Lachman Consultant Services

READ: Nitrosamines Harmonization: The Conversation Continues… https://lnkd.in/em7A-Mv7 #FDA #Nitrosamines #Generics #OGD #RegulatoryAffairs Author: Jennifer Leaming

Day Three of the AAM GRx-Biosims Conference https://lnkd.in/geCSFVzH #Bioequivalence #Biosimilars #FDA #Generics #OGD #RegulatoryAffairs Association for Accessible Medicines #GRxBiosims

AAM Brief Look Back at Day One and Some Thoughts on Day Two https://lnkd.in/geYw9fcD #Bioequivalence #Biosimilars #DataIntegrity #Generics #OGD #RegulatoryAffairs Association for Accessible Medicines #GRxBiosims

📣 #GlobalAccess2024 starts tomorrow, and Lachman Consultants is excited to be sponsoring this exceptional event! ✨ Connect with Martha Ni Chuanaigh at the Lachman table to learn about our extensive 🌍global capabilities in the Medtech space. For more information about what Lachman has to offer in the Medtech space, take a look at our website here: https://lnkd.in/eEh_S4Hn For more information about the conference, please see the website here: https://lnkd.in/ecJsV_F Excerpt from the Global Access website about this year's conference: "Global Access is Ireland’s largest and most comprehensive medical technology industry QA/RA conference. Organised by the Irish Medtech Association, the 9ᵗʰ edition of Global Access brings together national QA/RA experts, policy makers, regulators and representatives of the global medical technology industry." Irish Medtech #Medtech #Regulatory #Quality #Ibec

OGD Official Statistical Report for August 2024, Plus Mid-Month October 2024 Approval Actions https://lnkd.in/e8JxphZf #Approvals #FDA #Generics #OGD #RegulatoryAffairs

AAM’s GRx-Biosims Conference – Highlights from Day One Association for Accessible Medicines #GRxBiosims https://lnkd.in/eTx5twtP Don't miss our coverage of the #AAM GRx+Biosims meeting happening this week! #Pharma #Generics #Biosimilars #DrugShortages #SupplyChain

✨ The GRx + Biosims Conference by Association for Accessible Medicines is next week! ✨ Don't miss the learning track session on #DrugShortages moderated by Marty Shimer, Executive Director at Lachman Consultants. Our team will have a table in the exhibit hall full of useful information, stop by and say hello! Michele Sinoway will be on site to answer your questions along with other subject matter experts from team Lachman. More info on this session here: https://lnkd.in/ePEaNSJG #RegulatoryAffairs #Compliance #Quality #Biosimilars #Generics #FDA #GRxBiosims #GRxBiosims2024

BLOG: After Lawsuit, FDA to Reconsider Tirzepatide Shortage Issue – the Saga Continues https://lnkd.in/eg45BvNR #Compounding #RegulatoryAffairs

📣 DID YOU MISS IT? This week at the ISPE Annual Meeting, Becky Welton spoke about the world of #503B compounding. ✨ From the Meeting Agenda: "Join us for an engaging discussion into the critical facets of 503B compounding at this year's ISPE Annual Conference through a panel comprised of industry experts. This session begins with a comprehensive overview of the ISPE Guide related to 503B compounding, setting the stage with foundational knowledge and industry standards. The following presentation will address the practical aspects of implementing a deviation and investigation program, providing attendees with actionable insights on managing compliance effectively. Concluding the panel, we will hear from industry experts on the regulatory perspectives that shape 503B compounding practices..." If you have questions related to this topic, please reach out to us at lcs@lachmanconsultants.com, or send us a message here on LinkedIn. 

Lachman Consultant Services is proud to be sponsoring The MedTech Conference as a member of AdvaMed. Take a look at the event exhibit floor here! #mtc24 #medtechcon #medtechinmotion