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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 13 August 2014 | By Alexander Gaffney, RAC,
It can be profoundly difficult to monitor—let alone make sense of—the regulatory affairs environment. Thanks to constantly changing laws, regulations, policies, legal developments, technologies and sources of information, regulatory professionals need all the help they can get to conduct regulatory surveillance.
Luckily, even for regulatory professionals without a budget, there are several free tools and websites that can help you find information, stay ahead of your peers and keep track of important information.
RSS feeds are among the most important tools in a regulatory intelligence professional's tool chest. Instead of manually going to hundreds of websites each day, RSS feeds allow someone to subscribe to a website, which will then send plain-text updates to the user's RSS reader every time new content is posted.
For more on using RSS as a regulatory intelligence tool, please read our August 2014 article on the RSS feeds regulatory professionals should follow.
But which RSS reader should professionals use? Here at Focus, our favorite is Feedly, a free-to-use service (with subscription options) that offers a range of options that should be attractive for regulatory professionals.
To begin with, Feedly makes it easy to organize your RSS feeds. With a little bit of time, you can organize websites into different categories, allowing you to quickly conduct information triage and find what matters most. You can also mark feeds as "must reads" to ensure you never miss important information.
The service also maintains full-service mobile phone applications, allowing busy professionals to keep up with their information while on the road or out of the office. Do you prefer to scan the headlines before you get out of bed in the morning? Now you can. A simple option to save articles to read later makes it easy to review content at the office.
Additionally, a new web tool allows Feedly users to save articles they find across the web to their Feedly accounts, eliminating the need to email articles to yourself for future reading.
If you're looking for what's new on the web, Social Mention is a service you can't afford to live without. By using advanced searches, it's easy—and free—to set up alerts for specific keywords no matter where they live on the Internet.
Social Mention searches through blogs, microblogs like Twitter, images, videos and reputable news sites so users can see all the buzz about a particular topic.
Use it to set up alerts about FDA, specific regulators, regulatory keywords, your company, your competitors and the names of your company's products. And yes: You can even set up RSS feeds so that you can follow developments in Feedly.
One word of warning: Be specific in how you set up the alerts in the advanced search toolbar. Broad searches can return a barrage of results that can quickly pile up, hiding valuable content underneath a sea of useless information.
While Social Mention may be good for finding news, the Sunshine Foundation's legislative, regulatory and legislative monitoring tool SCOUT is second to none at finding the government information that matters most to regulatory professionals.
This tool scours federal and state legislative data, court cases and regulatory information based on keywords input by a user. While the information can sometimes be a few days late, it’s more often than not the first place you'll see any mention of new state-level legislation, such as new restrictions on opioids or biosimilar prescribing.
It's also quite useful for tracking federal regulations, especially if you don't have time to read through EPA, DEA, FCC, HHS or other regulatory filings that may still contain information relevant to your product line.
SCOUT also supports RSS feeds.
Let's say you already have a plethora of information sources, but your biggest challenge is making sense of that data. What can you do to keep organized?
One word: Evernote. The free service (which has premium upgrade options) allows you to save articles, documents, notes and files, all with a seamless and easy-to-use organizational structure that allows you to keep track of everything that matters.
Thanks to its mobile app and browser add-ons, you'll easily be able to capture everything that matters to you throughout the day.
Use it to keep track of important legal cases, new regulatory filings, all the guidance documents released by FDA, or background explanations of important regulations that your new co-workers need to know.
If you've ever struggled to find an important article that you read online several months ago, this is one service you can't go without.
Like SCOUT, Court Listener is good for monitoring legal cases, but does so much more thoroughly than does SCOUT, and with more in-depth search options that make it perfect for professionals looking for relevant legal cases or just trying to keep up on development affecting their competitors' products.
While the service doesn't offer custom RSS feeds, it does offer custom email alerts, and also offers its bulk data up to those who want to use it for free.
We know, we know—obvious, right? But the Federal Government's regulatory publishing service, the Federal Register, has a lot of interesting features that new regulatory professionals might not know about.
Take, for example, the Federal Register's " Public Inspection" desk, where FDA and other agencies publish regulatory documents at least (and sometimes more than) a day in advance. Give yourself the edge in your organization and be the first to know about new regulatory developments before your coworkers start asking you questions or, worse, start spreading incorrect information.
Here, you can also subscribe to RSS feeds for FDA notices, subscribe to an email for FDA's (and other agencies') public inspection notices, and search through recent regulations and regulatory filings.
Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in harnessing the power of Twitter for regulatory intelligence.
The platform makes it easier to see a stream of information which updates automatically, allowing users to keep an eye on the latest information, updates and search terms in a single window.
One of the most important parts of regulatory policy is keeping up with what regulators plan to do. And if you're looking to stay current on their thoughts, one of the best free tools can be found at PubMed, the National Library of Medicines' publication database.
Thanks to an excellent set of search filters, you can stay up-to-date on all publications written by select regulators, a particular office of FDA or even everyone working for FDA.
Or, if you're more interested in keeping tabs on your company and its competitors, you can instead keep tabs on certain drug names and other regulators topics. The choice is yours.
While PubMed supports RSS feeds, many of the articles it links to are—unfortunately—behind their respective journals' paywalls.
With more than 100 million monthly visitors, Reddit is one of the Internet's most active sites, and certainly one of its most diverse. As Regulatory Focus explained last year, it's an excellent tool to stay current on developments in various disease groups, as many maintain active discussion groups around their particular conditions and trials they are participating in.
Other benefits include staying current on how people might abuse a product, as there are sub-forums dedicated to the misuse of drugs. Regardless of the information you want to find, Meta Reddit Monitor is an indispensable tool for keeping track of hard-to-find information on the site.
And yes, it supports RSS feeds. Just be warned that as a general interest website, you're likely to sift through a lot of garbage before you find any gold.
Looking for More Information? These tools are just the tip of the regulatory intelligence iceberg. For professionals who are looking to learn more about the field, Regulatory Intelligence 101, a new book by Meredith Brown-Tuttle, RAC, is a great starting point for learning about the field of regulatory intelligence.
Find out how regulatory intelligence can benefit organizations large and small, other free and subscription tools professionals can use to save time and money, advice on how to structure regulatory intelligence operations within a company, and tips and tricks on how professionals can do their job better. The book can be ordered online here.
Tags: Information, Intelligence, Regulatory, Surveillance
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