Drug Safety: The Role of Regulatory Authorities

2002 ◽  
Vol 29 ◽  
pp. 47-49
Author(s):  
Hans-Joachim Meencke
Keyword(s):  
Drug Safety ◽  
Regulatory Authorities

HUMANIZATION OF INFORMATION SPACE IN THE ASPECT OF ENSURING THE BIOLOGICAL, FOOD AND NUTRITION SECURITY OF THE COUNTRY

10.12737/7759 ◽  
2014 ◽  
Vol 9 (4) ◽  
pp. 73-75
Author(s):  
Юнусов ◽  
Rauf Yunusov
Keyword(s):  
Information Technology ◽  
Food Security ◽  
The State ◽  
Information Space ◽  
Food And Nutrition Security ◽  
Nutrition Security ◽  
Regulatory Authorities ◽  
Role Of The State ◽  
Food And Nutrition

The article presents the importance of information technology in the biological and food security of the country. It reveals the role of the state federal regulatory authorities in its provision.

Quality not quantity: Key success factors from the first decade of safety reports from the Research on Adverse Drug Events and Reports project (RADAR)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6559-6559
Author(s):  
C. Bennett ◽  
B. J. Edwards ◽  
C. C. Tigue ◽  
D. W. Raisch ◽  
D. M. Courtney ◽  
...  
Keyword(s):  
Drug Safety ◽  
Success Factors ◽  
Adverse Drug Events ◽  
Case Reports ◽  
Signal Generation ◽  
Drug Reactions ◽  
High Quality ◽  
Key Success Factors ◽  
Safety Signals

6559 Background: RADAR is the only independent academic pharmacovigilance organization funded exclusively by peer-reviewed grants. We describe the role of high quality case reports in the detection of drug safety signals. Methods: RADAR has identified 11 cancer-related adverse drug reactions (ADRs). Initial reports for small numbers of cases were obtained from our own institution, NU, (4 ADRs) or from referral centers (7 ADRs). Clinicians at these centers voluntarily provided brief case reports to RADAR, who submitted detailed case reports to the FDA/manufacturer. Clinicians were promised that patient/provider data would be kept confidential and that these data would be submitted as peer-reviewed manuscripts. Results: See Table. Conclusions: RADAR was successful at signal generation and amplification because it focused on quality, not quantity of case reports. Pharmacovigilance efforts that allow clinicians to complete brief forms, maintain confidentiality of patient and provider, and result in submission of collaborative manuscripts may improve early detection of drug safety signals initiatives in oncology. [Table: see text] No significant financial relationships to disclose.

scholarly journals Role of Pharmacy in the Promotion of Drug Safety in Pharmacotherapy

2018 ◽  
Vol 138 (2) ◽  
pp. 149-150
Author(s):  
Mitsutoshi Satoh
Keyword(s):  
Drug Safety

scholarly journals The State-based Financial Control in Ukraine: Status and Directions for Improvement

2021 ◽  
Vol 10 (525) ◽  
pp. 336-340
Author(s):  
I. V. Yahodenko ◽  
◽  
O. D. Hordei ◽  
Keyword(s):  
The State ◽  
Current Status ◽  
Financial Control ◽  
Theoretical Understanding ◽  
Regulatory Authorities ◽  
Control Functions ◽  
Role Of The State ◽  
Definition Of ◽  
Effective Use

The article is aimed at disclosing the economic essence of the concept of «the State-based financial control», defining and analyzing the current status of the State-based financial control in Ukraine. The article analyzes the opinions of scholars on the definition of the conceptual apparatus of the research topic and derives a theoretical understanding of the State-based financial control. The issue of building an effective unified system of the State-based financial control is researched. The analysis of legislation norms on the implementation of the State-based financial control is carried out. The opinions of leading scholars who study the problems of control over the effective use of both the State and the local budgets together with reforms in this area are taken into account. The current status of the State-based financial control in the country is analyzed, a number of problems within the system are outlined. The characteristic shortcomings of functioning of the elements of the State-based control system are outlined (absence of a unified concept for the development of the State-based financial control, deepening of the powers of regulatory authorities, presence of a large number of normative legal acts, their outdatedness and inconsistency), the inadmissibility of duplication of control functions is emphasized. The role of the State-based audit in the formation of the successful State-based financial control in the country is determined. The risks that influence the formation of the State-based financial control are analyzed. It is concluded that the system of the State-based financial control in Ukraine does not have sufficient legal, informational, organizational, communicative, institutional and methodological provision that would meet the modern challenges of the country’s economy. Solving the problems of organization and functioning of the State-based financial control is possible by systematically improving the activities of financial control bodies, increasing the level of audit and continuous improvement of the management system within the organizations of regulatory authorities.

scholarly journals Drug Safety Monitoring—International Information

2020 ◽  
Vol 8 (4) ◽  
pp. 211-213
Author(s):  
E. V. Shubnikova ◽  
T. M. Bukatina ◽  
G. V. Kutekhova
Keyword(s):  
Drug Safety ◽  
Patient Information ◽  
Safety Monitoring ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Patient Information Leaflets ◽  
Regulatory Authorities ◽  
Information Leaflets ◽  
Drug Safety Monitoring

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on limiting the use of some medicinal products and/or the need to introduce changes in patient information leaflets due to changes in the medicines’ safety profiles. The analysis helped to identify 16 administrative decisions that contain information on the following medicines registered in Russia: duloxetine, sertraline, paroxetine, сitalopram, desvenlafaxine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, venlafaxine, vortioxetine, mirtazapine, risperidone, clozapine, aripiprazole, quetiapine, olanzapine, lacosamide, gabapentin, pregabalin. 

scholarly journals THE EFFECT OF POLICIES OF THE RBI ON ISSUING NEW BANK LICENCES FROM POST NATIONALISATION OF BANKS IN INDIA

2021 ◽  
pp. 29-36
Author(s):  
Dr.K.Thirumamagal
Keyword(s):  
Private Sector ◽  
Central Bank ◽  
Regulatory Authority ◽  
The Other ◽  
Innovative Technology ◽  
Paper Study ◽  
Economic Stability ◽  
Regulatory Authorities ◽  
The World

In this modern scenario, Finance has become the foremost basic necessity in order to acquire the other necessities of life. The prominent financial sector are regulated by different regulatory authorities with a prime motto of protecting the interest of the customers and to uplift the weaker sections of the society. Since this strife-torn world is full of conflicts, corruption which has affected the economic stability of the state, the regulatory authorities should seriously analyze the effect of licenses going to be provided in 2014 and also it has to take in to account that the empires down the history have been known to get built only to be lost subsequently. The objective of this study is to impart the essential standards the banks of India should possess and also the challenges going to be faced by our economy due to the reckless decision of the regulatory authority. The need of this study is to safeguard the customers of us from the unscrupulous businessmen. This paper study the role of central bank and to analyze the result of providing license to the private sector, particularly the corporate houses, which is not practiced anywhere in the world. KEY WORDS: Corporates, Banks, Finance, Non Performing Asset, innovative, technology, Licenses, RBI

scholarly journals Assessing Drug Safety in Children — The Role of Real-World Data

2018 ◽  
Vol 378 (23) ◽  
pp. 2155-2157 ◽  
Author(s):  
Ann W. McMahon ◽  
Gerald Dal Pan
Keyword(s):  
Drug Safety ◽  
Real World ◽  
Real World Data ◽  
World Data
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