Live webinar on Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) By Compliance2go 2012

Topics

• Defining the Opportunity
• Glossary of Terms
• Latin America`s Regulatory Structure for the Life Science Product Industries
• Country Facts: Argentina, Brazil, Mexico
• Examples of Country Requirements in Latin America - Beginning Your Company Involvement
• Mercosur - Southern Common Market
• Common Fees
• Registration / Required Country Licenses
• Marketing Authorization Processes - Filings & Registrations for Drugs, Medical Device, Biologic and Combination Products
• Overview of the Rules Governing Medicinal Products & Medical Devices
• Use of Expert Reports
• Drug Master File (DMF) Use in Latin America Registrations
• Labeling & Packaging Leaflet Requirements
• Processing Variations on Licensed Products
• Comparing and Contrasting the U.S. FDA. and Latin American Procedures
• Orphan Drugs / Rare Diseases
• Use of Regulations / Regulatory Contacts to Your Advantage
• The Regulatory Negotiation Process

Who should Attend

• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
• Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment
• Global Supply Chain personnel
• QA / QC Personnel
• Manufacturing personnel
• Clinical / Pharma & Device personnel
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization
• Global Business Development personnel