Claudia Saidman

ANMAT-National Administration of Medicines, Food and Medical Technology

Claudia is a physician specialized in internal medicine, pharmacology, medical audit and forensic medicine. She teaches pharmacology at University of Buenos Aires Medical School. She worked for 27 years at ANMAT - Argentinean Administration Food Drugs and Medical Technology - as Head of the Division for Clinical Pharmacological Evaluation, leading the evaluation and commercialization approval of medicines authorized under special conditions. Claudia also continues her medical practice at Hospital de Clínicas Jose de San Martin which depends on University of Buenos Aires. She is a member of the American College of Clinical Pharmacology (ACCP), and has participated in the following international regulatory meetings:
• Health Products and Food Branch (HPFB) International Regulatory Forum Program, in October 2011
• 16th CDER Forum for International Drug Regulatory Authorities, in June 2013 as speaker in Orphan Drugs
• 2da Reunión Latinoamericana de Plasma y Hemoderivados, in October 2017 as speaker in National Regulations for clinical studies on biological products
• Well Characterized Biotechnology Products (WCBP) 22nd Symposium, in February 2018 as speaker in Advantages and Challenges of Working with Non-ICH Countries and Rare diseases and expedited review regulations
• WCBP 23rd Symposium, in January 2019 as speaker in Current Regulatory Trends and Hot Topics Around the Globe
• CMC STRATEGY FORUM LATIN AMERICA 2019, in March 2019 as speaker in Trends in the Development of Biological and Biosimilar Products in Argentina
• Reunión de Autoridades Reguladoras Nacionales de Referencia Regional OPS/OMS (ARNr), in May 2019 as speaker in Registry of medicines authorized under special conditions.
• WCBP 24th Symposium, in January 2020 as speaker in Accelerated Approval for Medicines in Rare and Serious Diseases