SUSAR Reporting to National Competent Authority Indicator

Indonesia as a mega biodiversity country is very attractive for bioprospectors. The complementarity between SDG and PT-SDG in the SDG preservation considered those must be managed by the same institutions that their function as development resource could be fullest utilized. And look at the complexity of managing the SDG and PT-SDG it is recommended that National Competent Authority agencies is to be set up under the president or vice president responsibilityIndonesia adalah mega biodiversity country yang sangat menarik bagi para bioprospektor. Saling kelindan SDG dan PT-SDG dalam pelestarian SDG menyebabkan SDG dan PT-SDG harus dikelola oleh lembaga yang sama agar fungsinya sebagai sumber daya pembangunan dapat didayagunakan secara maksimal. Dan melihat pada kompleksitas pengelolaan SDG dan PT-SDG maka disarankan agar lembaga National Competent Authority yang akan dibentuk itu berada dalam tanggungjawab presiden/wakil presiden

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Informes periódicos de seguridad en farmacovigilancia veterinaria

Revista Científica y Tecnológica UPSE ◽

10.26423/rctu.v3i2.161 ◽

2016 ◽

Vol 3 (2) ◽

pp. 105-109

Author(s):

Francisco Jaramillo

Keyword(s):

Marketing Authorisation ◽

Adverse Reactions ◽

Competent Authority ◽

Target Species ◽

National Competent Authority ◽

Periodic Safety ◽

Marketing Authorisation Holder ◽

Authorisation Holder

Los Informes Periódicos de Seguridad son documentos de seguimiento post autorización que deben ser remitidos por parte del Titular de un producto farmacéutico veterinario a la Autoridad Nacional Competente, en una temporalidad determinada, para informar reacciones adversas. Para su elaboración se debe disponer de la información respecto a cantidad de producto vendido y especies de destino.AbstractThe Periodic Safety Update Reports are documents of post authorization monitoring that must be submitted by the Marketing Authorisation Holder to the National Competent Authority, in a specific temporality, to report adverse reactions. Its preparation must have the information regarding amount of selling product and target species.

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Green Management: A study of best green practices in Haryana Private Universities

Think India ◽

10.26643/think-india.v22i1.8364 ◽

2019 ◽

Vol 22 (1) ◽

pp. 51-59

Author(s):

Priyanka ◽

Ipshita Bansal

Keyword(s):

Best Practices ◽

Private Universities ◽

Competent Authority ◽

Green Management ◽

Carbon Footprints ◽

Staff Members ◽

Research Concept ◽

Green Campus ◽

The Relationship ◽

Operational Aspect

As per the current condition of environment degradation, most of the higher education institutions are working on making the campus green and implementing sustainability in curriculum as well as working of institution. The current study focuses on green management of campuses of private universities of Haryana on operational aspect of institution and determine the best practices that were adopted and should be adopted in order to implement sustainability processes. Green management means the integration of principle of Management and environment management that form the relationship between environment and management. The data is collected from, private universities of Haryana through studying the documents, website and interview of competent authority of universities. Based on the research, concept of green campus has been purposed which involve the smart sharing of resources, development of green buildings and reducing the use of transportation and carbon footprints. In addition, the study also conclude that sustainability and green management should be made the integral part of the attitude of students, scholars and staff members for making the campus green. So, the best practices should be adopted across various area of institution for making the environment sustainable green campus and forming the positive attitude of students and staff members towards sustainability.

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[18F]F-PSMA-1007 Radiolabelling without an On-Site Cyclotron: A Quality Issue

Pharmaceuticals ◽

10.3390/ph14070599 ◽

2021 ◽

Vol 14 (7) ◽

pp. 599

Author(s):

Valentina Di Iorio ◽

Stefano Boschi ◽

Anna Sarnelli ◽

Cristina Cuni ◽

David Bianchini ◽

...

