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    Experts to provide insight on FDA under Biden during RAPS virtual event

    As the COVID-19 pandemic continues, and the virus’s highly transmissible delta variant fuels a spike in new cases, hospitalizations and deaths, the work of the US Food and Drug Administration (FDA) has arguably never been more critical. The agency made big news again this week as it took the highly anticipated step of granting full approval to the Pfizer-BioNTech coronavirus vaccine. Beyond the front-page headlines, what are the other important developments at FDA reg...
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    RAPS’ new International Fundamentals book includes pandemic-related updates, and a lot more

    There is no question the COVID-19 pandemic has stressed healthcare systems around the world, forced manufacturers and regulators alike to rapidly shift both priorities and processes, and created a broad range of new challenges. It remains to be seen what long-term changes will result from the crisis, but regulatory professionals are already dealing with some of the effects. RAPS’ recently released Fundamentals of International Regulatory Affairs, Fifth Edition , was ...
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    122 earn RAC in spring 2021 exam period

    RAPS today announced the names of the 122 professionals who earned Regulatory Affairs Certification (RAC) in the most recent RAC exam period this past spring. The RAC is the leading credential for regulatory professionals in the healthcare product sector. “Congratulations to all who passed the RAC exams! It is a great accomplishment,” said RAPS Interim Executive Director Bill McMoil. “Earning the RAC demonstrates not only regulatory knowledge and critical thinking ski...
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    FDA’s Marks and Shuren to speak at RAPS Convergence opening

    RAPS today announced that two of the US Food and Drug Administration’s (FDA) top officials will appear on a panel during the opening plenary kicking off RAPS Convergence 2021 . Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research (CBER), and Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), will join a discussion on COVID-19, regulatory affairs, and the impact on patients, on 12 September—the first...
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    Author offers advice for navigating combination products approval pathways

    With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products , by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a significant need for practical guidance on navigating the regulatory pathways for products combining multiple technologies. Prior to writing the book, “there was no place that I found that I could look to find all of the information I was interested in on different topics t...
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    RAPS announces board slate; Cooper, Salditt to serve second terms

    The RAPS nominating committee has selected the slate of new members set to join the board for the term beginning 1 January 2022, following careful review of all nominations for two open director positions. Following are the two incoming directors: Carol Cooper , MS, RAC, IM(ASCP), RM(AAM), principal, CM Cooper and Associates Diana Salditt , FRAPS, independent regulatory advisor, (formerly) senior program director, Medtronic  Both Cooper and Salditt are current fi...
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    RAPS Euro Convergence draws participants from 32 countries to hear from European regulatory experts

    RAPS Euro Convergence 2021 , the premier annual event for European regulatory professionals, wrapped up today after three days of online education sessions, expert presentations and panel discussions, and web-based professional networking opportunities.   Held virtually for the second year, the event drew 370 registrants from six continents and 32 countries. Over the course of 65 sessions, attendees heard from—and had the chance to connect with—168 expert speakers fro...
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    RAPS Euro Convergence: A preview

    RAPS Euro Convergence is just around the corner. The three-day conference devoted to European healthcare product regulations and regulatory issues kicks off Monday 10 May, running through 12 May. Pre-conference workshops begin Friday, 7 May.   This year’s all-virtual program will feature more than 130 expert speakers and more than 40 educational sessions. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA),...
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    Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity

    RAPS recently brought together three leading authors of the just-released, newly revised third edition of Regulatory Intelligence 101 to discuss the book and the practice of regulatory intelligence (RI). Author and global RI expert, Céline Rodier Seguy, joined lead editors, Daanish Ashraf and Bill Sietsema to answer questions and provide insight on keeping up with complex and constantly changing regulatory information, during a live webcast moderated by RAPS Senior Edi...
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    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 leading credential 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 two challenging RAC exams. The average pass rate is between 40% ...
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    138 Global Professionals Earn Regulatory Affairs Certification (RAC) in Autumn 2020

    RAPS announced today the names of 138 individuals who passed Regulatory Affairs Certification (RAC) exams last autumn. By passing the rigorous exam, they earn the RAC, the leading credential for regulatory professionals in the healthcare product sector. The RAC exams test knowledge of regulations governing pharmaceutical products or medical devices, depending on which version of the exam—RAC Drugs or RAC Devices—is taken, as well as how the regulations are applied in ...
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    Is Regulatory Affairs Certification right for you?

    If you are a considering pursuing Regulatory Affairs Certification (RAC) , you may be wondering what the return on investment will be, or whether you are ready to take one of the challenging RAC exams? The answers to these questions depend largely on you. Before you decide, you should consider things like the amount of regulatory experience you have, potential additional credibility to be gained, the level of support you have from your employer and how much time you c...