Ashton Rowe

TMF Tips for Success Here are some golden nuggets: 1. Regulatory Guru Status: Stay sharp on ICH-GCP, FDA, and EMA guidelines. They’re not just rules; they’re your playbook! 📚 2.Document Lifecycler: Manage those documents like a pro gardener. Plant, nurture, and watch them flourish from draft to archive. 🌱 3.Communication Maestro: Keep everyone in the loop. Clear, concise, and continuous communication is your symphony. 📲 Working in the TMF isn't a Job, but an art form. Share your tips and experiences below! Learn more here: https://lnkd.in/gUMU2-xm * * * #TrialMasterFile #ClinicalResearch #LifeSciences

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Biotech job seekers need someone in their corner. This a snapshot of the last three people I found a new job: VP Quality - not originally selected for interview. QC Director - not originally selected for interview. QA Director - not originally selected for interview. I’ve spoken to so many senior level quality executives in the last year who have applied for a role via LinkedIn and not got a look-in. Many of these people are qualified for the role and would make great candidates, but their application goes into a ‘black-hole’. It’s incredibly competitive right now. If you haven’t got someone in your corner that understands the true value you can bring to an organisation, and can clearly communicate this to a potential hiring manager, your resume/CV might get overlooked. Work with your headhunter/recruiter to be crystal clear on what benefits your experience brings to a specific organisation.

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🤔 Is your lab ready for the next CAP Inspection? Start by joining Andrew Fletcher MD, MBA, CPE, CHCQM, FCAP, Accumen's Medical Director, for a webinar on the most common deficiencies found during CAP Inspections in 2023. Register Here: https://lnkd.in/eU2qjErP Learn how Accumen can prepare your lab for the next CAP Inspection: https://hubs.ly/Q02z50j10

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Have you checked out our Regulatory Affairs Resource Library? If you're pursuing #FDA drug development pathways, these resources provide insight into the various programs and designations to help you identify applicable, advantageous regulatory tracks. https://ow.ly/AzWw50RmznJ

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Attention #pharmacists and #studentpharmacists! Don’t miss our free webinar on the upcoming changes to the influenza vaccine market. Stay ahead of the game so you are better equipped to answer questions from your patients. Learn about trivalent influenza vaccines as the main therapy, FDA and WHO directives, operational challenges, and more. Enroll today!  https://ow.ly/bUUG50SGbsl  

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Unlock the full potential of your pharmaceutical project with our CMC regulatory affairs consultants. From pre-IND to licensure, we craft and adhere to project timelines, monitor resources, tasks, and budget, integrate expert teams for application review, and offer valuable insights at FDA-Sponsor meetings. Dive deeper into our regulatory services: https://bit.ly/3VTJmnB #CMCRegulatory #FDAApproval #PharmaConsulting #DSI

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You might not want to hear this but, if you think you'll apply to the first CRA opportunity just published on Linkedin and you'll get it, you're mistaken. 🔥 ✅ Yes, there's still a shortage of Clinical Research Associates (CRAs) expected to last til 2030 ❌ But no, that doesn't mean you can access a CRA role without any prior exposure or experience 💡So, here's what you should do instead: Once you've decided that you want to become a CRA: ✨ Assess your own experience and skills to understand where you need to develop further ✨ If you lack some experience, try first a supporting role such as Clinical Trial Assistant, in-house CRA, etc. ✨ If what you lack are skills, good news! Invest time and effort in developing those skills yourself. As you develop and expose yourself more and more to the expertise you need as a CRA, give visibility to yourself. Yes, ✨Expand your network and connect with others with your same interests ✨Show your interest by openly speaking about the CRA role ✨ Show your proactivity by openly speaking about your progress and your learnings If you've learned something new, remember to like 👍 or share this post so that others can benefit as well! 📍If you want to become a CRA or develop your skills and expertise as a CRA, join our private community of international CRAs where we learn together through courses, masterclasses, events, and daily discussions. Link to sign up in comments👇

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Understand the recent updates and changes in the FDA 510(k) program. Learn best practices for submitting 510(k) applications in the eSTAR system from Heather S. Rosecrans and Samantha Eakes, MPH. Register for the OCRA Orange County Regulatory Affairs Discussion Group webinar now to secure your spot and empower your #team for success! https://lnkd.in/gQT8QEPz #enterey #lifescienceconsulting #OCRA #regulatoryaffairs #eSTAR #bestpractices #webinars #southerncalifornia

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Post-marketing commitments play a pivotal role in further evaluating the safety and efficacy of approved drugs by requiring additional studies or surveillance beyond initial approval. The FDA has been intensifying its efforts to ensure companies fulfill their post-marketing obligations, signaling a heightened focus on compliance and transparency. This is evidenced by guidances such as the recently released REMS Logic Model which offers a clear framework for effectively and iteratively conducting a REMS assessment, a process that was not previously well defined. Industry should expect to see additional guidance that supports more stringent post-marketing surveillance. CRC is committed to understanding these changes to ensure our clients maintain regulatory compliance throughout their products' lifecycle. #FDA #REMS #RegulatoryCompliance #Biotech #DrugSafety #Innovation #PatientCare #Consulting 

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The groundwork for a successful regulatory submission process starts early in preparation. 📊We asked if you knew the ideal amount of time to allow for the preparation of your NDA before your FDA filing date. The answer? 'At least one year'. Check out the responses👇 #FDA #NDA #MarketingApplications

