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With our team as your Quality partner, you gain access to a wealth of knowledge and experience that can help you drive success. Experience the difference of a true Quality partner. Reach out to Helen Kargaryani or Jacqui Levine today to learn more.

In the latest episode of The Emerging Biotech Leader podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech sectors, Helen shares how effective risk management can help companies meet complex regulatory requirements. Helen explains that a robust Quality Management System (QMS) maintains quality, while risk assessment helps identify and mitigate risks to that quality. Aligning these practices helps companies maintain compliance and build operational resilience. Key takeaways from the episode: ✅ Risk management should be tailored to your organization’s unique needs and resources. ✅ Early implementation, even at a small scale, is essential for startups and small biotech firms to establish a strong foundation for growth. ✅ Integration across departments fosters a culture of compliance, reducing the chance of regulatory setbacks and costly disruptions. If you are looking to stay ahead of regulatory expectations and safeguard your company, this episode offers valuable insights. Listen to it here: https://lnkd.in/d3E5Gthb Are you involved in biotech and have insights to share? We’d like to hear from you! Send a message to letstalk@ssistrategy.com.

The FDA has issued a draft guidance document to update recommendations on the collection and use of patient preference information (PPI) across the total product life cycle of medical devices. This new guidance aims to: 1️⃣Expand the scope to cover PPI use throughout all stages of device development and post-market surveillance 2️⃣Provide updated methodological recommendations for both qualitative and quantitative PPI studies 3️⃣Clarify how PPI can influence various regulatory decisions 4️⃣Offer guidance on engaging with FDA regarding PPI study plans and results 5️⃣Recommend ways to integrate PPI into device labeling and shared decision-making tools By ensuring patient voices are heard and considered throughout the device life cycle, from early development to post-market surveillance, the medical device market is likely to become more responsive to patient needs and preferences. This patient-focused approach could drive innovation towards addressing unmet medical needs and improving overall quality of life for those who rely on medical devices. More information here: https://lnkd.in/dUZHZfkK #MedicalDevice #patientsfirst #patientfocuseddrugdevelopment

What if a single treatment could replace a lifetime of medical interventions? Advanced therapies aim to do just that, offering potential one-time solutions for complex diseases. These innovative treatments, including gene and cell therapies, work differently from conventional medicines. While promising, they present unique challenges in development, manufacturing, and regulation. Understanding advanced therapies and their complexities provides insight into an important emerging field in healthcare. Learn more by reading our insight https://lnkd.in/e6FvakTy

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new Medicines Pipeline data program, requesting information on planned or potential future submissions from current and potential Marketing Authorisation Holders (MAHs). This initiative aims to improve the agency's service delivery and assessment timelines. Key points for MAHs to consider: 📌Scope: Provide information on expected submissions up to 5 years in advance, 📌Data required: Product details, active ingredients, product types, indications, expected submission dates and routes, and additional MHRA services needed. 📌Submission Process: Download the template spreadsheet from the MHRA website, fill it with available information, and submit. 📌Updates and Flexibility: Expect to provide updates approximately every 6 months. The MHRA acknowledges that plans may change over time. 📌Participation: All current or prospective MAHs are encouraged to participate, regardless of company size and number of projects. The MHRA emphasizes that this initiative will help them efficiently resource teams, ensure consistent timeline delivery, and prepare for potentially transformative technologies. This proactive approach aims to benefit both the industry and patients through more efficient application processing. Click here to learn more https://lnkd.in/e3t-6iyK #MHRA #medicinespipeline #marketingauthorisation

Demystifying the EU HTA Regulation: Your Top Questions Answered! As the new EU HTA regulation approaches, strategic preparation is key. We're here to guide you through the complexities of this significant regulatory change. In this carousel, we've addressed some of the most frequently asked questions about the EU HTA regulation. From basic definitions to process alignments, we've got you covered! But this is just the tip of the iceberg. Want to dive deeper? Join our upcoming webinar: "EU HTA Regulation Insights: Expert Strategies for Success" In this session, we'll explore more advanced strategies and provide expert insights to help you navigate this new regulation successfully. 🗓️ Date: Thursday, 10th October 🕒 Time: 14:00 BST / 15:00 CEST / 09:00 EDT 📍 Platform: Zoom Don't miss this opportunity to gain valuable insights and ask your burning questions! Sign up now: https://lnkd.in/dX2MUtwp #EUHTA #HealthcareRegulation #BiotechInnovation #BuildingBetterBiotechs

🔍Inspection Readiness: Are You Prepared? Regulatory inspections are a critical milestone for any biotech company. Being unprepared can have serious consequences, from costly delays to compliance issues that can jeopardize your entire program. Our team understands the stakes, and we're here to help. Our comprehensive mock inspection process simulates a real regulatory inspection, helping you identify and address potential weaknesses before the actual event. From documentation review to staff interviews, we leave no stone unturned to ensure you will fear no question the inspector will ask you. With our expert guidance and support, you can face your next inspection with confidence, knowing that you've taken every step to ensure compliance. Pass your next inspection with the help of our inspection readiness services. Reach out to Helen Kargaryani or Jacqui Levine to learn how we can support you.

Hello from Rotterdam! Our team is thrilled to be at the TOPRA Symposium, and we’d love to connect with you. If you're attending or nearby, don’t miss the chance to meet Chantal W.M. van Gils, Sigrid Klaar, Tim Hill, and Patrick Mumo.   We are ready to discuss, collaborate, and explore new opportunities. We look forward to seeing you!   #TOPRAsym24

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued a set of high-level principles and recommendations for staff across the European medicines regulatory network (EMRN) regarding the use of large language models (LLMs) in their work. LLMs, a type of generative AI, offer significant potential to support medicine regulators in various tasks, including querying extensive documentation, automating data mining processes, and assisting with administrative duties. However, they also present challenges such as result variability, potential inaccuracies, and data security risks. The newly published guidelines aim to: 📌Build understanding of LLM capabilities and limitations among regulatory staff 📌Promote effective use of LLMs while mitigating risks 📌Provide guidance on safe data input, critical thinking, and output verification 📌Emphasize the importance of continuous learning in this rapidly evolving field The principles also encourage regulatory agencies to support their staff by defining governance for LLM use, specifying permitted use cases, providing training, and monitoring risks. These guiding principles are part of the ongoing efforts to integrate AI technologies in regulatory processes.  https://lnkd.in/e-FZd-r8 #AI #AIdrugdevelopment #EMA