Latin America ? Understanding Regulatory Compliance Requirements Across the Life Science Industry
Website https://compliance2go.com/product/?pid=CP2014-384 |
Category Medical Device
Deadline: January 15, 2027 | Date: January 15, 2027
Venue/Country: Houston, U.S.A
Updated: 2014-12-09 19:14:08 (GMT+9)
Call For Papers - CFPDESCRIPTIONWhy Should You Attend: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such asChile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution. Webinar Includes:Online course manual available for free with your purchase!And remember, you’ll get a chance to ask your toughest questions during the Q&A sessionLocation: Your office or conference room (no need to travel!)Certificate of AttendanceAreas Covered in the Seminar:Glossary of Terms.Defining the Opportunity.Country Facts: Argentina, Brazil, Mexico.Latin America's Regulatory Structure for the Life Science Product IndustriesMercosur - Southern Common Market.Beginning Your Company Involvement in Latin America: Examples of Country Requirements.Registration / Required Country Licenses.Common FeesOverview of the Rules Governing Medicinal Products & Medical DevicesSelect Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.Marketing Authorization Processes - Filings & RegistrationsDrug vs. Medical Device vs. Biologic vs. Combination ProductDrug Master File (DMF) Use in Latin America RegistrationUse of Expert Reports.Processing Variations on Licensed ProductsVariations: Changes to Marketed Products.Types of Variations.Dossier Maintenance Expectations.Changes Concerning Manufacturing Aspects (Product & Process).Labeling & Packaging Leaflet RequirementsOrphan Drugs / Rare DiseasesComparing and Contrasting Latin American Procedures vs. the U.S. FDAComparison of Processes.Agency Interactions.Accepted Practices.How and When to Influence the Regulatory ProcessAccepted Country Practices.Effective Monitoring Activity.Association vs. Individual Company Involvement & Intervention.The Regulatory Negotiation ProcessEffective Approaches.The Do's and Don'ts of Regulatory Involvement.How to Use Regulations / Regulatory Contacts to Your AdvantageCheck-in Procedure.Agency Interactions.Business Impact Within and Outside Latin America.Professionalism in Regulatory Lobbying.Resources / Helpful WebsitesWho Will Benefit:This course will be beneficial to:Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environmentAdministrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements QA / QC PersonnelGlobal Supply Chain personnelClinical / Pharma & Device personnelManufacturing personnelGlobal Business Development personnelAny sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization
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