The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments

2021 ◽  
pp. 19-26
Author(s):  
Fredrik Dalborg
Keyword(s):  
1984 ◽  
Vol 3 (2) ◽  
pp. 125-128
Author(s):  
Patricia D. Royal

The enactment of the FDA Good Laboratory Practices (GLPs) into law by the FDA has led to major changes throughout industrial toxicology programs. One major addition to toxicology studies, as specified in the GLPs, includes the requirement of a quality assurance (QA) program. Initially, the role of QA was that of monitor or auditor. This role has expanded in a practical sense, however, to include a working knowledge of regulatory affairs and principles of toxicology. Since 1978, new GLPs and test standards have been issued by several countries, including the United States. The requirements and guidelines set forth by various countries, while similar in content, are different in their specific details. The development of comprehensive, scientifically sound protocols to meet these new requirements necessitates a continual assessment of the regulations in effect in the countries where registration is sought. Thus, the role of QA has expanded to include the assessment of guidelines and protocols to assure that toxicology studies conducted to support registration are in compliance with these guidelines.


2012 ◽  
Vol 82 (5) ◽  
pp. 360-364
Author(s):  
Jeffrey B. Blumberg

The insights gained from the last 100 years of vitamin research and applications have contributed substantially to our fundamental understanding of biology and importantly to the promotion of human health. There is no reason to think that the next 100 years will be any less fruitful if we are committed to preparing for them, particularly by changing four critical nutrition paradigms. First, we must move beyond the concept of preventing vitamin deficiencies and inadequacies to establishing health and, further, to creating optimal physiological functions. Each essential vitamin possesses different concentration thresholds for its variety of effects and the required balance necessary to achieving each has yet to be fully defined. Second, we must apply the research approaches and methods of “-omics,” systems biology, and imaging technologies to define the dynamic role of vitamins and their broad array of genomic, molecular, biochemical, and functional interactions. Such work is necessary to understand the multiplicity of vitamin actions and ultimately apply them directly at the level of the individual. Third, we must revise the concept of evidence-based nutrition away from its current hierarchical system to recognize in a comprehensive and integrated way the attributes of each type of approach to research. To adhere to a single gold standard of the randomized clinical trial ignores both how we have moved forward so productively during the last 100 years and the vital information to be gained from basic research and other human studies; further, it acts to stifle innovation in both scientific and regulatory affairs. Fourth, we must understand that changes in the supply and distribution of food during the next century are likely to be at least as dramatic as those which have occurred over this last one. For example, inevitable environmental constraints will require more food protein be derived from plant than animal sources, a shift that will directly impact the dietary sources for vitamins. To meet the challenge of achieving global health in 2113 among a population of 9 billion people, effectively managing these four changes demands new and creative ways in which those in academia, government and non-government organizations, and industry must work together.


2014 ◽  
Vol 39 (7) ◽  
pp. 754-762 ◽  
Author(s):  
Bruce Holub ◽  
David M. Mutch ◽  
Grant N. Pierce ◽  
Delfin Rodriguez-Leyva ◽  
Michel Aliani ◽  
...  

The science of lipid research continues to rapidly evolve and change. New knowledge enhances our understanding and perspectives on the role of lipids in health and nutrition. However, new knowledge also challenges currently held opinions. The following are the proceedings of the 2013 Canadian Nutrition Society Conference on the Advances in Dietary Fats and Nutrition. Content experts presented state-of-the-art information regarding our understanding of fish oil and plant-based n-3 polyunsaturated fatty acids, nutrigenomics, pediatrics, regulatory affairs, and trans fats. These important contributions aim to provide clarity on the latest advances and opinions regarding the role of different types of fats in health.


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