How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth after the COVID-19 Impact

2021 ◽  
pp. 1-6
Author(s):  
Raymond K. Y. Tong
Keyword(s):  
University Students ◽  
Medical Devices ◽  
Market Growth ◽  
Regulatory Affairs

Compression Therapy: European Regulatory Affairs

2000 ◽  
Vol 15 (3-4) ◽  
pp. 182-187 ◽  
Author(s):  
H. A. M. Neumann
Keyword(s):  
Medical Devices ◽  
Medical Profession ◽  
University Hospital ◽  
Residual Pressure ◽  
Elasticity Coefficient ◽  
Compression Stockings ◽  
Durability Test ◽  
Elastic Compression ◽  
Regulatory Affairs ◽  
Custom Made

Objective: Updating the status of the European standardisation for medical elastic compression stockings, including custom-made stockings (class 030606, EN29999), knitted from threads made of natural fibres or synthetic fibres and elastic threads. Design: Review of the literature. Setting: Department of Dermatology at the University Hospital of Maastricht (The Netherlands). Methods: Systematic review of the European regulations within the European Committee for Standardisation (CEN), by a special committee researching non-active medical devices (CEN/TC205). A special working group was set up for medical elastic compression stockings (CEN/TC205/WG2) and for anti-embolism stockings (CEN/TC205/WG2/P1) linked to the scientific background and literature on medical elastic compression stockings. Results: CEN/TC205 formalised a European prestandard (prEN12718) for medical elastic compression stockings. The pre-standard describes five compression classes, instructions for measurement, instructions for residual pressure and instructions for knitting. Still lacking is a good instrument for the comparison of laboratory measurements and a durability test. The problem of the elasticity coefficient is neglected in the standard. Conclusions: Normalisation of non-active medical devices is an important quality instrument. The medical profession should give attention to adequate compression classes, a good understanding of the elasticity coefficient and the durability of stockings.

scholarly journals Is User Experience a suitable goal in the development of medical devices?

2021 ◽  
Vol 7 (2) ◽  
pp. 807-810
Author(s):  
Matthias Reisemann ◽  
Angelina Krupp
Keyword(s):  
User Experience ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Medical Technology ◽  
Consumer Products ◽  
International Standards ◽  
Guiding Principle ◽  
Device Development ◽  
Regulatory Affairs ◽  
Development Processes

Abstract Product development in medical technology is largely governed by Regulatory Affairs. In contrast, for consumer products Human-Centred Design (HCD) is the guiding principle. Both approaches are laid down in international standards and overlap many aspects such as procedure, applied methodologies and development activities. For medical devices patient safety and therefore risk management is the guiding development goal. In HCD the focus lies on User Experience (UX), a positive experience throughout the entire product life cycle. The question arises whether UX could play a more important role in medical device development, particularly considering the similarities of the two development processes

Impact of Advertisements on Demand for Fairness Products Among University Students in Pakistan

2021 ◽  
pp. 2208-2223
Author(s):  
Tansif Ur Rehman ◽  
Sajida Parveen ◽  
Kiran Jawaid ◽  
Muhammad Ajmal Khan
Keyword(s):  
Growth Rate ◽  
University Students ◽  
Repeated Exposure ◽  
Strong Impact ◽  
Buying Behavior ◽  
Market Growth ◽  
On Demand ◽  
Beauty Care ◽  
The Impact ◽  
Product Claim

One of the most important functions of TV advertisements is to create demand for products. TV advertisements influence youth towards buying behavior. The demand of beauty care products is rising in Pakistan and is experiencing high industrial market growth rate. In contemporary era, majority of fairness TV ads exaggerate the product benefits, which often results in rousing an inappropriate demand within the respective market. The repeated exposure (frequency) of advertisement helps to boost demand of products. This research, intended to study the impact of two respective factors, namely, the product claim and the extent of frequency of fairness TV ads. It also finds out which factor has a much stronger influence on demand for fairness products. The major findings of the study revealed that there is a strong impact of fairness TV ads on their demand among university students in Karachi (Pakistan). The TV ads for fairness products holds a lasting impact on the minds of consumers and consequently leads to stimulate their demand.

Clinical Research and Regulatory Affairs

2021 ◽  
pp. 160-184
Author(s):  
Maria Teresa Herdeiro ◽  
Nélia Gouveia ◽  
Fátima Roque
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Devices ◽  
Clinical Studies ◽  
Market Access ◽  
Systems Of Care ◽  
Therapeutic Interventions ◽  
Knowledge And Skills ◽  
Regulatory Affairs ◽  
Before And After

Clinical research is a large umbrella, and it mainly includes the implementation of clinical studies/trials. This field is crucial to assess the value of new developments in healthcare, be it new therapeutic interventions, medical devices, or systems of care. In order to protect human rights, the implementation of clinical trials is complex and extremely costly. In this context, medicines and medical devices are strongly regulated products before and after the market authorization. So during their training, pharmacists must develop skills in the area of regulatory affairs, design and methodology of clinical trials, and other clinical studies, as well as in the management of clinical projects to be prepared for the challenges of the clinical research and market access processes. With that purpose, knowledge and skills for clinical research should be developed in association with regulatory affairs.

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

2013 ◽  
Vol 1 (1) ◽  
pp. 1-4
Author(s):  
Jitendra Kumar Badjatya
Keyword(s):  
Quality Of Life ◽  
Pharmaceutical Industry ◽  
Medical Devices ◽  
Legal Aspects ◽  
Pharmaceutical Products ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Pharmaceutical Drug ◽  
Regulatory Affairs

Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.

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