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  • RAPS' LatestRAPS' Latest

    RAPS Releases Results of Compensation Survey of Regulatory Professionals

    RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved. RAPS’ 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2,300 respondents from 64 countries and breaks down median and averag...
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    RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role Compensation Up

    RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession , which can be downloaded at www.RAPS.org/sop . Among the most significant findings, r...
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    RAPS Launches Global Survey of Regulatory Professionals' Work and Compensation

    RAPS has just launched its biennial global survey of regulatory professionals who work with healthcare and related products. RAPS’ Scope of Practice & Compensation Survey of the Regulatory Profession , conducted every two years, is the largest and most comprehensive survey of professionals in this important field, vital to ensuring healthcare products are safe and effective. Respondents work in the pharmaceutical, biotechnology and medical device industries, governme...
  • Regulatory NewsRegulatory News

    Health Canada Clarifies Compensation Package for Thalidomide Victims

    For the second time in history, the Canadian government will provide compensation to victims of the infamous drug Thalidomide. Background Thalidomide was originally marketed in several countries as a morning sickness drug by Chemie Grünenthal in the late 1950s and early 1960s until its use was linked to thousands of deaths and birth defects. Approximately half of the surviving infants who were exposed to Thalidomide in the womb suffer from malformed limbs. The drug al...
  • Regulatory NewsRegulatory News

    India Issues Final Rule on Compensating Clinical Trial Deaths

    India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject.  Under the amended rules, which took effect on 30 May 2014, an Independent Expert Committee will examine the report of the death and make a recommendation within 30 days to the CDSCO as to t...
  • CDSCO Releases Draft Formula for Clinical Trial Injury Compensation

    India's Central Drugs Standard Control Organization (CDSCO) has issued a call for comments on its new formula for determining compensation for patients injured in clinical trials. According to the draft, Draft Formula to Determine the Quantum of Compensation in Case of Clinical Trial Related Injury (Other Than Death) , in cases of Serious Adverse Events (SAE) other than death, the CDSCO will determine the cause of injury and decide the amount of compensation. The reg...
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    Survey of Regulatory Pros Draws Increasingly Global Response

    RAPS' biennial research survey of the regulatory profession, launched at the end of January and continuing through Monday, 31 March, has garnered well over 2,000 responses to date, with 29% from outside the US. The Global Scope of Practice & Compensation Survey has been conducted by RAPS for nearly 25 years, and it continues to be the largest, most comprehensive study of the healthcare products regulatory profession. Increasingly, survey responses are coming from p...
  • RAPS' LatestRAPS' Latest

    RAPS Launches Global Survey of Regulatory Professionals

    • 28 January 2014
    RAPS today launched the 2014 Scope of Practice &Compensation Survey of the Regulatory Profession , a survey of professionals around the world-both RAPS members and nonmembers-who are involved with the regulatory process for healthcare products. The survey asks regulatory professionals working in the pharmaceutical, biotechnology and medical device industries; regulatory agencies; academia, consultancies and other settings about their jobs, backgrounds and compensati...
  • India Releases Clinical Trial Adverse Event Compensation Formula

    India's Central Drugs Standard Control Organization (CDSCO) has issued a "provisionally final" formula to be used in determining the amount of compensation that a clinical trial sponsor must pay a clinical trial subject for an adverse event or death related to the trial.  According to the formula, the compensation amount for an adverse event or death would vary from a minimum of Rs.4 lacs (approximately $6,300 to a maximum of Rs.73.60 lacs (approximately $1,...
  • India's Health Ministry Releases New Clinical Trials Requirements

    India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics. Background India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country ...
  • New Rules Set to Overhaul Indian Clinical Trials Framework

    Indian regulators are out with two new clinical trials regulations that promise to reform some of the ethical hurdles that had plagued the sector in the past, including lax approval standards and a lack of compensation for injured participants. Compensation On 30 January 2013, India's Ministry of Health issued final regulations governing compensation for clinical trial injury or death, roughly a year after the draft regulations were released for public comment.  ...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...