Bloomberg reports." />
Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 16 July 2015 | By Michael Mezher
Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports.
Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS).
Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. Adverse event reporting is critical to ensuring a product's safety after it is approved, as clinical trials sometimes fail to identify potentially dangerous side effects.
Recently, FDA has been looking into alternative means of gathering adverse event information, including through the use of social media and data mining literature reports to predict drug effects, though the latter proposal was abandoned.
In July 2014, Focus reported on a letter published in Clinical Pharmacology & Therapeutics, in which two FDA researchers argued that search engine logs could be used to identify adverse events.
The authors of the letter argued that drug safety "hypotheses generated by the use of Internet search logs could be viewed as yet another data source" for identifying adverse events. However, the authors also found it difficult to determine the significance or cause of an adverse event signal in this manner. The authors concluded that, if FDA is to use data from search engines to identify adverse events, the agency must determine how to filter the information into something usable.
According to Bloomberg, an FDA representative confirmed the meeting with Google, and said it was an opportunity "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google's technologies and data."
While FDA and Google declined to comment further to Bloomberg, one of Google's representatives on the call was Evgeniy Gabrilovich, who in 2013 wrote a paper describing methods of finding adverse events through search queries. The study looked at 176 million Yahoo searches from 2010, and found that their methods could be "advantageous in identifying previously unknown adverse drug reactions [that] should be considered as candidates for further scrutiny by medical regulatory authorities."
While it is uncertain whether this meeting will yield any initiatives on the part of FDA, it is clear that the agency is still interested in using the Internet and social media in its drug-safety surveillance operations.
Bloomberg, FDA Public Calendar
Tags: Google, pharmacovigilance, adverse events, side effects
Regulatory Focus newsletters
All the biggest regulatory news and happenings.