Marius Roemer’s Post

Pharma Policy and What's Next? As pharma faces calls for greater transparency and competitive pricing, the implications are vast. PharmaVoice provides the latest on policy discussions that could reshape the landscape—from FDA and FTC regulations to drug pricing debates. Read the article: https://hubs.li/Q02XPw-50 #PharmaPolicy #DrugPricing #FDA #PharmaNews

Modernization Efforts Are Streamlining Regulatory Processes, FDA Report Finds: The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining staff, according to a new CDER report. #fda #financial #lifesciences

Watch our TOPRA - The Organisation for Professionals in Regulatory Affairs sponsored webinar: Integrated Pharma Regulatory Strategy as the Key to Market Advantage. Are you struggling with a fragmented regulatory approach that’s slowing down your innovative therapies? This webinar will equip you with the power of an Integrated Pharma Regulatory Strategy. Our experts will reveal how to: * Unify your regulatory efforts for a streamlined path to market. * Minimize risks and navigate complex frameworks with confidence. * Shave valuable time off your development timeline. Click here for the full recording and access to the slides. https://lnkd.in/eJ8_frHF Kate Coleman Jayne Hunt Sam Tomlinson Sandra Lourenço Erik Smit #pharma #regulatory #quality

Integrated Pharma Regulatory Strategy as the Key to Market Advantage. Are you struggling with a fragmented regulatory approach that’s slowing down your innovative therapies? This webinar recording from Arriello and TOPRA reveals how to: * Unify your regulatory efforts for a streamlined path to market. * Minimize risks and navigate complex frameworks with confidence. * Shave valuable time off your development timeline. Click here for the full recording and access to the slides. https://lnkd.in/eJ8_frHF #pharma #regulatory #quality

It’s always interesting to watch how policy changes might affect pharma. The recent push for more transparency and competitive pricing has many potential impacts across the industry. PharmaVoice recently shared updates on the current dialogue around regulatory shifts in the FDA, FTC, and drug pricing initiatives. If you’re following these developments closely, the article is worth a read: https://hubs.li/Q02XPLqV0 #PharmaPolicy #DrugPricing #FDA #PharmaNews

check out this new draft guidance for drug-device combo products

📣 Register to our webinar: Drug Device Combinations in the EU & Article 117 👉 Register here: https://lnkd.in/ehY3ZBTY 📅 November 26, 3PM CET Are you planning to submit your Drug Device combination as a medicinal product in the EU? How to address the Medical Device part? What is Article 117 of the Medical Device Regulation and how to use it? Eline Dirven and Tom Manussen will guide through the most important aspects to support you with a successful registration of your Drug Device combination. Save your spot now to our monthly Zwiers Regulatory Consultancy BV, a ProductLife Group company, webinar: #pharma #drug #medicaldevice #drugdevice #healthcare #webinar #lifescience #regulatory #compliance

Learn how to navigate Article 117 and ensure a successful Drug-Device Combination registration in the EU. Don’t miss insights from Eline Dirven and Tom Manussen! #DSI #DrugDevice #Pharma #RegulatoryCompliance #Healthcare #MedicalDevices #Webinar

The Drug Approval Journey: From Lab to Market 1. Pre-clinical Studies – Assess initial safety of the drug before testing in humans. 2. IND Application – Obtain regulatory approval to start human trials. 3. Clinical Trials (Phase I-III) – Test the drug in humans to evaluate safety, effectiveness, and proper dosage: 4. Phase I – Small group, focused on safety. 5. Phase II – Larger group, tests effectiveness and side effects. 6. Phase III – Large-scale testing for final safety and effectiveness. 7. NDA/BLA Submission – Apply for market approval after successful trials. 8. Phase IV Trials – Monitor long-term safety once the drug is available to the public. Each step is essential to ensure new drugs are safe, effective, and meet strict regulatory standards. #DrugApproval #ClinicalTrials #Pharma #DrugDevelopment #Healthcare #QualityAssurance #PublicHealth #Innovation

Don't stress the regulatory registration: We navigate you for a seamless GLP-1 journey. 🚀   After you choose the ideal drug containment or drug delivery solution, SCHOTT Pharma will support you throughout the regulatory registration process. What we take care of: Your selected product has regulatory availability in all countries where you intend to go to market. Different countries follow different registration processes, and we will prepare you and your product to meet compliance with the respective international norms and standards, as well as country-specific laws and guidelines. Streamlining regulatory processes can lead to faster time-to-market. Focus on your core business and be ready for GLP-1-based drugs. We are ready.   Find out more here: https://lnkd.in/eqCqH7Cg   #GLP1 #patientsafety #health