Schlafender Hase’s Post

#2 in particular is a great point - add this question to your list when evaluating a potential software vendor!

In regulated industries, time-to-market is crucial, and precision is paramount. 🕒 Embracing automated proofreading software can enhance both speed and accuracy, while streamlining workflows. Discover 8 ways #regulatory professionals can expedite time-to-market and ensure product success. https://lnkd.in/exwRW22Y

Are you ready to unlock peak efficiency and cost-effectiveness in your publishing and regulatory submission processes? G&L’s experts are here to support your end-to-end publishing challenges with tailored solutions for every client. Curious about our publishing excellence? Contact us now or read more here: https://lnkd.in/eG9JvstP #RegulatoryPublishing #RegulatoryAffairs #QualityAssurance #ClinicalDevelopment

Generating an official redline for a protocol amendment is not always easy😰 💣 Updates to the schedule of events table… 💣 Formatting changes… 💣 And, even relatively minor wordsmithing… …Can all make a redline difficult to read 👀 -- ie, unhelpful 👎 to regulators, investigators, and ethics committees who need a clear view of how your protocol has changed. 💡 Sometimes, the best way to serve everyone involved in the study is to manually tweak ✍ the redline to enhance readability. These manual tweaks can be tedious and require careful attention to detail 🔎 but are worth it to ensure the redline fulfills its purpose of displaying important changes from one version to the next👏 Looking for a collaborative partner to streamline and level-up your protocol amendment writing processes❓ 📨 Email us to set up an intro call: info@meaganeldridge.com

The way this European legislative administration tackled a language barrier is pretty inspiring. It had 22 committees, each speaking a different language, and it sounds like a logistical nightmare to manage all those documents. I can only imagine how much time and energy was wasted on translations, conversions, and trying to keep everything organized. It's a perfect example of how complex document processes can really slow things down. What's really interesting is that the organization used document automation from Adlib to solve this problem. As a result, it transformed this messy, chaotic process into a well-oiled machine. By automating everything from document ingestion to formatting and distribution, the legislative administration eliminated a ton of manual work and potential errors. It just goes to show that with the right tools, even the most daunting challenges can be overcome. Have you ever faced a similar challenge in your workplace where document automation could have been the solution? #DocumentAutomation #DigitalTransformation #Technology https://lnkd.in/eT2Dxkmd

A new entry in our ongoing Sector Series - we talk about translations for the highly complex Regulatory sector. Quite timely too, as I am currently in Berlin for the #RAPSEuroConvergence

🌍 Global Audits: Expanding Horizons and Navigating Challenges 🌍 Engaging in global audits offers significant exposure and experience with international clinical trial regulations, while ensuring compliance with domestic standards. 🌐 Although conducting these audits is highly enriching, it presents challenges in keeping pace with diverse local regulations. 📊 🔍 Check out this comprehensive resource from the U.S. Department of Health and Human Services, detailing the links to the regulatory requirements for various countries: https://lnkd.in/drketvRV DM me for your requests for Audits and Training. #GlobalAudits #ClinicalTrials #RegulatoryCompliance #InternationalExposure #ProfessionalGrowth #Clinicaltrials #Clinicalresearch

Hi folks, Really excited to share a project that I've been working on over the past few weeks-- the Office of Information and Regulatory Affairs (OIRA) will be holding two public training sessions on the regulatory rulemaking process, with live interpretation in Spanish, Mandarin Chinese, and ASL! Regulations affect our lives every day, from protecting the water we drink to keeping workers safe on the job. In designing regulations, it's important that agencies hear from the people who will be affected by them. Under Executive Order 12866, OIRA reviews significant regulations. There are a number of ways you can engage during the regulatory process: submitting a public comment when an agency has issued a proposed rule, and asking for a E.O. 12866 virtual meeting with OIRA to voice your views about a regulatory action that is under OIRA review. The first training session will be held on October 2, 2024 from 3 - 3:45 pm Eastern covering participation in E.O. 12866 meetings, and the second training session will be held on October 9, 2024, from 4 - 4:45 pm Eastern on how to write effective public comments. If you are interested, please email publicparticipation@omb.eop.gov for the Zoom registration links. See the Federal Register for more information here: https://lnkd.in/eGn4ZvpR https://lnkd.in/eMJ_uxrY

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