• Regulatory NewsRegulatory News

    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

    RAPS' long-running Executive Development Program , which brings rising regulatory leaders to the Kellogg School of Management at Northwestern University for four days of intensive business training, has been consistently popular because it fills an increasing need. Most regulatory professionals come from science- or engineering-oriented backgrounds, with relatively few having had business training or experience. The growing recognition of the strategic importance of regu...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...
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    Why Regulatory Professionals Need Business Training

    You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk-free regulatory path to approval, right? Unfortunately, that is not the case. The regulatory development path is typically much more complex and there are many business factors that drive the ultimate development strategy design. The most successful development programs tak...
  • Regulatory NewsRegulatory News

    Trump Pledges to Gut FDA: Which Regulations Need to Go?

    With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house. And before this dive into what FDA might or even could do following the signing of this EO , it is important to remember a constant refrain from all experts Focus spoke with: FDA codifies stat...
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    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...
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    RAPS Appoints Paul Brooks as Next Executive Director

    • 11 August 2016
    RAPS today announced that Paul Brooks has been appointed executive director. Brooks will officially join RAPS on 12 September 2016. He succeeds Sherry Keramidas, who retired last January after 20 years at RAPS. Brooks served on the RAPS board of directors from 2008 through 2013, and was chairman in 2013. He has been actively involved with RAPS as a volunteer representative and leader for two decades. “After a thorough search, the board of directors unanimously ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
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    RAPS Releases Position Specification for New Executive Director

    RAPS has taken the next step in its search for a new executive director , releasing the position specification , which details the qualifications, responsibilities and competencies required of potential candidates. RAPS' board of directors and its executive director search committee worked with executive search firm Russell Reynolds Associates (RRA) to develop the specification. The full position specification document is available online or by contacting RRA...
  • Regulatory NewsRegulatory News

    FDA Warns Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures

    Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs. The warning letter is for the company’s Massachusetts site, which opened in 2012, and details how the company consistently avoided FDA requests for more than a year. T...
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    RAPS Launches Search for New Executive Director, Announces Interim Management Team

    • 18 February 2016
    The RAPS board of directors announced today that it has initiated a search for its next executive director and that it has selected Russell Reynolds Associates (RRA), a global leader in assessment, recruitment and succession planning, as its partner in identifying a new leader. RAPS, which is the world’s largest organization serving professionals involved in the regulation of medical products, this year celebrates its 40th anniversary in providing leading educatio...
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    RAPS Announces Retirement of Executive Director

    • 11 December 2015
    RAPS announced today the retirement of its Executive Director Sherry Keramidas whose leadership during a 20-year tenure helped advance the healthcare regulatory profession. She will retire on 31 January 2016. “Sherry has served RAPS and its members during a critical period of change in the healthcare industry,” according to RAPS Chairman of the Board Rainer Voelksen. “Her constancy throughout ensured RAPS’ mission to provide leading education and professional deve...