MS PHARMA’s Post

USFDA Published Draft guideline for use of Artificial Intelligence (AI) in Jan 2025 for making Drug products and Biological Products : #Compliance #AI #Biologics #Pharmaceuticals

(Benefit-Risk Management / FDA Labels / US FDA Tool Updated V2.9 Release) Today is a tool highlight - ever been in "FDALabel"? It's a tool that's been around for a while that allows you to search the text of US FDA approved product labels. Example of use: you've come across an AE, want to know what other product has that AE? Have a special indication and want to explore what are the other products that's been approved with that indication. Play a bit to understand the full power of this amazing tool. Enjoy. #fda #cder #cber #drugs #biologics #fdatools (P.S. loved this tool since I first saw it, about 10yrs ago!)

Pharma companies doing business in #China have 4 key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them. https://lnkd.in/eFUEPCNc By 王晓敏/April Wang, Accestra Consulting #drugapproval #biologics

The FDA's recent draft guidance on the use of AI in drug and biological product development marks a significant advancement in the integration of AI within the pharmaceutical industry. This initiative underscores the FDA's commitment to fostering innovation while maintaining rigorous scientific and regulatory standards. #AI #ArtificialIntelligence #fda #drugdevelopment #Regulatory #Biologics

#Simcyp #PBPK Simulator V23 helps streamlines drug development with: #Regulatory compliance #Improved #DDI prediction #Broader #biologics support #Virtual #bioequivalence simulation Benefits: Faster, safer #drugdevelopment #drugdevelopment #pharma #innovation #Simcyp

Registering biologics in the RoW region is complex owing to multiple subcategories. Freyr's biologics registration services help understand the Regulatory framework for each subcategory and hasten market entry. Click here to know more. https://lnkd.in/gxw55hQZ #Biologics #RegistrationServices #RegulatoryAffairs #RoW #FreyrSolutions

Announcing our key speaker Sweety Mathew, Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases, Novo Nordisk for Virtue Insight's #Biosimilars Congregation 2024 https://lnkd.in/ghbuJCf6 For our upcoming conferences visit : https://lnkd.in/gjQY86dn #VIbsc #virtueinsightbiosimilars #FollowonBiologics #Biologics #Biotherapeutics #Biopharmaceuticals #LegalAffairs #IntellectualProperty #ClinicalImmunology #Regulatory #Biotechnology #Biogenerics #lifesciences #pharmaceuticals #pharmaceuticalindustry #pharmanews #pharma #regulatoryaffairs #lifesciences #healthcare

Expanding my horizons in pharma marketing! Attended the insightful "Changing Face of Pharmaceutical Marketing in the Era of Biologics and Vaccines" workshop at Institute of Engineering and Management. Excited to apply learnings and stay updated on industry trends! #pharmamarketing #biologics #vaccines

Announcing our key speaker Dr. Akshaya S. Odak, Head - Regulatory Affairs (Biotech), Lupin for Virtue Insight's #Biosimilars Congregation 2024 https://lnkd.in/ghbuJCf6 For our upcoming conferences visit : https://lnkd.in/gjQY86dn #VIbsc #virtueinsightbiosimilars #FollowonBiologics #Biologics #Biotherapeutics #Biopharmaceuticals #LegalAffairs #IntellectualProperty #ClinicalImmunology #Regulatory #Biotechnology #Biogenerics #lifesciences #pharmaceuticals #pharmaceuticalindustry #pharmanews #pharma #regulatoryaffairs #lifesciences #healthcare