Jenni Pickett

Getting free-text #MSL insights is tricky. If the #MSLs input doesn't contain the right components, they become hard to analyze. The person analyzing the insights will have no idea what to do with them. This can negatively impact the value of the insight and the MSL. A great trick to writing impactful insights that help drive decision-making is to 💥think about the person reading them💥 Remember, they weren't in the meeting with you and will need the appropriate context. If you or your team are struggling with writing free-text insights, check out the MSL Insights Course: mslgrowth.com We provide a framework to help MSLs write insights that help shape strategy. #medicalexcellence #medicalaffairs

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Dear All, US FDA is hosting a workshop on Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration. It is free to attend virtually. Please find the more details below. Title: Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration Date and Time: March 27, 8:30 am – 5:30 pm, March 28, 8:30 am – 5:30 pm Co-hosts: FDA and the Center for Research on Complex Generics (CRCG) Location: In-person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop Registration Link: https://lnkd.in/gXfZzHUP Click on Get Ticket and fill in the details. The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products when utilizing efficient characterization-based bioequivalence approaches. The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs. The focus will be on IVPT method procedures that abbreviated new drug application (ANDA) applicants frequently struggle to implement successfully, and the procedures will be demonstrated using different IVPT diffusion cell systems from major manufacturers. Critical considerations to guide investigators during method development, validation, and study conduct will be discussed at each stage. Also, best practices for dealing with issues that arise in different scenarios will be discussed. Workshop Topics • Theoretical/conceptual understanding of the recommendations in the IVPT guidance • Demonstration of step-by-step procedures using 4 different diffusion cell systems • Critical considerations for method development, validation, and study conduct • Expert guidance and best practices for overcoming challenges. Registration Fees: • This workshop is FREE for virtual attendees. Introduction to the Workshop DAY 1 Session 1: Current status and challenges with IVPT studies Session 2: How to develop an IVPT method – Theoretical understanding and hands-on demonstrations Session 3: In-Person activities DAY 2 Session 1: Considerations related to the analysis of IVPT data Session 2: Holistic Panel Discussion Session 3: In-Person Activities (Continued from Day 1) #Topical #IVPT #FDA # FDAGuidance #FDAWorkshop

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New FDA Guidance Released! On September 16, 2024, the FDA introduced the final Study Data Technical Conformance Guide, offering a comprehensive framework for submitting study data. Here’s a quick overview of what’s covered: 1. Introduction: Outlines regulatory policies, the guide’s purpose, and document control. 2. Planning and Providing Standardized Study Data: Offers recommendations for developing a study data standardization plan and creating reviewer’s guides for both study and analysis data. 3. Exchange Format: Electronic Submissions: Details the specifications and recommendations for file formats supported by the FDA. 4. Study Data Submission Format: Provides guidance on using standards such as SDTM, ADaM, and SEND for clinical and nonclinical data submissions. 5. Therapeutic Area Topics: Includes specific recommendations for data submissions related to therapeutic area extensions of FDA-supported standards. 6. Terminology: Advises on the use of controlled terminologies and vocabularies for clinical and nonclinical data. 7. Electronic Submission Format: Specifies how to submit study data using the electronic Common Technical Document (eCTD) format. 8. Study Data Validation and Traceability: Offers recommendations on data conformance, validation rules, traceability, and legacy data conversion. Dive into the full guide here: https://lnkd.in/gUgwirab Stay informed and ensure your study data submissions meet the latest FDA standards! #USFDA #StudyData #ClinicalTrials #DataStandards #RegulatoryAffairs #Pharma #Biotech #Innovation #CDER #CBER

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📌 Pin this post - Two months ago I shared the list of #FDA Guidance documents on #NAMS; today I'm sharing the product centers and their approach to NAMs #qualification. See comments for link to the list of guidance documents. These resources were taken from the FDA Science Board Report on New Approach Methodologies, presented to FDA on 7-Oct-2024; it includes their recommendations to FDA on how to foster adoption and utilization of NAMs in the regulatory context. Link to the report is also in the comments. Could be useful for those developing their applications to the The National Institutes of Health #ComplementARIE program. #CBER #CDER #CDRH #CFSAN #CTP #CVM #HFP (#CFSAN)

