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  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA Scales Back Medium-Priority Activities as Brexit Bites

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Scales Back Medium-Priority Activities as Brexit Bites   The European Medicines Agency (EMA) has scaled back certain medium-priority activities to offset the effect of Brexit on its capacity. EMA is further pulling back from international collaborations and suspending certain types of meeting until at least 30 June.   EMA triggered the changes by initiating ...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: MHRA Extends EpiPen Expiry Dates to Mitigate Supply Shortages

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   MHRA Extends EpiPen Expiry Dates to Mitigate Supply Shortages   MHRA has allowed Mylan to extend the expiry dates on certain lots of EpiPen to mitigate supply constraints. The organizations think delaying the expiry of nine lots of the adrenaline auto‐injectors by four months will help ensure patients can access the products while Mylan stabilizes supply.   The ...
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    RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

    RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global. The RAC is the only post-academic professional credential for the healthcare product regulatory field....
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    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...
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    10 Ways to Get the Most From RAPS' Regulatory Convergence

    Your time is valuable. We respect and appreciate the time you take to attend the  Regulatory Convergence , and we want you to get as much out of RAPS’ signature annual event as you can. After all, it is an investment in your job, your career and your regulatory knowledge. And for those of you who may be first-time attendees, it can be particularly helpful to have an idea of what to expect. So we have a few tips to help you make the most of your Convergence experience this...
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    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...
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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...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Government Shutdown Looms First PARP Inhibitor Approved in Japan (19 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Showdown Looms as Senate Democrats Prepare to Reject Spending Bill ( WSJ -$) ( Politico ) House passes stopgap bill that would delay medical device tax; Senate Dems vow filibuster ( MassDevice ) ( MedPage Today ) ( Stat ) No One’s Interests Would Be Served by a Shutdown ( Alliance for a Stronger FDA ) The FDA Budget FY 18: Where Does the Money Come From?...
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    Regulatory NewsRegulatory News

    Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US Doctors Plan to Treat Cancer Patients Using CRISPR ( MIT Technology Review ) Gilead's Kite Teams up With Pfizer on a Lymphoma Combo ( Endpoints ) ( Press ) Fed Up With Drug Companies, Hospitals Decide to Start Their Own ( NYTimes ) ( STAT ) How a government shutdown could affect drug safety, flu response, and more ( STAT ) Senate committee advances Azar nom...
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    Regulatory NewsRegulatory News

    Regulatory Recon: Celgene in Talks to Buy Juno Chinese Investors Eye J&J's Diabetes Business (17 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Celgene in discussions to buy Juno Therapeutics ( Financial Times ) ( CNBC ) FDA and Pentagon Forge Breakthrough Designation Agreement ( Focus ) ( Reuters ) ( FDA ) FDA expects IV fluid shortage to improve in coming weeks, months ( Reuters ) ( FDA ) Is Juno worth a $10B-$12B buyout price? Analysts see megabucks deal in the making on reported Celgene talks ( End...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...