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June 2017

 

 

academics

 

Clinical research courses

Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda® (mesalamine).

AstraZeneca and its global biologics research and development arm, MedImmune, will present the latest research from the Company’s Cardiovascular and Metabolic Diseases (CVMD) therapy area, including for Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) for injectable suspension, with more than 50 abstracts at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, USA 9-13 June 2017.

Recruitment for M.Pharm, B.Pharm in Drug Cell as Consultant under NHM | Emoluments upto Rs 45000 pm

The Union Cabinet vide its decision dated 1st May 2013 has approved the launch of National Urban Health Mission (NUHM) as a Sub-mission of an over-arching National Health Mission (NHM), with National Rural Health Mission (NRHM) being the other Sub-mission of National Health Mission. Within the broad national parameters and priorities, states would have the flexibility to plan and implement state specific action plans.

Job for M.Pharm, M.S Pharm as Junior Research Fellow at Birla Institute of Technology & Science

The Birla Institute of Technology & Science (BITS), Pilani is an all-India Institute for higher education. The primary motive of BITS is to “train young men and women able and eager to create and put into action such ideas, methods, techniques and information”. The Institute is a dream come true of its founder late Mr G.D.Birla – an eminent industrialist, a participant in Indian freedom struggle and a close associate of the Father of Indian Nation late Mr. Mohandas Karamchand Gandhi (Mahatma Gandhi).

Applications are invited from the eligible candidates to work as Junior Research Fellow (JRF) in Science and Engineering Research Board (SERB), DST, Govt of India sponsored projects at Department of Pharmacy, BITS Pilani, Pilani Campus.

Post : JRF

Walk in interview for Fresher M.Pharm in Formulation & Analytical development at Sanofi-Synthelabo | 20 posts

Sanofi-Synthelabo (India) Private Limited was incorporated in June 1996 under the name Sanofi Torrent (India) Private Limited. Its name was changed to Sanofi-Synthelabo (India) Limited in May 2002. Sanofi-Synthelabo (India) Limited has around 70 employees.  Sanofi-Synthelabo (India) Limited operates as a pharmaceutical company in India. It specializes in various therapeutic groups, such as thrombosis, cardiovascular, and neurology.

Post : Formulation & Analytical development

Applications are invited Senior Research Fellowship at IITK

The history of the IIT system dates back to 1946 when a committee was set up by Hon'ble Sir Jogendra Singh, Member of the Viceroy's Executive Council, Department of Education, Health and Agriculture to consider the setting up of Higher Technical Institutions for post war industrial development in India. The 22 member committee headed by Sri N.R.Sarkar, in its report, recommended the establishment of four Higher Technical Institutions in the Eastern, Western, Northern and Southern regions, possibly on the lines of the Massachusetts Institute of Technology, USA, with a number of secondary institutions affiliated to it. The report also urged the speedy establishment of all the four institutions with the ones in the East and the West to be started immediately.

Post : Senior Research Fellowship

A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
1Veerendra Kr. Gautam*, 2Mohamad. Irfan
1Executive in Drug Regulatory Affairs Department; East African (India) Overseas
1 120 Suncity Business Tower,Sector-54, Gurgaon-122002 (Haryana).
2Research Associate; Jubilant Chemsys Ltd.
2D-12, Sector 59, Noida , Uttar Pradesh, India
1dra.veerendra.gautam@gmail.com;
1viren.gautam.dra@gmail.com 2mohd.irfan.ivar@gmail.com

Abstract : Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries. ACTD act as bridge between regulatory requirements of developed and developing countries. Also if both guidelines of CTD and ACTD can be harmonized then differences and variation between both guidelines can be minimized.

Job for Associate/ Senior Associate at Zoetis

The incumbent will be responsible to support analytical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, formulation, API scale up etc) to best support product and process development in line with project plan. Candidate will be responsible for supporting multiple projects and the interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the analytical activities outsourced to vendors. The candidate will be responsible for authoring various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.

Post : Associate/ Senior Associate

Bioclinica looking for Drug Safety, Pharmacovigilance | walk in

Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.

Post : Pharmacy, Dental & Nursing Freshers - Drug Safety / Pharmacovigilance