Neetha Suresh’s Post

"Don't miss out on our upcoming MasterClass! Learn about current & proposed post-authorisation obligations in the EU & UK. #PostMarketingSurveillance #PharmaRegulations" Event - EU and UK procedures for marketing Authorization online Masterclass Date - 25-26 June,2024 Led by - Norah Lightowler For more details - neetha.suresh@glceurope.com | DM Limited seats Available!! #EURegulations #UKRegulations #PharmaRegulations #DrugDevelopment #MarketingAuthorization #ClinicalTrials #LifeSciences #PharmaCompliance #MasterClass #USPharma

🔍 Vietnam's Draft Law on Pharmacy: Key Insights and Next Steps 🔍 Vietnam’s National Assembly recently held a detailed discussion on the draft amendments to the Law on Pharmacy, focusing on pivotal reforms to enhance drug affordability, promote local manufacturing, and streamline distribution channels. These changes underscore the government’s dedication to building a transparent, accessible, and resilient healthcare system (source). Key Outcomes of the Discussion: - Stricter Drug Price Regulations: Measures for better price control aim to improve affordability and transparency in the pharmaceutical market. - Boosting Local Manufacturing: New policies will encourage domestic production, helping reduce reliance on imports and foster local pharmaceutical innovation. - Improving Distribution: Streamlined distribution regulations will expand medication access, especially in rural areas. Next Steps: The draft law will undergo further review and fine-tuning, incorporating feedback from stakeholders, including healthcare professionals and pharmaceutical companies. The finalized amendments are expected to be presented for approval in the next legislative session, paving the way for formal implementation. Vietnam’s proactive legislative approach represents a meaningful step towards an equitable and efficient healthcare system. The upcoming reforms hold promising potential for local and international stakeholders within the Vietnamese pharmaceutical market. Source: #VietnamPharmacyLaw #HealthcareReform #NextSteps #Pharmaceuticals #NationalAssembly #EmergingMarkets

The marketing practices of pharmaceutical companies has been a topic of hot debate for years. It's common for pharma reps to give lavish gifts to doctors and medical professionals in the hopes that they will prescribe their drugs to their patients. The Department of Pharmaceuticals has now notified the Uniform Code for Pharmaceutical Marketing Practices 2024. It supersedes the code of 2014, and while it is not currently in force, the new code will provide clarity on the nature of items and value of items that may be supplied to healthcare professionals. Gone are the days when pharma companies would pretty much sponsor travel, hotel accommodation, and other expenses of healthcare professionals' vacations under the guise of "marketing" practices. #pharmaceuticalcompanies #pharma #legalupdates 

Real-World Evidence: A New Frontier in Pharma Published by: Food and Drug Administration, March 2024, in #USA. Considerations: 🔺 Emphasizes the use of real-world evidence (RWE) for demonstrating drug effectiveness and safety. 🔺 Highlights the importance of non-interventional study design and analysis considerations. 🔺 Stresses the significance of reliability and relevance of real-world data (RWD) in regulatory decision-making. 🔺 Underlines the need for prespecification of study design and early engagement with the FDA. 🔺 Points out the utility of electronic health records and medical claims data in supporting regulatory decisions. #FDA #RealWorldEvidence #DrugSafety #RegulatoryScience #pharma #pharmaceutical

What an exciting and dynamic discussion! Debating the New EU Pharma Legislation in the Danish Parliament Today 💊🇪🇺 Strong voices raised important questions, with one standout: Should we have a Europe-wide Amgros? 🤔 This could have a profound impact on costs, availability, and accessibility of medicines across the EU. Many question whether our role in the equation could be developed and become a more powerful force in the areas of purchasing, forecasting, and contracting pharmaceutical products. Maybe not just in the hospital sector... By doing so, could we build a more competitive and stable market that benefits all European citizens? 💡 #Pharma #EUlegislation #Sykehusinnkjop #NPF Outstanding Flemming Sonne

How are the proposed new EU pharma rules going to impact the life sciences and healthcare sector?   Industry representatives say they will reduce access to innovative treatments for European patients and there is concern that companies will spend less on R&D in Europe. It is important for pharma companies to continue to engage over the coming months and to keep a close eye on legislative developments.   Catch-up on our EU pharma package webinar here: https://lnkd.in/d7nVMhBk CMS Life Sciences & Healthcare Sector #CMSlaw #law #regulatory #eupharmapackage #pharmaceuticals #lifesciences #healthcare

The government's emphasis on modernizing pharmaceutical and MedTech regulatory standards is a step in the right direction toward achieving higher healthcare standards. We are looking for industry input to make the necessary changes. Visit our website www.nkgabc.com to know more To start your registration process: Email- navraj@nkgabc.com or call 9711197602 Reach out today and follow us on LinkedIn, Twitter, Instagram, Pinterest and Youtube for expert tips and industry updates. Source :- https://lnkd.in/eCw2wRTg LinkedIn News LinkedIn LinkedIn News India #NKGabc #ProductSafety #Goverment #Regulatory #Globalbusiness #Regulatoryupdates

Our latest position paper on EU Pharmaceutical Legislation revision is out now! 📄💊 🆕   🇪🇺 With a focus on enhancing patient safety and access, we're advocating for legislation that truly meets the evolving demands of healthcare in the digital age.   🔦 Our position paper addresses the crucial role of digital solutions in ensuring accessible medicines and healthcare services, spotlighting the need for a true Single Market for medicines.   ⏰ With many EU citizens supporting the possibility to obtain medicines digitally, it is time for EU institutions to ensure that every patient has equal access to healthcare.   Dive into our position paper and discover our vision for a more inclusive, convenient, and integrated healthcare system 👉 https://lnkd.in/dWPfEZsm   #DigitalHealth #PharmaceuticalPackage

[Legal Update] The amended Law on Pharmacy, set to take effect on July 1, 2025, marks a pivotal development for Vietnam’s pharmaceutical sector. This significant legislation is expected to bring substantial changes to the local market, creating new opportunities for businesses while fostering a more dynamic and competitive industry landscape. In this article, our Senior Associate Ngo Thanh Hai provides a comprehensive analysis of the key amendments, offering invaluable insights into their implications. Hai delves into how these changes are designed to bolster domestic pharmaceutical production, facilitate the transfer of cutting-edge technology, and introduce attractive investment incentives for manufacturing projects. His in-depth commentary sheds light on how these reforms aim to enhance Vietnam’s pharmaceutical capabilities, paving the way for sustainable growth and innovation in the sector. Whether you are a stakeholder in the pharmaceutical industry or an investor exploring new opportunities, Hai’s thorough exploration of these amendments will provide you with the clarity and guidance needed to navigate this evolving regulatory landscape. Read the full article at: https://lnkd.in/g_cSfQRk #LNTPartners #PharmaceuticalLaw

مرحب جدا بالاضافه (ICH) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use The ICH topics are divided into the four categories 1-Quality Guidelines 2-Safety Guidelines 3-Efficacy Guidelines 4-Multidisciplinary Guidelines