhra Pradesh. Applications may be sent to the DM&HO., Vizianagaram for which application is made.

Post : Pharmacist Gr.II

Dr Ram Manohar Lohia Institute of Medical Sciences is centrally located in Vibhuti Khand, Gomti Nagar, Lucknow. The hospital affiliated to the institute offers high end services and treatment in various superspeciality medical disciplines and also offers teaching facilities imparting degrees of D.M., M.Ch., M.D., M.S., Ph.D. as well as paramedical diploma programs.

Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, an autonomous Institute of U.P. Govt. invites Online applications on prescribed format for the posts mentioned as below.

Post : Pharmacist (GEN 01 post)

Indegene is a recognized global leader in providing noticeable healthcare solutions and services and partner to some of the largest and most respected healthcare organizations. Being associated with Indegene, an equal opportunity employer, is about making tangible contributions with a focus to deliver outcomes that are measurable, impactful, and sustainable. We are a team of more than 1,200 employees across 14 global locations.

Post : Clinical Data Manager

Eisai Inc. is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $3.9 billion in fiscal year 2009 (year ending March 31, 2010).

Post : Health Care Executive

CACTUS is a pioneering global scientific communications company. In everything we do, we want to accelerate the development of global scientific research, by helping science break through the confines of geography and language. To this end, we partner with academic and pharmaceutical communities worldwide and leverage the expertise of 1400+ professionals to create compelling, high-quality scientific communications. Browse through the tabs below for a closer look at CACTUS.

Post: Associate, Project Management

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Regulatory Coordinator

Working at Cargill is an opportunity to thrive—a place to develop your career to the fullest while engaging in meaningful work that makes a positive impact around the globe. You will be proud to work for a company with a strong history of ethics and a purpose of nourishing people. We offer a diverse, supportive environment where you will grow personally and professionally as you learn from some of the most talented people in your field. With 150 years of experience Cargill provides food, agriculture, financial and industrial products and services to the world. We have 150,000 employees in 70 countries who are committed to feeding the world in a responsible way, reducing environmental impact and improving the communities where we live and work.

Post : QC-OFFICER-BAN01994

Today’s Bhagat Phool Singh Mahila Vishwavidyalaya is the ‘dream come true’ of Bhagat Phool Singh Ji, who established a Gurukul for girls at Khanpur Kalan in 1936. Even after the demise of Bhagat Phool Singh, his equally dynamic daughter Subhashini Ji not only took control of Gurukul but worked vigorously in expanding the Gurukul in terms of its various constituent institutions like BPS Memorial Girls’ College (1967), BPS College of Education (1968), MSM Ayurvedic College (1973), BPS Mahila Polytechnic (1984), TIG Bhainswal Kalan(1999) and PSD Girls’ Law College (2003).

Post : Professor - Pharmacy

Applications are invited online only from qualified candidates belonging to the following reservation group of community of Kerala State for appointment in the under mentioned post. Application must be submitted online through the Official website of the Commission after One Time Registration. Candidates who have already registered can apply through the profile.

Post : Pharmacist Gr-II (Ayurveda)

Indian Institute of Technology - Roorkee is among the foremost of institutes of national importance in higher technological education and in engineering, basic and applied research. Since its establishment, the Institute has played a vital role in providing the technical manpower and know-how to the country and in pursuit of research. The Institute ranks amongst the best technological institutions in the world and has contributed to all sectors of technological development. It has also been considered a trend-setter in the area of education and research in the field of science, technology, and engineering.

Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds.  Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.

Post : Executive R&D

Regional Centre for Biotechnology (RCB) is an autonomous academic institution established by the Department of Biotechnology, Govt. of India with regional and global partnerships synergizing with the programmes of UNESCO as a Category II Centre. The primary focus of RCB is to provide world class education, training and conduct innovative research at the interface of multiple disciplines to create high quality human resource in disciplinary and interdisciplinary areas of biotechnology in a globally competitive research milieu. RCB provides a platform for interdisciplinary research & education at the biotech interface of engineering & medicine, chemistry & physics, agriculture & climate science to empower human resources to drive biotech science and provide a common platform for innovation, enterprise, and industrial development to germinate. The Centre would be beneficial to India as well as other Member States of UNESCO in this region towards developing knowledge-rich, highly skilled human resource, harmonizing policies & procedures in biotechnology and indirectly promoting trade.

Post: JRF

SHRI VISHNU COLLEGE OF PHARMACY: was established in the year 1997 by the well known Philanthropist and Industrialist, Late Padmabhushan Dr. B. V. Raju under Dr. B. V. Raju Foundation and Shri Vishnu Educational Society. With the Demise of the founder Chairman in June, 2002, Sri K. V. Vishnu Raju, his grandson succeeded as Chairman and is making all efforts to impart the Quality Education.

Assam University came into existence through Assam (Central) University Act, 1989 (Act. No. XIII). It was  established in 1994, since then the University is steadily becoming an excellent centre of learning. The campus, situated in Dargakona, about 20 kms from  Silchar, is set amid sprawling hillocks, a typical landscape in the  North East. The campus  in an area of  600 acres surrounded by lakes and mountains provides  an ideal environment for academic pursuit.

Applicants are invited to appear in a walk-in-interview for 1 (one) post of Junior Research Fellow in the DBT (GOI) funded project entitled “Investigating the molecular basis of the anti-parkinsonian effects of Garcinol-a phytoconstituent of Garcinia sp. in animal model of Parkinson’s disease” for a period of two (02) years (may be extended by 1 year).

Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits...

Post : Executive Quality Control

Our goal is to provide the world's 7 billion people with access to high quality medicine. What is yours? Mylan is one of the world's leading generic pharmaceutical company, providing products in around 165 countries, though our global workforce of more than 35,000 passionate leaders. If you resonate with our audacious ambition to provide the world's 7 billion population with access to high quality medicine, with state-of-the-art. Finished Dosage Forms (FDF) manufacturing facilities at Indore. This facility is compliant of USFDA, WHO, MHRA, MCC, and ANVISA.

Post : Sr. Chemist/Officer/Executive/Assistant Manager

Boehringer Ingelheim is an equal opportunity employer who takes pride in maintaining a diverse and inclusive culture. We embrace all aspects of diversity and inclusion which benefit our employees, patients and communities. Minority/Female/Protected Veteran/Person with a Disability (Applicable in United States of America).

Post : Medical Advisor, Mumbai-177134