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Session 6: Initiatives of Regulatory Convergence
Session Chair(s)
Ana Pineda Zavaleta, MSc
International Regulatory Analyst, LAO, OGPS, OPLIA, OC
FDA, United States
This session is intended to raise awareness in multilateral initiatives of regulatory convergence and how the medical products regulators and stakeholders in the Latin America region could benefit from the guidelines and convergence activities.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Explore training opportunities aligned with ICH and IMDRF
- Obtain greater understanding of the ICH and IMDRF accession process and requirements
- Outline the goals of the APEC RHSC and the benefits from engaging in its activities
Speaker(s)
Speaker
Jared Auclair, PhD
Northeastern University, United States
Vice Provost Research Economic Development; Director Bioinnovation
ANMAT Engagement in the IMDRF
Mariela Aranda
ANMAT, Argentina
Head of IVD department
APEC Regulatory Harmonization Steering Committee and Centers of Excellence
Michelle Limoli, PharmD, RPh
FDA, United States
Senior International Health Science Advisor, Office of the Director, CBER
INVIMA’s Experience on Medical Devices Regulation and Engagement to the IMDRFF
Mabel Romero
INVIMA, Colombia
Directorate of Medical Devices and Other Technologies
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