RAPS’ Regulatory Convergence is the world’s largest annual gathering for the healthcare product regulatory profession, and this year will be held 17–20 September in San Jose, CA. Speakers and attendees come from all over the world to learn, network and exchange ideas. We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Convergence, and here’s what they had to say: “Regulatory Convergence is...

The Regulatory Convergence will return to San Jose, CA, in 2016, bringing RAPS’ signature annual event back not only to one of the world’s premier centers of technology and innovation—Silicon Valley—but also to the home of RAPS’ oldest and one of its most active chapters, the San Francisco Bay Area Chapter. RAPS asked some of the local chapter’s volunteers and other local regulatory professionals about what makes the San Francisco Bay Area such a special place, an...

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves Allergan's combination therapy for hypertension ( Reuters ) ( PR ) Teva Painkiller Resists Snorting, Injection Abuse, FDA Staff Say ( Bloomberg ) Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA ( PR ) ( Reuters ) Supreme Court rejects GSK bid to throw out racketeering lawsuits ( R...

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling. Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data , seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials. According to ICH, the guideline "will clarify points to consider ...

R “Ray” Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS’ 2016 Regulatory Convergence conference in San Jose, CA. The Convergence, the largest annual gathering of healthcare product regulatory professionals, will be held at the San Jose Convention Center 17–20 September. Wang works with Global 2000 companies on areas including innovation, busines...

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...

The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA). The 15 categories of guidance documents planned for 2016 range from advertising (including a potentially controv...

With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can not only negotiate three new user fee agreements but fill an enormous number of staff vacancies. CDER Director Janet Woodcock, speaking Monday at the FDA/CMS Summit in Washington, DC, outlined 2015’s achievements and a number of the agency’s top priorities for ...

Starting today, you will be able to download the new RAPS Events mobile app for Apple and Android devices. The app has been customized for the 2015 Regulatory Convergence conference, taking place 24–28 October in Baltimore, where attendees will get the first chance to try it out. Convergence attendees will be able to use the app on mobile devices to find information about Convergence sessions, speakers, events and activities; share their own photos and comments...

RAPS’ annual Regulatory Convergence is now less than three weeks away. The event, taking place this year 24–28 October in Baltimore, is the largest annual gathering of the global healthcare regulatory community, including healthcare product regulators, scientists, innovators, and regulatory professionals from life sciences companies of all sizes. This year’s conference will feature keynote remarks from Acting Commissioner of the US Food and Drug Administration (FD...

Baltimore understands if you’re unaware of many of its charms. With Washington, DC less than an hour south and Philadelphia two hours to the north, Baltimore is used to being overshadowed and underrated. But the truth is that the town that calls itself Charm City lives up to that moniker, and it offers a wide range of things to see and do. If you are coming to Baltimore for RAPS’ 2015 Regulatory Convergence , don’t miss the chance to experience some of...