We are excited to announce our partnership with the US FDA to bring you the DIA-US FDA Biosimilars Conference on 3-4 February 2025 in Hyderabad, India. This joint program offers a unique opportunity to hear from FDA subject matter experts on current regulatory perspectives on various topics related to biosimilar application life-cycle management including: ◾ Biosimilar review process ◾ FDA data expectations ◾ Interchangeability ◾ Common review deficiencies ◾ Post approval changes ◾ Inspections and observations ◾ Best practices and real-world examples Join us for valuable insights and strategies to navigate the evolving biosimilars landscape with experts from regulatory, industry and academia. Save the date (https://bit.ly/4fq2eDn) and stay tuned for more details! #DIAUSFDA2025 #Biosimilars #RegulatoryAffairs #Biotech #Pharmaceuticals
Regulatory & Pharmacovigilance Pharmacist at Square Pharmaceuticals PLC.
2dDIA You should arrange a program for generic manufacturers (ANDA) or regarding Bio Equivalance study challenges and outcome or sterility assurance and requirements for submission.