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.

scholarly journals Analytical Quality by Design

2021 ◽  
Vol 8 (32) ◽  
pp. 1-5
Author(s):  
Márcia Breitkreitz
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Pharmaceutical Products ◽  
Quality Parameters ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Significant Step ◽  
Level Of Understanding ◽  
High Level

Throughout the 20th century, the notion of ‘quality’ underwent major changes. The concept of ‘Quality by Testing’, i.e. evaluating the quality of a product by testing it for some pre-defined parameters after completing the manufacturing process, started to be replaced by the enhanced approach of Quality by Design (QbD). In this concept, idealized by Joseph Juran [1], quality is initially conceived for the product, and then the product is manufactured and evaluated to reach that quality. Driven by the need to reduce costs and to encourage companies to improve their understanding of their products and manufacturing processes, pharmaceutical regulatory agencies, through the ICH (International Council on Harmonization), published the ICH Q8 guideline, highlighting the QbD strategy for pharmaceutical development [2]. This represented a significant step in replacing the existing quality paradigms in the conventional manufacturing of pharmaceutical products and paved the way to support development and production activities within a scientific, flexible environment, with a high level of quality, without the need for extensive regulatory surveillance. The higher level of understanding gained during development allows out-of-specification batches to be foreseen and ensures that the desired quality will be obtained at the end of the manufacturing process. The two pillars of the QbD concept are quality risk management and multivariate study of the outcomes (quality parameters) as functions of the inputs (materials, formulation and process inputs). At this point, Chemometrics emerged officially as a strategy to support the pharma regulatory requirements- the beginning of a joyful and long-life union.

Medical technology: A systematic review on medical devices utilized for epilepsy prediction and management

2021 ◽  
Vol 19 ◽  
Author(s):  
Jen Sze Ong ◽  
Shuet Nee Wong ◽  
Alina Arulsamy ◽  
Jessica L. Watterson ◽  
Mohd. Farooq Shaikh
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Medical Devices ◽  
Epileptic Seizures ◽  
Well Being ◽  
Sudden Unexpected Death ◽  
Unexpected Death ◽  
Long Time ◽  
Wearable Medical

: Epilepsy is a devastating neurological disorder that affects nearly 70 million people worldwide. Epilepsy causes uncontrollable, unprovoked and unpredictable seizures that reduces the quality of life of those afflicted, with 1-9 epileptic patient deaths per 1000 patient occurring annually due to sudden unexpected death in epilepsy (SUDEP). Predicting the onset of seizures and managing them may help patients from harming themselves and may improve their well-being. For a long time, electroencephalography (EEG) devices have been the mainstay for seizure detection and monitoring. This systematic review aimed to elucidate and critically evaluate the latest advancements of medical devices, besides EEG, that have been proposed for the management and prediction of epileptic seizures. A literature search was performed on three databases; PubMed, Scopus and EMBASE. Following title/abstract screening by two independent reviewers, 27 articles were selected for critical analysis in this review. These articles revealed ambulatory, non-invasive and wearable medical devices such as the in-ear EEG devices, the accelerometer-based devices and the subcutaneous implanted EEG devices might be more acceptable than traditional EEG systems. In addition, extracerebral signal-based devices may be more efficient than EEG-based systems, especially when combined with an intervention trigger. Although further studies may still be required to improve and validate these proposed systems before commercialization, these findings may give hope to epileptic patients, particularly those with refractory epilepsy, to predict and manage their seizures. The use of medical devices for epilepsy may improve patients' independence and quality of life and possibly prevent sudden unexpected death in epilepsy (SUDEP).

Some statistical considerations in the development of new quality of life (QoL) scales in schizophrenia

1998 ◽  
Vol 13 (3) ◽  
pp. 154-157 ◽  
Author(s):  
J McKellar
Keyword(s):  
Quality Of Life ◽  
Pharmaceutical Industry ◽  
Study Design ◽  
The Right ◽  
Study Designs ◽  
Over Time

SummaryAssessing the effect of novel pharmaceutical treatments on the quality of life (QoL) of a patient, or group of patients, has been approached in numerous ways over the last 20 years. Techniques as diverse as single questions to multidimensional scales requiring trained assessors to devote several hours to each assessment; from generic questions about how life might have changed to specific issues such as the ability to use a toothbrush. In the pharmaceutical industry, the emphasis is on the registration of a product with national licensing bodies. Each body has tended to see the issue from a different perspective, which has driven study designs to be different in different countries; even different over time within one country. This paper emphasises the basic statistical steps necessary to ensure that a measure of QoL is appropriately recorded, while retaining sufficient flexibility to support the registration in several countries. Aspects about possible study design are included to assist with developing some simple concepts about analysing and then interpreting the results. It is not the intention of the paper to provide the answer, merely to provide the tools to develop the answer robustly. Put briefly, with the right approach generic solutions are feasible and these solutions will have greater utility. The challenge is to recognise exactly what QoL is, and not to deviate from it.

scholarly journals Prosthetics in complex medical and social rehabilitation of patients with ocular pathology

2016 ◽  
Vol 19 (4) ◽  
pp. 182-185 ◽  
Author(s):  
Elena N. Verigo ◽  
P. V Makarov
Keyword(s):  
Quality Of Life ◽  
Legal Aspects ◽  
Social Adaptation ◽  
Occupational Activity ◽  
Ocular Prosthesis ◽  
Ocular Pathology ◽  
Social Rehabilitation ◽  
Analysis Of Results

There is presented an analysis of results of observations in patients underwent different ocular prosthetic procedures: 152 patients with keratoprosthesis; 5456 cases with congenital or acquired anophthalmia, microphthalmus and ocular subatrophy with ocular prosthesis and 63 patients with ecto prosthesis. There are considered clinical, organization and legal aspects of indications for different prosthetic procedures, possible complications and their prevention. There was determined the role ofprosthetics in rehabilitation and medico-social adaptation in patients with severe ocular pathology which helps to improve the quality of life and rehabilitation ofpatients in dependence on their age, kind of the occupational activity and psychosomatic state.

EMEA and the evaluation of health-related quality of life data in the drug regulatory process

2004 ◽  
Vol 20 (3) ◽  
pp. 311-324 ◽  
Author(s):  
Sotiria Papanicolaou ◽  
David Sykes ◽  
Elias Mossialos
Keyword(s):  
Quality Of Life ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
Regulatory Process ◽  
Health Related Quality ◽  
Medicinal Products ◽  
Hrqol Data ◽  
Related Quality ◽  
Health Related

Objectives:This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process.Methods:All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations.Results:Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR.Conclusions:A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.

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