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MedTech Summit

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19 - 23 June 2023
Sheraton Brussels Airport HotelBrussels, Belgium (Hybrid Event)

Maria de la Luz Lara Méndez
CEO 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

    09:00
  • Introduction to Medical Devices in Latin America

    09:05
  • Overview of regulatory procedures in Brazil, Mexico, Argentina and Colombia

    09:30
  • Overcoming regulatory challenges in Brazil, Mexico, Argentina and Colombia and specific device issues

    10:55
  • Chairperson’s Opening Remarks

    13:25
  • Working with local consultants, host companies and distributors

    13:30
  • Important requirements in Latin America

    15:45