Pharmapedia

ABOUT AUTHOR
Rajesh Vagh
PharmaTutor Edu Labs
Surat, Gujarat, India

So far, medical representatives are assets for pharma sales but need of time and competitions are asking for variant ways to promote their products. Patient portals, apps and online communities should be developed with more intensity and utilize technologies to improve customer experience.

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ABOUT AUTHOR
Dr. Vishwas B. Chavan
Aditya Jyot Hospital & Foundation
vishwaschavan2003@yahoo.co.in

Cancer is a leading cause of morbidity and mortality in the world today. According to one study, there were 14.1 million new cases of cancer and 8.2 million cancer-related deaths worldwide in 2012. The most commonly diagnosed cancers were lung (1.82 million), breast (1.67 million), and colorectal (1.36 million). The most common cancer deaths are due to lung cancer (1.6 million deaths), liver cancer (745,000 deaths), and stomach cancer (723,000 deaths) (Ferlay, J. et al, 2015).

ABOUT AUTHORS
Piyush Tripathi*,  Abhishek Arora
GMSCL,
GUJARAT(INDIA)
^*piyushtripathi1992@rediffmail.com

Drug addiction is a serious problem in one country that is known for its culture, traditions & social values all over the world. The country where people commit suicide either because of love affairs or due to drug addiction related issues. Undoubtedly, this writing is talking about India.

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ABOUT AUTHORS
BALVINDER SINGH¹*, PAWAN JALWAL ¹, VIKASH KUMAR RUHIL ², NEHA MINOCHA¹
1.Department of Pharmaceutical Sciences & Research, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, India
2. P.D.M. College of Pharmacy, Bahadurgarh, Haryana, India
balvindersinghpharmaco@gmail.com

ABSTRACT
B.Pharmacy course is one of the leading professional courses in India. Two types of examinations are prevalent in B.Pharmacy course. One is the sessional examinations for internal evaluation. Second is the semester end/year end examination. Each examination has its own importance. The student should be well prepared for appearing in the examination. Appearing in the B.Pharm. Examination is not only merely science but it requires amalgamation of science and art.

ABOUT AUTHOR
Purva Gupta.
IIHMR, New Delhi.
purvagupta456@gmail.com

New Domain: This problem arises when organisation has not handled similar project earlier and stake holders have no prior experience on the project.

New Technology / Challenging Technology: Selected Project involves use of new technology or new equipment or specially trained staff may pose delay in completion of task, thereby project.

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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.