• RAPS' LatestRAPS' Latest

    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
  • RAPS' LatestRAPS' Latest

    Risk Management: What Regulatory Professionals Need to Know

    For companies looking to develop new therapies or improve existing ones, and for the regulators overseeing them, striking right balance between potential benefits to patients and an appropriate level of risk is critical. The drive to innovate, develop new and better products, and help patients live healthier lives has led to numerous medical breakthroughs. But it is just as imperative that products are as safe as possible, and that where there are associated risks, they a...
  • RAPS' LatestRAPS' Latest

    Top Latin American Officials to Examine Region’s Regulatory Challenges and Opportunities at RAPS Regulatory Convergence

    RAPS’ upcoming 2018 Regulatory Convergence , to be held 1–4 October in Vancouver, will once again serve as the venue for a high-level discussion of the regulatory challenges and opportunities for introducing innovative medical treatments throughout Latin America. Some of the region’s top regulators, such as Rafael Pérez Cristiá, MD, PhD, director of the Center for State Control of Drugs and Medical Devices (CECMED), part of Cuba’s Ministry of Public Health; and Julio Sán...
  • RAPS' LatestRAPS' Latest

    How to Prepare for the RAC Exam

    Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the only professional credential specifically for regulatory professionals in the healthcare product sector. It shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but also that you are committed to your profession. To get the credential, you must pass one of four challenging RAC exams—the average pa...
  • RAPS' LatestRAPS' Latest

    231 Earned Regulatory Affairs Certification (RAC) in Spring 2018

    RAPS announced today that 231 regulatory professionals passed Regulatory Affairs Certification (RAC) exams during the most recent testing period, which took place during April and May of this year, thereby earning the RAC credential. The RAC is the only professional credential specifically for regulatory professionals in the healthcare product sector. To earn and keep the credential, one must first pass one or more of the four exams —US, EU, Canada or Global—and then ...
  • RAPS' LatestRAPS' Latest

    RAPS and CAPRA Collaborate on Authoritative Book on Canada’s Medical Device Regulations

    While Canada’s medical device market may be small compared with that of the US or EU, it ranks among the top 10 in the world. The Canadian government estimates the country’s device market to be worth $6.7 billion (US) and about 2% of the global market. The US Department of Commerce’s International Trade Administration values it even higher at an estimated $8 billion , making it the world’s ninth largest. A new book, Fundamentals of Canadian Medical Device Regulation...
  • RAPS' LatestRAPS' Latest

    Focus on: Cary Coglianese (Part 2 of 2)

    Cary Coglianese is the Edward B. Shils Professor of Law and the director of the Penn Program on Regulation at the University of Pennsylvania Law School. He specializes in the study of regulation and regulatory processes, with an emphasis on the empirical evaluation of alternative regulatory strategies and the role of public participation, negotiation and business-government relations in policy making. He has written extensively on the topic of regulation, including many...
  • RAPS' LatestRAPS' Latest

    Focus on: Cary Coglianese (Part 1 of 2)

    Cary Coglianese is the Edward B. Shils Professor of Law and the director of the Penn Program on Regulation at the University of Pennsylvania Law School. He specializes in the study of regulation and regulatory processes, with an emphasis on the empirical evaluation of alternative regulatory strategies and the role of public participation, negotiation and business-government relations in policy making. He has written extensively on the topic of regulation, including many...
  • RAPS' LatestRAPS' Latest

    Focus on: Daniela Drago

    It seems Daniela Drago has seen the regulatory profession from nearly every angle. She currently heads up the regulatory affairs program at The George Washington University’s School of Medicine and Health Sciences, in Washington, DC. Before entering academia, she spent two decades in various corporate regulatory affairs positions for both pharmaceutical and medical device companies. She has worked internationally and is recognized as an expert on global regulatory affairs...
  • RAPS' LatestRAPS' Latest

    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...
  • RAPS' LatestRAPS' Latest

    8 Networking Tips for Regulatory Convergence Attendees

    The 2018 RAPS Regulatory Convergence at the Vancouver Convention Centre in Vancouver, BC, 1–4 October, will offer attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. At the Convergence, you will be surrounded by people who truly ‘get it.’ They understand regulatory issues, and have gathered together to examine them in depth, share ideas and meet other like-minded pr...
  • RAPS' LatestRAPS' Latest

    RAPS, CAPRA Collaborate to Bring Canadian Regulators and Expertise to Global Audience

    Health Canada Officials will speak at the 2018 RAPS Regulatory Convergence in October, providing updates on the Canadian government’s latest efforts to improve public health by promoting better access to therapeutic products. The Convergence is the world’s largest annual gathering of healthcare product regulatory professionals and RAPS' signature annual event. The session featuring the Canadian regulators is being produced by the Canadian Association of Professionals i...