Keyword(s):

Quality Assurance ◽

Radiochemical Purity ◽

Competent Authority ◽

Radiochemical Yield ◽

Synthesis Process ◽

Control Parameters ◽

Quality Issue ◽

Assurance System ◽

Quality Control Parameters ◽

Specific Membrane

Radiopharmaceuticals targeting the prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer. [68Ga]Ga-PSMA-11 has been the forerunner but a [18F]F-PSMA ligand has been developed because of the intrinsic advantages of Fluorine-18. Fluorine-18 labelled compounds are usually prepared in centers with an on-site cyclotron. Since our center has not an on-site cyclotron, we decided to verify the feasibility of producing the experimental 18F-labelled radiopharmaceutical [18F]F-PSMA-1007 with [18F]F- from different external suppliers. A quality agreement has been signed with two different suppliers, and a well-established and correctly implemented quality assurance protocol has been followed. The [18F]F- was produced with cyclotrons, on Nb target, but with different beam energy and current. Extensive validation of the [18F]F-PSMA-1007 synthesis process has been performed. The aim of this paper was the description of all the quality documentation which allowed the submission and approval of the Investigational Medicinal Product Dossier (IMPD) to the Competent Authority, addressing the quality problems due to different external suppliers. The result indicates that no significant differences have been found between the [18F]F- from the two suppliers in terms of radionuclidic and radiochemical purity and [18F]F- impacted neither the radiochemical yield of the labelling reaction nor the quality control parameters of the IMP [18F]F-PSMA-1007. These results prove how a correct quality assurance system can overcome some Regulatory Authorities issue that may represent an obstacle to the clinical use of F-18-labelled radiopharmaceuticals without an on-site cyclotron

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European Union One Health Country Visits as Driver to Combat on Antimicrobial Resistance

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.766 ◽

2020 ◽

Vol 41 (S1) ◽

pp. s222-s222

Author(s):

Pita Spruijt ◽

Paul Bergervoet ◽

Robbin Westerhof ◽

Merel Langelaar ◽

Marie-Cécile Ploy

Keyword(s):

European Union ◽

Antimicrobial Resistance ◽

Peer Review ◽

Infection Prevention ◽

One Health ◽

Competent Authority ◽

Political Agenda ◽

The European Union ◽

Review System ◽

Set Up

Background: In 2016, the European Union adopted unanimously Council Conclusions on the next steps to combat antimicrobial resistance under a One Health approach. To implement some of the provisions laid down in the Council Conclusions, a European Joint Action on Antimicrobial Resistance (AMR) and Healthcare-Associated Infections (HCAI) or EU-JAMRAI was set up, gathering 44 partners. Methods: As part of EU-JAMRAI, 13 participating European countries set up a country-to-country peer review system to evaluate each other’s national action plans (NAPs). This review system entailed a self-assessment, strengths–weaknesses–opportunities–threats (SWOT) analysis, and country visits. All steps were executed with representatives from both the human and the veterinary domains (One Health approach). Special attention was given to supervision and the way supervision can enhance the implementation of guidelines on AMR, both at the policy level and within healthcare institutions. Results: Despite differences in the stage of developing and implementing NAPs, all 13 countries are working on NAPs. In this process, country visits function as a moment to exchange best practices and to provide an outsider’s point of view. At the end of 2019, 13 country-to-country visits had taken place, resulting in tailor-made recommendations for each country. These recommendations were shared with the competent authority. An example is a country that used the recommendation to improve infection prevention as an immediate reason to get the topic on the agenda of the Ministry of Health. During the country visits, intersectoral participation was perceived as desirable, but in some cases it was challenging to arrange. For some highly relevant topics, it has been recognized that discussion should take place on a European level. Examples of such topics include supervision, infection prevention guidelines, funding, surveillance, and regular audits of antibiotic prescriptions for physicians including feedback loops. Conclusions: Peer review is a cooperative and friendly working method compared to common audits. The country visits function as an agenda setting tool to get or to keep AMR on the political agenda and presenting the most relevant topic(s) to address for each country.Funding: NoneDisclosures: None

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