Luis Gerardo Alcala Carmona
Universidad Nacional Autonoma de Mexico, Mexico
Biography
Luis Gerardo Alcala Carmona is a regulatory affairs expert based in Mexico City. During his career, he has shown a strong devotion to bringing into the market medical supplies of the best quality that are safe and effective for the patients. He has built differently proven regulatory strategies for national and international companies, having been able to collaborate with companies from around the World, such as the USA, Brazil, Argentina, Chile, Colombia, France, Germany, The UK, Italy, China, Japan, South Korea, among others. His expertise line includes medical devices, medical drugs, and biotechnology drugs, which include generic and innovative drugs. Having worked with new registers, variations, and renewals. Having been able to collaborate directly with Big Pharma Company, Luis also specializes in newly formed companies, always focusing on the best possible regulatory path and having in mind the safety of the patients, as he always says “We are all potential patients”.
Abstract
Abstract : Innovations in biosimilars: Ensuring quality from a regulatory angle