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FDA has released their guidance for AI-Device Software Functions. Here are a few of my thoughts based on the guidance and the 3 PCCPs I have helped achieve authorization. 1- Alignment on terms. I appreciate that FDA has defined the terms for the data sets. You have Training, Tuning and Test data. This may seem like a small item but this alignment on terms would have been of benefit to the first PCCP I submitted. 2- Additional clarification that a PCCP must be reviewed as part of a Pre-market Submission. I have been approached by numerous people over the last year that did not fully understand that to establish a PCCP it must be part of a submission. 3- Your PCCP needs to be a stand-alone section of your submission. It should be as comprehensive and self-contained as possible. 4- Labeling. Don't forget to include draft labeling of how you will communicate to your device users that a PCCP is authorized for your device and include information on how it will impact their use of the device. I.e. automatic updates, manual updates or anticipated variations in device performance. 5- Your PCCP is a static document. Once it is authorized it is locked, changes to PCCP will require a new pre-market submission. 6- Describe your modifications. FDA needs you to describe the modifications you want to make, why they are appropriate under a PCCP and how they would be deployed (I.e. Automatically or through a manual process). 7- Modification Protocol. Describe how you are going to test your changes and ensure they still meet the verification and validation requirements. This should include predefined acceptance criteria. Be specific, you need to communicate the threshold of improvement that you would implement. 8- Impact Assessment - How will you assure that the modifications may impact the overall device. Compare the modified with cleared device and discuss an impact to the risk/benefit analysis of your device. Describe how you still meet the safety and efficacy of your device. This is just a high overview. I think this guidance helps clarify the PCCP requirements and is in alignment with the elements that we put together while working through the PCCP process on the projects I supported. If you need help with your PCCP for an AI-DSF feel free to reach out. I am also still available and seeking roles in the SaMD, AI/ML and Digital Health Med Tech space. Let me know if I can help your team. https://lnkd.in/gKUnEDbF #SAMD #PCCP #Medtech #AI/ML #RegualtoryAffairs #DigitalHealth

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Navigating New FDA Draft Guidance on REMS Published by: #FDA in #USA on 09-May-2024 The FDA’s recent draft guidance introduces an updated REMS logic model, offering a structured framework for drug safety evaluation. Key takeaways include: 1️⃣ Systematic REMS Framework: Guidance on designing, implementing, and evaluating REMS for better alignment with health outcomes. 2️⃣ Flexibility in Compliance: Allows alternative approaches that meet regulatory requirements, enhancing adaptability. 3️⃣ Mandatory Evaluations: Stresses on regular REMS assessments to maintain efficacy and adapt to new information. 4️⃣ Specialized Requirements for Providers: Some drugs may require healthcare providers to have specific training or certifications based on the drug’s risk profile. This draft represents the FDA’s ongoing efforts to refine drug safety measures through effective risk management strategies. Source: https://lnkd.in/gHUV7WuT #pharma #pharmout #REMS #FDA PharmOut What is REMS? The FDA's REMS program ensures the balance of medication benefits over risks by implementing tailored strategies. Required for medications with serious safety concerns, REMS involve stakeholders like healthcare professionals, patients, and manufacturers. The FDA determines, specifies, and approves REMS, while manufacturers develop and implement them, encompassing risk mitigation goals, communication plans, and necessary activities. Source: https://lnkd.in/g3PEWzrU

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🎢 CAPA Requests: Turning Compliance Into a Breeze! 🎢 Hey LinkedIn fam! Ever felt like CAPA requests are a maze with no end? Well, fret not! My new slide deck, "How I Mastered Responding to CAPA Requests," is here to save the day. Here’s what you’ll find: Receiving CAPA Requests: First step – don't panic! Review the docs like a pro. CAPA Templates: Because who wants to reinvent the wheel? Crafting Your Response: Root causes, corrective actions, and preventive actions – the triple threat! Example Structures: Copy-paste-worthy examples to make life easier. Submission Formats: Digital all the way – keep it eco-friendly, folks! Evidence and Timelines: How to show you’re not just talk and when to ask for more time without sounding like a slacker. Let’s transform those CAPA blues into a dance of compliance and efficiency. Happy responding! 🕺💼 #CAPA #Compliance #Efficiency #ProfessionalDevelopment #ProcessImprovement

