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  • SASPR Edu International Pvt. Ltd  (2)
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  • SASPR Edu International Pvt. Ltd  (2)
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  • 1
    Online Resource
    Online Resource
    SASPR Edu International Pvt. Ltd ; 2023
    In:  Global Academic Journal of Pharmacy and Drug Research Vol. 5, No. 03 ( 2023-06-08), p. 29-37
    In: Global Academic Journal of Pharmacy and Drug Research, SASPR Edu International Pvt. Ltd, Vol. 5, No. 03 ( 2023-06-08), p. 29-37
    Abstract: Regulatory affairs (RA) play crucial roles in the pharmaceutical industry because they are concerned with the lifecycle of healthcare products, they offer strategic, tactical, and operational direction, and they support working within the law to hasten the development and delivery of safe and effective healthcare products to people all over the world. The purpose of regulatory affairs is to create and implement a regulatory strategy to guarantee that the combined efforts of the drug development team result in a product that is acceptable to international regulators while also standing out from the competition. Microorganisms play a vital role in every field of drug such as production of antibiotics, antifungal, anticancer, vitamins, vaccines and enzymes etc. These are some examples where microbial products are widely used. In the present work we will discuss various aspects where microorganisms widely used in production of drug and their regulations in US and India.
    Type of Medium: Online Resource
    ISSN: 2706-9044 , 2707-255X
    Language: Unknown
    Publisher: SASPR Edu International Pvt. Ltd
    Publication Date: 2023
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  • 2
    In: Scholars Academic Journal of Biosciences, SASPR Edu International Pvt. Ltd, Vol. 11, No. 07 ( 2023-07-03), p. 229-233
    Abstract: This study was conducted in order to ascertain the state of affairs of the pharmacovigilance in Côte d'Ivoire, and to estimate the level of knowledge of the workers involved in the veterinary drug sector in the District of Abidjan. The methodological approach applied was first an exploratory survey on the existing regulatory texts and the activities relating to the veterinary pharmacovigilance in Côte d'Ivoire. Then, secondly, a cross-sectional descriptive survey was used to estimate the level of knowledge of the workers/actors in the sector of veterinary pharmacovigilance. The results of our investigations showed the non-existence of a veterinary pharmacovigilance system in Côte d'Ivoire because of the legal vacuum existing at the national level on this subject. This legal void is slightly addressed by a less explicit West African French speaking country organization (UEMOA) pharmaceutical regulation in terms of veterinary pharmacovigilance. The definition of veterinary pharmacovigilance and its current legal basis in Côte d’Ivoire is the Regulation No. 02/2006/CM/UEMOA, and the current law organizing the veterinary pharmacy, are unknown to the majority of the actors questioned. Almost all (97%) of the questioned actors felt the need to be informed and trained on pharmacovigilance.
    Type of Medium: Online Resource
    ISSN: 2347-9515 , 2321-6883
    Language: Unknown
    Publisher: SASPR Edu International Pvt. Ltd
    Publication Date: 2023
    Location Call Number Limitation Availability
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