Maria de la Luz Lara MéndezCEO at Udelá
Profile
Maria is the CEO of Udelá, a comprehensive regulatory services and consulting company in Mexico and LATAM, located in Mexico and Colombia with presence in Central America and LATAM, and holds more than 15 years of experience in Regulatory affairs in the private and public sectors. Having worked at the National Regulatory Agency of Mexico (COFEPRIS) for over 10 years in various director-level positions, Maria has had a key role in the development of official standards, regarding Biotechnological products and pharmacovigilance, and has acted as a COFEPRIS representative at various international forums such as, the Pacific Alliance, International Pharmaceutical Regulators Forum (IPRF), The International Generic Drug Regulators Pilot (IGDRP) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Additionally, she is a professor of Regulatory Affairs and Administration at La Salle University.
Agenda Sessions
Chairperson’s Opening Remarks
, 09:00View SessionIntroduction to Medical Devices in Latin America
, 09:05View SessionOverview of regulatory procedures in Brazil, Mexico, Argentina and Colombia
, 09:30View SessionOvercoming regulatory challenges in Brazil, Mexico, Argentina and Colombia and specific device issues
, 10:55View SessionChairperson’s Opening Remarks
, 13:25View SessionWorking with local consultants, host companies and distributors
, 13:30View SessionImportant requirements in Latin America
, 15:45View Session