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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...
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    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...
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    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...
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    Regulatory NewsRegulatory News

    Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial Sandoz Files Humira Biosimilar for US Approval (16 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Room for another: Sandoz files Humira biosimilar in US ( BioPharmaReporter ) ( PMLive ) ( Press ) Eiger to abandon blood pressure drug after trial failure ( Reuters ) ( Endpoints ) ( Press ) Big Pharma efforts on Alzheimer's tested by Pfizer exit ( Financial Times ) Transparency: FDA to Release Portions of Redacted Clinical Study Reports ( Focus ) ( STAT ) Op ...
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    Regulatory NewsRegulatory News

    Regulatory Recon: Google Backs UK Universal Vaccine Company Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Gene Therapy Could Make Cancer Care More Unequal, and This Map Shows Why ( MIT Technology Review ) States require doctors to use prescription drug monitoring systems for patients ( Washington Post ) FDA Delays Implementing Parts of 'Intended Use' Rule ( Focus ) ( STAT ) ( Pink Sheet -$) ( Law360 -$) Billionaire-owned Hearing Aid Manufacturer's Former Executives...
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    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer ( Endpoints ) ( Reuters ) ( GenomeWeb ) ( FDA ) Trump expects medical exam to go well Friday ( Reuters ) Drugmakers see a pricing blueprint in an $850,000 gene therapy ( Reuters ) Wait, It Costs How Much? Biotech Balances Optimism, Uncertainty For 2018 ( Forbes ) Gene therap...
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    European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States. That marks a change in the policy Swissmedic established whe...