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We have a new B&W mini-cast episode up on our YouTube! This month's guest is Don Romero from Pharmers Quality Concentrates in New Mexico. In this episode, Don shares how he deals with haters, mistakes he's learned from as a business owner, luck vs hard work, and more. watch the full episode on our YouTube channel. https://lnkd.in/gnhXtfFK

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Hot off the FDA press IND Safety Reports Can Now Be Electronically Submitted FDA recently published a guidance with instructions for electronic submission of investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). FDA is now accepting IND individual case safety reports (ICSRs) submitted electronically via the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal. Starting in April 2026IND safety reports must be submitted via these two methods. https://lnkd.in/eFF4vtB FDA provides two options for electronic submission of ICSRs and ICSR attachments to FAERS: — FAERS database-to-database transmission (“E2B”) submission through the Electronic Submissions Gateway — Submission through the Safety Reporting Portal (SRP) Submitters will need an account with FDA for either option. The guidance includes instructions for creating one. This guidance finalizes the draft guidance for industry issued in October 2019. This new version includes minor revisions to improve clarity.

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Effective Computer System Validation (CSV) plays a crucial role in ensuring the quality of drugs. We pride ourselves on supporting organizations as we work to transform validation services using the 3 Ps…People, Process, and Platform. We can provide global resourcing, support specific projects, or serve as strategic validation partner. If you would like to learn more about our Validation framework and engagement models, then please click here: https://lnkd.in/gAg5g3rz #Validation #eValidation #CSV #AuditReadiness #CSA #RiskBasedAApproach #ValidationasaService #pharmaindustry #drugefficacy #patientsafety 

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"🚨 Quality Over Correction: The FDA's Wake-Up Call in 2024 🚨 In 2024 alone, the FDA has issued a staggering 15 cease decrees, a testament to the urgent need for proactive quality assurance (QA). As professionals, especially from the east coast to all across the US, we're witnessing the pivotal role QA plays - not just as a fix-it tool but as a prevention powerhouse. The decrees are clear indicators that it's time to shift our focus. 🛑✋ 1) Integrating QA from the get-go is critical. Implementing robust quality controls at each production stage can be the difference between a product's success and a costly recall. Real-time monitoring and risk assessments are no longer optional; they're the lynchpins of trust in our industry. 2) Leveraging QA as a continual process, rather than a final checkpoint, transforms our mindset. It's about embedding a culture of excellence within teams. Embrace QA as the heart of operations, not the ambulance at the bottom of the cliff. 3) The statistics don't just urge, they scream for a change. With the right QA practices, not only do we safeguard consumer health, but we also bolster industry credibility and our own bottom lines. It's a win-win that calls for immediate action and commitment. Leaders, it's time we ask ourselves—is our QA proactive or merely reactive? 🤔 Join the movement towards a safer, more reliable future. Share your thoughts below. ⬇️ #QualityAssurance #FDACompliance #ProactiveChange"

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Last call to register for our June 11th Regulatory Interviewing course (virtual)! Whether you're new to interviewing responsibilities or need a refresher, register today. You'll develop your skill sets in conducting an interview, understanding the responsibilities, categories, and strategies needed to become a successful interviewer. The main objectives include: 1) Discuss the Interviewers mindset 2) Interviewing responsibly 3) Categories of interview subjects 4) Communication Strategies 5) Virtual Interviewing. Register at https://lnkd.in/gGNnwQRF CFR CRF

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The #FDA has moved forward with finalizing their proposed #LDT #IVD guidance. Stay tuned for a part 2 update to our recent blog on where the proposed legislation stood mere days before this latest shift! See the comments for a link to part 1 of this series. https://lnkd.in/eysanFET

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🌟 Searching for Your Next Clinical Research Associate Role? Here Are the Top 5 Ways to Find Your Dream Job! 💼 Are you searching for your next CRA role? Whether you're just starting your career in clinical research or looking to take the next step, a successful job search strategy is essential. Here are five ways to search for your dream CRA job: 1.   Online Job Boards: Websites like LinkedIn, Indeed, and Glassdoor are treasure troves of job listings. Use keywords like "Clinical Research Associate" or "CRA" along with your preferred location to narrow your search. 2.   Company Websites: Explore the websites of pharmaceutical companies, contract research organizations (CROs), and research institutions directly. They often post job openings on their career pages. Keep an eye on your target companies for new opportunities. 3.   Networking: Leverage your professional network. Attend industry conferences, join clinical research associations, and connect with fellow CRAs on LinkedIn. Networking can lead to hidden job opportunities and valuable insights. 4.   Recruitment Agencies: Many specialized recruitment agencies focus on clinical research roles. Consider partnering with them to access their expertise and exclusive job openings. 5.   Professional Organizations: Join associations like the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP). These organizations often provide job boards and career resources tailored to CRAs. Remember, finding the perfect CRA job may take time and effort, but with a strategic approach, you can increase your chances of landing the role that aligns with your career goals. Keep your resume updated, customize your cover letter for each application, and stay persistent. Your dream CRA position maybe just a few clicks or connections away! #ClinicalResearch #JobSearch #CareerAdvice #LinkedInTips #Healthcare #Research #ClinicalTrials #CareerDevelopment

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