Faneca Porter is an ambassador with Baltimore’s Waterfront Partnership. She has an affable smile and cheerful disposition. It’s easy to catch her enthusiasm for all that Baltimore—and in particular, the city’s vibrant inner harbor—has to offer as she describes the multiple attractions within easy walking distance. The Waterfront Partnership offers maps, directions and guidance to visitors to help them make the most of their time in Charm City. “People love to...

If you will be attending RAPS’ upcoming Regulatory Convergence , 24–28 October in Baltimore, it’s time to let you in on a little secret that may not stay secret much longer. Baltimore is quickly becoming one of the East Coast’s premier cities for great food. With its working class roots and reputation for crabs and Old Bay seasoning, but little else food-wise, the city has not traditionally been thought of as a dining destination. That all started to change se...

With RAPS’ Regulatory Convergence coming to Baltimore, 24–28 October, the signature annual event for the regulatory profession will not only be held within close proximity to the US Food and Drug Administration’s (FDA) Maryland headquarters, it also will return to the home turf of one of RAPS’ most active and enthusiastic chapters. Several local members of the RAPS DC/Baltimore Chapter gathered at Baltimore’s inner harbor recently to record a short welcome ...

Best-selling author, TV host, behavior expert and Regulatory Convergence keynote speaker Daniel Pink has spent years looking at why people do the things they do, and how sometimes subtle changes can make big differences in their behaviors. As host of The National Geographic Channel’s Crowd Control , he has conducted fascinating experiments that show just how some of these changes play out in real-world situations, and how social science can be used to tackle r...

As the calendar has turned from August to September, all of us at RAPS headquarters are counting down to RAPS’ Regulatory Convergence , which is now just a few short weeks away. I look forward to welcoming you to the Convergence, 24–28 October in Baltimore. The Convergence is all About Regulatory The Convergence is 100% for and about the regulatory profession. It is about much more than just skimming the surface on regulatory issues. The dynamic educational sess...

If you look at the conference agenda for RAPS’ Regulatory Convergence taking place next month, you might notice some recurring themes. The importance of regulatory strategy, the intersection of regulatory and business and the need to build regulatory capacity and competence will be discussed and thoroughly examined during the Convergence. With more than 100 sessions and more than 300 speakers, the Convergence promises to cover a wide range of re...

One of the many highlights of RAPS’ annual Regulatory Convergence is the opening keynote speaker. The opening presentation often sets the tone for the entire conference and gets attendees talking and thinking in new ways right from the start, and this year’s keynote on 26 October in Baltimore from author and TV host Daniel Pink promises to be a memorable one. Pink is known for using “diabolical psychology for the greater good,” as he likes to say. He delves into...

Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff , MD, will speak to attendees of the 2015 RAPS Regulatory Convergence . RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore. Ostroff will speak 27 October, delivering a special keynote address, then he will participate in a panel discussion on key agency activities and initiatives. Other expert panelists are expected to be announced in...

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...

New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients. The standard, S10 – Photosafety Evaluation of Pharmaceuticals , was developed by the International Conference on Harmonisation (ICH), an international body composed of FDA, the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Device Agency (PMD...

The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...

When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...