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ISO 42001: A Framework for Responsible AI Adoption As AI rapidly transforms industries, ISO 42001 emerges as a standard for establishing robust AI governance. This framework, I believe will become crucial for organisations across healthcare and pharmaceutical sectors to ensure ethical, transparent, and accountable AI implementation. "How do you use AI in your organisation to get the 'Job' done?" Key benefits: > Mitigates AI risks: Identifies and addresses biases, errors, and unintended consequences. > Promotes ethical AI: Ensures transparency, fairness, and accountability. > Builds trust: Fosters confidence among stakeholders and the public. > Ensures compliance: Aligns with legal requirements and industry best practices. Challenges: > Evolving landscape: Requires continuous adaptation to keep pace with AI advancements. > Implementation: Demands expertise and resources for effective AI management. > Limited scope: Focuses primarily on technical aspects, not broader societal implications. > It is new! A full slide deck will be available to participants who attended the #PharmaDeviceForum in #melbourne on 23-24th May 2024. #QualityManagement #HealthcareExcellence #pharma #pharmaceutical #Governance PharmOut

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Tackling Data Integrity Challenges in GLP Studies 🔍 Data Integrity in Focus: Are Your GLP Studies Ready for Regulatory Scrutiny? Data integrity has become a hot topic in nonclinical research, with regulatory bodies like the FDA and OECD increasingly scrutinizing how laboratories handle their data. In recent inspections, common observations have included: 1️⃣ Incomplete Audit Trails: Failing to track changes in electronic data, especially in critical areas like toxicology and pharmacokinetics. 2️⃣ Inadequate Data Backup: Facilities not maintaining proper data backup systems or failing to ensure that backups are tamper-proof. 3️⃣ Manual Adjustments Without Documentation: Instances where manual data edits were made without proper justification or documentation. 4️⃣ Gaps in Training: Teams unaware of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete). 5️⃣ Weak Electronic Systems Validation: Issues with software validation in labs, leading to questions about data reliability. Why It Matters Regulatory authorities emphasize that any breach in data integrity can lead to delays, rejections, or even non-approval of nonclinical studies. Ensuring compliance is not just a regulatory requirement but also a commitment to the credibility of your research. Practical Steps to Address These Challenges ✅ Conduct regular internal audits focused on data integrity and system validation. ✅ Train staff on ALCOA+ principles and the latest guidelines for data handling. ✅ Invest in robust data management systems with secure audit trails and backup protocols. ✅ Establish clear SOPs (Standard Operating Procedures) for data recording, review, and archival. ✅ Partner with vendors for electronic systems validation to avoid potential compliance risks. Looking Ahead Data integrity is no longer just about compliance; it’s about building trust with regulators, sponsors, and stakeholders. By proactively addressing these challenges, GLP facilities can ensure smoother submissions and better outcomes in nonclinical research. How Can PPS Help? At Plexus Preclinical Services, we specialize in conducting data integrity audits, developing compliance-focused systems, and providing comprehensive ALCOA+ training. Our team ensures your facility is prepared for any regulatory scrutiny while strengthening your data reliability and trustworthiness. 📞 Contact us to discuss how we can support your journey toward seamless data integrity and GLP compliance! Logo 🌐 Visit: plexuspreclinical.com to know more! 📞 Phone/WhatsApp: +91 9979892613 ✉ Email: [email protected]. #DataIntegrity #GLPCompliance #RegulatorySupport #NonclinicalResearch #ALCOAPrinciples

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🚨 **Attention Industry Professionals!** 🚨 Have you heard about the recent trend where the FDA is advising companies that receive warning letters to engage a Good Manufacturing Practice (GMP) consultant? This is a significant shift that underscores the importance of compliance and quality assurance in our industry. Navigating the complexities of GMP can be daunting, especially when facing scrutiny from regulatory bodies. Companies are realizing that partnering with experienced consultants is not just beneficial but essential for ensuring compliance, improving operational efficiency, and ultimately safeguarding public health. This is where NSF comes into play! 🌟 With our extensive expertise in GMP regulations and hands-on experience across various sectors, NSF is perfectly positioned to help organizations turn challenges into opportunities. Our team of seasoned professionals can provide tailored guidance, conduct thorough assessments, and implement best practices to help you stay ahead of compliance issues. 📈 Investing in a GMP consultant isn't just about reacting to a warning letter; it's about proactively strengthening your quality systems and fostering a culture of continuous improvement. Let's prioritize quality and compliance together! If you or your organization is navigating these waters, consider reaching out to NSF for support. Together, we can build a safer and more compliant future for our industry. #FDA #GMP #QualityAssurance #Compliance #NSFInternational #Pharmaceuticals #Biotechnology #FoodSafety #Consulting #NSF

