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  • Deshpande, Shrikalp  (5)
  • 1
    Online Resource
    Online Resource
    Good e-Governance: Xtended Licensing, Laboratory & Legal Node (XLN) - An effective tool for Good Regulatory Practice in field of Drugs and Cosmetics Regulation
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 1 ( 2023-03-17), p. 43-46
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 1 ( 2023-03-17), p. 43-46
    Abstract: Food & Drug Control Administration (FDCA), can be credited with an iron hand and will of the regulator combined with the strict vigil and a friendly hand holding for all of its stake holders i.e., manufacturers of drugs, wholesalers, retailers, stockiest, C & F agents etc. The enforcement mission targets to fulfill the objective of making available the safe and effective medicines by ensuring that the menace of manufacture of spurious /substandard drugs is eradicated. For the enforcement activities it is vital to have immediate and accurate access to information as well as there is a need to communicate effectively and quickly with the stake holders. Prior to the initiative of implementation of software, SMS alerts etc. the enforcement task was dependent on manual means of actions and communications. Gujarat FDCA implemented web-based software - Xtended Licensing & Laboratory Node (XLN), http://xlnfda.guj.nic.in/login.aspx, with data stored in the central server. The aim behind e-governance was to create a system to bring about transparency, traceability, simplicity, effectiveness, harmonization, speed, accuracy and accountability in various G2G, G2C and G2B functions of the department and to attain & maintain FDCA’s leadership in drug regulations in India.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i1.579
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Abstract: Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.616
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Regulatory Prospective on Software as a Medical Device
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 13-17
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 13-17
    Abstract: Software is becoming increasingly important in medical devices and digital adoption more broadly. It is becoming more important as a medical device in its own right. (1) Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control and clinical evaluation for SaMD. Millions of users use AI based medical device for the diagnosis & Management of diseases. Regulation for the SaMD, IMDRF published guidance document in 2013, in EU they are regulated by EMA, in Australia they are regulated by TGA and in Canada they are regulated by Health Canada. Regulations of these countries and IMDRF were reviewed and articles of challenges in artificial intelligence based medical devices reviewed. There are also many challenges like cybersecurity, safety, and decommissioning, high cost of device and also the design and development process. The objective is to focus on SaMD’s regulations and Challenges.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.545
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Similarities and differences in filing for Drug Master File in US, Canada and Europe
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-19), p. 33-38
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 33-38
    Abstract: Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisory demand to file a DMF. Drug Master Files (DMF) is a document containing complete information on an Active Pharmaceutical element (API) or finished drug capsule form. Though there are no non-supervisory conditions to file a DMF, the benefit of its use is inviting. A drug Master Files (DMF) is an voluntary non-supervisory submission and is submitted at the discretion of the DMF holder to help their guests. A DMF is NOT a cover for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. An Active Substance Master File (ASMF) is the presently honored term in Europe, formerly known as European drug Master file (eDMF) or a US- Drug Master File( US- DMF) in the United States.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.613
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 1-7
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 1-7
    Abstract: This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.523
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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