Latest News Approved Research Centre Recognized by ANU...

   Navigation

 

Pharma Management & Regulatory Affairs(PMRA)

  • About the Department

    The Department of Pharmaceutical Management & Regulatory Affairs was established in the year of 2010. It was started as a fifth PG course in Pharmacy at our college. This department consists of 1 Professor, 1 Assistant professor as faculty members . After successful completion of the course, till now 3 batches of students have passed out , 36 students were placed in various departments of pharmaceutical industries such as regulatory affairs, pharmacovigelance, quality assurance etc., Passed out students from the Department of Pharmaceutical Management and Regulatory Affairs (PMRA) were successful in getting the placements in various prestigious companies such as TATA consultancy services (TCS), Infosis, Mylon Labs etc.,

    About the Course & Objectives

    One of the objectives of the Regulatory Affairs course is to make available a pool of competent professionals in the area of Pharmaceutical Regulatory Affairs by providing a value based quality education, research in the areas of Pharmaceutical Regulatory Affairs. As a part of the curriculum designed by Acharya Nagarjuna University, Students of PMRA are entitled with the skills and procedures for filling of investigational new drug (IND), new drug application (NDA), abbreviated new drug application (ANDA) for approval by regulatory agencies of the country. Students are also enriched with the knowledge of filling of patent applications, layout preparations for large scale production of bulk drugs and various types of pharmaceutical dosage forms. Other subjects will also make the students to possess the knowledge related to patent search at national and international level. This course also imparts the knowledge of documentation and research writing expertise in the field of Pharmaceutical Regulatory Affairs. As a budding regulatory professionals students gain knowledge of successful drug approval processes in the international drugs market, efficient regulatory strategies to make India less dependent on foreign countries for drug requirements, giving advices to Pharmaceutical industries on regulatory aspects, dealing with the specific issues on national and international regulatory agencies, developing efficient regulatory strategies for export activities from Indian Pharmaceutical Industry.

    Seminars and Workshops Conducted:

    Academic Year Title of the Seminar 
    2014-15 Current Trends in Pharmaceutical Research
    2014-15 New Drug Approval Process in US, Europe & Other Major Countries
    2015-16 Pharmaceutical Product Development and Regulatory Requirements for U.S. market

    List of Publication from the Department

    Academic Year Name of the Faculty Journal Name & Vol. 
    2013 M V Nagabhushanam Scholars Research Library , Der Pharmacia Lettre, 2013, 5 (4):153-163. ISSN 0975-5071, USA CODEN: DPLEB4.
    2014 M V Nagabhushanam Pharmanest. Vol 5, Issue 4, July-Aug. 2014, Pages 2271-2280.
    2014 M V Nagabhushanam Pharmanest. Vol5, Issue 6, Nov.- Dec. 2014, Pages 2488-2492.
    2014 M V Nagabhushanam Pharmanest. Vol.5, Issue 6, Nov-Dece. 2014. Pages: 2464-2468.
    2014 M V Nagabhushanam Pharmanest, Vol.5, Issue 5, Sept – Oct 2014, Pages 2435-2437. eISSN 2231-0541.
    2014 M V Nagabhushanam Pharmanest, Vol.5, Issue 5, Sept – Oct 2014, Pages 2414-2416. eISSN 2231-0541.
    2014 M V Nagabhushanam World Journal of Pharmaceutical Sciences. ISSN : 2321-3310. Vol.2(12),2014.
    2014 M V Nagabhushanam Journal of Global Trends in Pharmaceutical Sciences; ISSN : 2230-7346. Vol.5(4), 2014. Page No. 2225-2232. (Universal Impact Factor 1.358).
    2014 M V Nagabhushanam Pharmanest. Vol 5, Issue 4, July-Aug. 2014, Pages 2271-2280.
    2014 M V Nagabhushanam World Journal of Pharmaceutical Sciences. ISSN : 2321-3310. Vol.2(12),2014.
    2014 M V Nagabhushanam Journal of Global Trends in Pharmaceutical Sciences; ISSN : 2230-7346. Vol.5(4), 2014. Page No. 2225-2232. (Universal Impact Factor 1.358).
    2014 M V Nagabhushanam Journal of Global Trends in Pharmaceutical Sciences. ISSN : 2230-7346.  JGTPS/5(3), 2014. Page No. 2220-2224.  (Universal Impact Factor 1.358)
    2014 M V Nagabhushanam Pharmanest, Vol.5, Issue 5, September- October 2014, Pages 2388-2390. eISSN-2231-0541
    2014 M V Nagabhushanam American Journal of Pharmacy & Health Research; ISSN:2321-3647. Vol.2, issue 11,2014. (Impact Factor 0.678)
    2014 M V Nagabhushanam American Journal of Pharmacy & Health Research ;  ISSN : 2321-3647. Vol.2, Issue 11, 2014. (Impact Factor 0.678)
    2014 M V Nagabhushanam American Journal of Pharmatech Research, 2014 ; 4(6); ISSN:2449-3387.(Impact Factor 0.983, Imapct C Value 6.8)

    Details of Grants Received

    Academic Year Statutory Body Amount Received
         

    List of ongoing Research Projects

    Comparative study of GMPs for US FDA, EMA and CDSCO.
    Generic drug filing requirements for ROW countries.
    Current International Regulations for Natural systems of Medicine.
    New Drug approval Process in Singapore and Registration of Multi source drug products.
    Overview of dossier comparison of major regulatory bodies and eCTD modules.

    Equipment Available in the Department

    S.No NAME OF THE EQUIPMENT Qty
    1 Computers 10
    2 fixed DLP & Wall Screen for Projection 1
    3 SAMSUNG printer cum scanner 1

    Students Details

    Academic Year No. of Sanctioned Seats No. of Students Admitted No. of Students Passed
    2010-11 18 18 18
    2011-12 18 16 16
    2012-13 18 02 02
    2013-14 18 05 05
    2014-15 18 14 Presently in First year
  • Dr. M.V.Nagabhushanam
    M.Pharm., Ph.D
    Professor & HOD
    Mr.D.Nagarjuna Redy
    M.Pharm
    Asst. Professor
     
    Mr.B.Brahmaiah
    M.Pharm,(Ph.D)
    Asst. Professor
     
 
 
COLLEGE CODES SOCIAL MEDIA COMMUNICATION

EAMCET Code for B.Pharm, Pharma D : HICP

GPAT/PGECET Code for  M.Pharm & Pharm.D (PB) : HICP1
                                                                    

Follow us by clicking the icon below.

     
Hindu College Of Pharmacy
Phone: 0863 – 2221935, 2217783,
E – mail : hinducollegeofpharmacy@yahoo.com
 
         All Rights @ Reserved to HCOPGNT