July 2017

Applications are invited for suitable candidates for the position of Senior Research Fellow (SRF) to work on the following ICMR sponsored research project titled “Evaluation of Evaluation of a Multi-Marker Strategy to Prognosticate patients with Acute coronary Syndrome” under the supervision of Dr. Melvin George, Assistant Professor, Department of Clinical Pharmacology, SRM Medical College Hospital & Research Centre, Kattankulathur-603202, Kancheepuram

Post: Senior Research Fellow

Vet Mankind A div of Mankind pharma ltd

Post : Zonal manager / Area manager

Alkem Laboratories Limited, established in 1973, a Top Ten leading Indian Pharmaceutical Company with global operations, engaged in the development, manufacture and sale of pharmaceutical and neutraceutical products, which is marketed in India and 55 countries internationally, primarily in the United States. Our domestic business has grown at a CAGR of 17.6% from fiscal year 2011 to fiscal year 2015. Approved by US-FDA, MHRA and other regulatory authorities, we are looking for Energetic, Enthusiastic & Motivated personnel for our formulation unit in Daman.

Manipal, today, is a knowledge powerhouse and a brand name in higher education. Over five and half decades ago, one man, Dr Tonse Madhava Anantha Pai, had a vision which ensured that everything he did then, was consigned to posterity, making sure that generation after generation of students enjoy the fruits of his labour till eternity on this lateritic plateau. And the students will, forever, have one name on their lips, that of Manipal.

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.

Our client is a vibrant fast growing pharma co.

Post : Product Manager (Ortho/ Food Supplements)

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Post : Assoc Director, GRACS External Operations / Local Supplier

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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.