Regulations and Guidelines for Therapeutic Approval of Investigatioanl Drugs

Yakhak Hoeji ◽  
2021 ◽  
Vol 65 (6) ◽  
pp. 441-452
Author(s):  
Nayoung Park ◽  
Serim Min ◽  
Young Hu Shon ◽  
Jin Hyun Nam ◽  
Sun-Hong Kwon
2020 ◽  
Author(s):  
Dr. Priyanka Jaiswal ◽  
Dr. Ved Prakash Mishra ◽  
Dr. Minal Chaudhary ◽  
Dr. Sunita Vagha ◽  
Dr. Sachin Damke ◽  
...  

UNSTRUCTURED DattaMeghe Institute of Medical Sciences has been declared as Deemed to be University [DMIMS (DU)] under section 3 of UGC Act, 1996 in the year 2005. The University examinations are conducted as per the rules, regulations and guidelines issued by the various Apical councils of India from time to time. The first University exam was conducted in the year 2006. DMIMS (DU) has initiated various reforms by its own in assessment and evaluation process based on needs. For any system to thrive, it needs to be constantly upgraded and critically evaluated. Therefore, a study is undertaken with this in mind and thereby aimed at evaluation and validation of the assessment and evaluation reforms formulated and implemented at DMIMS (DU) since its inception (year 2006).Need analysis for the assessment and evaluation reforms will be carried out on the basis of feedbacks and reports received from respective stakeholders (Students, Faculty and External examiners) from time to time. Outcome analysis of the Feedbacks and reports will be done subsequently after the implementation of the assessment and evaluation reforms. Further based on the outcome analysis, reforms will be validated into following parameters: Objectivity, Responsiveness, User friendliness, Residual component (not covered in above 3 parameters)and a satisfactory index will be derived. If satisfactory index for reform is 100%, it will be concluded that reforms are well received and good to excellent in nature. Total 33 assessment and evaluation reforms have beenimplemented since year 2006. These reforms will be categorised into Pre-Examination (n=18), On Site Examination (n=05) and Post Examination (n=10), and in each category, they will befurther classified into academic (Total =15) and administrative (Total = 18) on the basis of their domain for the ease of structuring and implementation.All the 33 reforms will be validated on the basis of defined parameters. They will be found satisfactory.


Author(s):  
Christina Lindemer ◽  
Jeffrey Gangai ◽  
Christopher Mack ◽  
Elena Drei-Horgan ◽  
Darryl Hatheway

Flood Insurance Studies (FISs) produced by the Federal Emergency Management Agency (FEMA) per the National Flood Insurance Program (NFIP) regulations and guidelines adopt storm-induced erosion criteria often called the “540 rule”. The methods used in the erosion analysis have been in place since the 1980s. The method requires dunes to be classified as fully eroded, or “removed”, when their cross-sectional reservoir is smaller than 540 square feet. Since the rule’s first application, additional data and recent evidence have become available leading FEMA to identify this approach as an area of the program in need of updating and improvement. Experts involved in conducting coastal hazard analyses for FEMA studies recommend exploring opportunities to improve FEMA guidelines for erosion criterion and revise NFIP regulations and guidance, as needed, to ensure that storm-related erosion hazards are appropriately evaluated and mapped along US coastlines.


2019 ◽  
Vol 4 (1) ◽  
pp. 168-170
Author(s):  
Wan Farahiyah Izni Binti W Abd Rahman

The Umrah is an Islamic pilgrimage to holy cities of Makkah and Madinah and is performed by Muslims that can be undertaken at any time of the year. The number of registered Malaysian Umrah pilgrims continued to increase annually. However, there are many complaints reported in the Tribunal for Consumer Claims in relation to this service. The aim of the article is to analyse the extent to which the relevant laws protect the rights of Umrah consumers in Malaysia. Being qualitative in nature, this study collects relevant framework which includes laws, regulations and guidelines which are related to Umrah services. The purpose is to analyse the adequacy of the existing consumer protection laws in protecting Umrah pilgrims. The result of the study indicated that in Malaysia, the existing laws are inadequate to provide a comprehensive protection to the Umrah pilgrims. This study proposes improvement to the existing laws so that it will be able to provide adequate protection to the Umrah pilgrims.


Author(s):  
Anona Armstrong

One of the fascinating questions of our time is why, when so much effort has gone into implementing corporate governance guidelines and raising the awareness of business ethics, stories of unethical conduct and poor governance continue to emerge on the front pages in our newspapers. Around the world financial scandals continue to occur and each time seekers of an antidote to the latest disaster call for more governance. This was evident after the 1987 securities market collapses when the Cadbury Committee and the OECD (Cadbury 1992; OECD 1999) were among many organisations which were to introduce governance regulations and guidelines over the next decade, and it is again prominent today.


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