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  • RAPS' LatestRAPS' Latest

    GSK's Sue James Praises RAPS' Regulatory Competency Framework

    In 2016, RAPS released its Regulatory Competency Framework , a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations began using the Framework immediately. We spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and how it has been used at GSK. Regulatory Focus : What do you see as th...
  • Regulatory NewsRegulatory News

    WHO Releases Draft Medical Device Regulatory Framework

    The World Health Organization (WHO) is seeking input on its newly developed regulatory framework for medical devices and in vitro diagnostics (IVDs). The framework, which establishes a common global model for regulating devices and IVDs and provides countries with a two-phased path to implementation, was released for public comment in May. WHO began its work developing the framework in 2015 after the World Health Assembly (WHA) adopted Resolution WHA67.20 ,...
  • RAPS' LatestRAPS' Latest

    RAPS' New Regulatory Competency Framework Helps Organizations, Individuals Plan Professional Development, Training, Career Advancement

    RAPS has released its new Regulatory Competency Framework , a tool to help design training and map professional and career development plans for regulatory professionals. The one-of-a-kind Framework is beneficial for individual professionals as well as regulatory employers and academics developing curriculum and education. The Framework was previewed during last October’s 2015 Regulatory Convergence conference. In his opening remarks, then-RAPS Chairman Rainer ...
  • Regulatory NewsRegulatory News

    BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

    Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. Background The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA has begu...
  • Regulatory NewsRegulatory News

    How do you Weigh Benefits and Risks in Medical Device Trials? FDA Guidance Explains

    Which factors should medical device manufacturers take into account when trying to determine whether an investigational device is suitable to begin testing in humans? The US Food and Drug Administration (FDA) has some thoughts on the matter, contained within a new draft guidance document released on 17 June 2015. Background The guidance, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs) , relates t...
  • New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees

    The US Food and Drug Administration (FDA) would see much of its proposed plan for a national compounding framework adopted under a new plan released Friday by US legislators. Background In the wake of a major compounding scandal last year, FDA's Margaret Hamburg issued a new proposal that she said was geared toward making sure that compounded products manufactured in the US are safe and effective and-critically-manufactured to appropriate standards. "FDA believes that ...
  • FDA Looks to Registries and New Adverse Event Reporting Systems to Improve Device Safety

    US medical device regulators may be getting a lot of attention of their new proposals to finalize a unique device identification (UDI) rule, but four other proposals will be critical as well in the US Food and Drug Administration's (FDA) attempts to build a national postmarket surveillance system, says a new agency report. Background Numerous issues associated with medical devices in recent years have highlighted the importance of developing new ways to keep track of me...
  • European Commission Releases Harmonized UDI Framework

    The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country in line with similar proposals since released by the US Food and Drug Administration (FDA) and under consideration by the International Medical Device Regulators' Forum. Background A UDI is essentially an identifying mark by which someone-particularly a regulatory authorit...
  • FDA Publishes New Benefit-Risk Paradigm Framework, Rejects Quantitative-Only Approach

    The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only approach to regulation as counterproductive to its goals to make the decision-making process as clear and predictable as possible. Background The plan, published on 5 March 2013, notes that FDA's mission calls for it to approve drugs that are both safe and effective. But the ...
  • Australian, New Zealand Regulators Lay Out Framework for New Regulatory Agency

    The governments of Australia and New Zealand have jointly released a new policy paper establishing the proposed framework for the planned future merger of their two healthcare product regulatory agencies-the Therapeutic Goods Administration (TGA) of Australia and New Zealand's Medsafe-into the Australia New Zealand Therapeutic Products Agency (ANZTPA). The paper, released 8 January 2013, is intended to be "the start of a conversation with stakeholders," regulators explai...
  • Australia Clarifies Transitional Requirements for Biologicals

    In May 2011 Australia's Therapeutic Goods Administration (TGA) put in place a  Biologicals Regulatory Framework  to assess and regulate human tissue-based products.  Until then, those products were either not regulated, regulated as drugs or devices, or exempt from certain parts of the Therapeutic Goods Act . As part of the three year transition period, the TGA yesterday issued a  notice  to sponsors of biologicals that are currently supplied in...
  • EMA Opens Consultation on Proposed Pediatric Development Framework

    The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO). The report, " Concept paper on the involvement of children and young people at the PDCO ," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into ...