BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:The Latin America Regulatory compliance requirement training/w ebinar will cover topics across the full Life-Cycle of Company &\; Pro duct licensing in the key markets of Latin America [Brazil\, Mexico\, Arg entina]. Written Regulations vs. Skillful Negotiation will be explained a cross every critical topic. The importance of local resources\, Agency me etings and knowing how to navigate the regulatory landscape will accelera te country establishment and successful product licensing\n\nThis course specifically focuses on the overall regulatory compliance requirements an d procedures for Pharmaceuticals\, Medical Devices\, Biologics\, Orphan D rugs and Combination Products in Latin America \;The primary countrie s covered will include: Argentina\, Brazil and Mexico. The course will co ver topics relating to full product life-cycle management and address the structure of the regulatory agencies in Latin America. Content will incl ude descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the au thorization and dossier maintenance of licensed products.\n\nSeminar Agen da\n\nGlossary of Terms.\nDefining the Opportunity: Overview of Latin Ame rica\nCountry Facts: Argentina\, Brazil\, Mexico.\nLatin America's Regula tory Structure for the Life Science Product Industries\nBrazil – ANVISA S tructure &\; Insight to Operations\nMexico – COFEPRIS Structure &\; Insight to Operations\nArgentina – ANMAT Structure &\; Insight to Ope rations\nMercosur - Southern Common Market\nHarmonization Efforts\nBeginn ing Your Company Involvement in Latin America: Examples of Country Requir ements.\nRegistration / Required Country Licenses.\nOverview of the Rules Governing Medicinal Products &\; Medical Devices.\nClinical Trials\, GCP: When are they needed?\nGMP Compliance\nStability Studies: Zonal Uniq ue Requirements\nMarketing Authorization Process &\; Dossier Requireme nts: Pharmaceuticals\nCTD Format Transition\nSummary of Product Character istics\nPackage Inserts\nLabeling Requirements\nAmendments / Variations / Renewals\nMarketing Authorization Processes\n\nGeneric Products &\; B ioequivalence Testing\nBiologics &\; Biosimilars\nOrphan Drug Special Processes\nCompassionate Use / Special Access\n\nMedical Device Registrat ions &\; Product Licenses\nDevice Classifications\nAmendments / Variat ions\nDevice Renewal Applications\nDrug / Device Master File (DMF): Use i n Latin America\nProcessing Variations on Licensed Products.\nLabeling &a mp\; Packaging Leaflet Requirements\nDrug / Device Vigilance &\; Post- Marketing Responsibilities\nImport / Export Procedures\nPatents / Copyrig hts / Trademarks\nAdvertising &\; Promotion of Products\nHow and When to Influence the Regulatory Process.\nThe Regulatory Negotiation Process. \nHow to Use Regulations / Regulatory Contacts to Your Advantage.\nConclu sions\n\nWho Will Benefit:\nThis course will be beneficial to:\n\n\nRegul atory personnel whose responsibilities require knowledge of Latin America ’s regulatory environment.\nAdministrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance req uirements will also find this training highly relevant.\nQA / QC Personne l\nGlobal Supply Chain personnel\nClinical / Pharma &\; Device personn el\nManufacturing personnel\nGlobal Business Development personnel\nAny s ales or general management employee requiring an understanding of how reg ulations and compliance issues impact the organization will also benefit. \n DTEND:20250425T120000 DTSTAMP:20260512T220333Z DTSTART:20250425T090000 LOCATION:\, SEQUENCE:0 SUMMARY:The Latin America Regulatory compliance requirement training/webin ar will cover topics across the full Life-Cycle of Company &\; Product licensin... UID:ac4a8443-6953-4d09-b47c-47895b329a8a END:VEVENT END:VCALENDAR