scholarly journals PNS138 TRANSNATIONAL COLLABORATIONS AMONG DRUG REGULATORY AGENCIES: TRENDS AND FUTURE PERSPECTIVES

2019 ◽  
Vol 22 ◽  
pp. S785
Author(s):  
A. Vladimirova ◽  
C. Rémuzat ◽  
M. Toumi
Keyword(s):  
Regulatory Agencies ◽  
Future Perspectives ◽  
Drug Regulatory Agencies

Pharmacovigilance

2013 ◽  
pp. 1453-1473
Author(s):  
Jimmy Jose
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Drug Safety ◽  
Health Care Professionals ◽  
Regulatory Agencies ◽  
Major Influence ◽  
Design Development ◽  
Hospital Perspective ◽  
Basic Concepts ◽  
Drug Regulatory Agencies

Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. It is important to understand the basic concepts related to Adverse Drug Reactions (ADRs): epidemiology, classification, predisposing factors, evaluation parameters, and surveillance methods. Pharmacovigilance is defined as the science and activities relating to the detection, evaluation, understanding, and prevention of ADRs or any other drug-related problems. It involves patients, medical professionals, the pharmaceutical industry, drug regulatory agencies, and academic scientists. Pharmacoinformatics, the application of information technology with regard to the drug design, development, and drug use has played a major role in the appropriate implementation of pharmacovigilance at industry, regulatory, and hospital levels. The functioning of international regulatory agencies and drug safety departments of pharmaceutical industries has been greatly influenced by pharmacoinformatics. Pharmacoinformatics has changed the way in which health care is practiced. Modern information technology can be used by health care professionals for various purposes and, thereby, make a substantial contribution to optimize the quality of medication use in institutions with due importance of safety. Pharmacoinformatics has a major influence in the development of pharmacogenetics and its individual applications including improving drug safety. Pharmacoinformatics will play a major role in the future development and practice of pharmacovigilance. The present chapter is aimed at providing the readers an insight into the importance and basic concepts of pharmacovigilance, and the process involved in it. Application of pharmacoinformatics in improving drug safety at various levels from an industry, regulatory and hospital perspective is discussed.

Do homeopathic medicines provoke adverse effects? A systematic review

2000 ◽  
Vol 89 (S 01) ◽  
pp. S35-S38 ◽  
Author(s):  
F Dantas ◽  
H Rampes
Keyword(s):  
Systematic Review ◽  
Adverse Effects ◽  
Methodological Quality ◽  
Case Reports ◽  
Regulatory Agencies ◽  
High Dilutions ◽  
Quality Of Reports ◽  
The Mean ◽  
Drug Regulatory Agencies

AbstractObjective: To evaluate the safety of homeopathic medicines by critically appraising reports of adverse effects published in English from 1970 to 1995.Method: Systematic review on information regarding adverse effects of homeopathic medicines identified using electronic databases, hand searching, searching reference lists, reviewing the bibliography of trials, and other relevant articles, contacting homeopathic pharmaceutical companies and drug regulatory agencies in UK and USA, and by communicating with experts in homeopathy.Results: The mean incidence of adverse effects of homeopathic medicines was greater than placebo in controlled clinical trials (9.4/6.1) but effects were minor, transient and comparable. There was a large incidence of pathogenetic effects in healthy volunteers taking homeopathic medicines but the methodological quality of these studies was generally low. Anecdotal reports of adverse effects in homeopathic publications were not well documented and mainly reported aggravation of current symptoms. Case reports in conventional medical journals pointed more to adverse effects of mislabelled ‘homeopathic products’ than to true homeopathic medicines.Conclusions: Homeopathic medicines in high dilutions, prescribed by trained professionals, are probably safe and unlikely to provoke severe adverse reactions. It is difficult to draw definite conclusions due to the low methodological quality of reports claiming possible adverse effects of homeopathic medicines.

scholarly journals Overview of post marketing aggregate reports and global regulatory requirements

2017 ◽  
Vol 3 (12) ◽  
pp. 300
Author(s):  
Paramaguru Rathinavelsamy
Keyword(s):  
Medicinal Product ◽  
Safety Information ◽  
Individual Case ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Safety Feature ◽  
Regulatory Submissions ◽  
Post Marketing ◽  
Risk Balance ◽  
Drug Regulatory Agencies

Pharmacovigilance is the science that deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of pharmacovigilance has evolved over time. We now recognize the importance of a systematic approach for monitoring and improving the safe use of medicines. At the level of individual case safety reports, it is not possible for marketing authorization holders (MAH) to evaluate benefit/risk ratio profile and understand the detailed safety feature of a medicinal product. In addition to submission of individual case safety reports MAH also review periodically, cumulative safety information attained from various sources and submit the findings as aggregate reports to drug regulators. Aggregate reporting is a vital tool to study benefit/risk balance of a medicinal product throughout the product’s life cycle. The timelines, frequency and exact type of aggregate report required to be submitted for the approved product varies globally amongst various drug regulatory agencies. In this review the significance, background, objectives, scope, structural components, timelines for regulatory submissions of post marketing aggregate reports viz. PSUR, PBRER, and PADER have been discussed.

Currents in Contemporary Ethics

2004 ◽  
Vol 32 (2) ◽  
pp. 365-368 ◽  
Author(s):  
Timothy Caulfield ◽  
Trudo Lemmens ◽  
Douglas Kinsella ◽  
Michael McDonald
Keyword(s):  
Clinical Trials ◽  
Conflicts Of Interest ◽  
New Products ◽  
Prescribing Patterns ◽  
Consent Process ◽  
Regulatory Agencies ◽  
Inclusion Criteria ◽  
Community Based ◽  
Funded Research ◽  
Drug Regulatory Agencies

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns.

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