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Why does data dumping hurt a #medicalscienceliaison? It blocks #relationshipbuilding. How? It impairs an MSL's ability to connect with an HCP/KOL: 1. The HCP/KOL gets bored and loses interest 2. The HCP/KOL may misinterpret the data 3. It wastes precious time with the HCP/KOL 💻Read more on the Medical Affairs Value blog, see if you are guilty of data dumping, and learn a great tip for how to reengage to help prevent you from data dumping. The link is below in the comments! #medicalaffairs #medicalexcellence

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“There's this culture that if you sit with R&D, they hear regulatory and the understanding is you're not creative, you're just a paper pusher and you don't understand innovation, that you're stifling innovation." Regulatory is about more than safety and quality. Regulatory frameworks are often viewed as hurdles, but I've found that they provide clear guidelines and incentives for companies to push technology's boundaries. Hopefully, Hasnaa Fatehi can help you see things my way. I’ve had regulatory and quality folks my whole career. They are part of the team and wo them the best product doesn’t sell wo approval. In medical device is especially takes a team to make this happen https://lnkd.in/gn8ewa3s #Regulatory #MedTech #Innovation

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Two pharma teams. Two regulatory submissions. Two very different outcomes. Team A: Twelve revision cycles, six months delayed, writers and reviewers teetering on the edge of sanity. Team B: One revision. Done. Submitted on schedule. Everyone is delightfully sane. The difference wasn't writing skill. It was something far more fundamental. The conventional wisdom? Add more reviewers. Create more templates. Add more comments. But here's what working with dozens of pharma teams has taught me: Technical documentation fails when we treat it as a product to fix rather than what it really is—evidence of how we think through complex information. Consider: A development report comes in from your research team. The science is solid, but the document needs "major revisions." Traditional approach: Mark it up, send it back, repeat until acceptable. Result: Weeks or months of back-and-forth, frustrated teams, and delayed submissions. But what if that unclear document isn't just poorly written? What if it's revealing gaps in shared understanding about: - What regulators need to see and why - How data should be presented - Which details matter most The teams that consistently produce strong technical documents don't just write better. They align on understanding before anyone opens a document. They approach writing strategically. They use their problem-solving skills to think through who needs what information and why. They plan how to present complex data for maximum impact. And only then start writing. I saw this work brilliantly with a Phase III clinical team. Before writing began, they got clear on: - Exact regulatory requirements - Key data presentation formats - Critical success factors Result? One revision cycle. Then done. Want to transform your team's technical documentation? Stop treating unclear documents as writing problems to fix. Start seeing them as opportunities to leverage the strategic thinking your team already excels at. Your regulatory submissions—and the patients waiting for them—will thank you.

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Sponsors, watch out! 10 pitfalls undermining your clinical audit’s effectiveness. Vague Audit Objectives: Not defining clear, measurable goals for the audit. One-Size-Fits-All Approach: Not tailoring the audit process to the specific study or team. Surface-Level Reviews: Skimming the surface rather than diving deep into processes and outcomes. Ignoring the Big Picture: Focusing on tiny details while missing systemic impact. Negativity Bias: Focusing solely on what’s wrong without recognizing what’s working well. Fear of Transparency: Hiding or glossing over issues instead of addressing them head-on. Ignoring Context: Not considering the operational context of findings. Withholding Feedback: Not providing immediate constructive feedback during the audit.   Overuse of Jargon: Making audit observations hard to understand for the auditee with too much technical language. Complex Reporting: Making it hard to comprehend the implications of the audit findings.        Avoid these traps to ensure your clinical audit program strengthens rather than undermines your research’s integrity and efficacy.     Would you add anything else from your experiences?     #ClinicalAudits #ResearchIntegrity #BestPractices #ContinuousImprovement 

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I am glad to share that an important guidance for AI in drug development has been published. It is great that Office of Clinical Pharmacology has contributed to the preparation of this guidance. The risk-based framework has been adopted in assessing AI generated evidence.

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I've had a busy month, and only just found the time to draft another post. Here is a sample size/power analysis approximation for the Kruskal-Wallis test. This is one that many biostatisticians have struggled with in the past.

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Good to see the growing role of Real-World Evidence (RWE) in regulatory decision-making.

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