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

  • 20 Mar 2012
  • Webinar

Description

Latin America`s Regulatory Compliance Requirements for Life Science Products is a webinar that covers topics such as:

  • 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

Latin America`s Regulatory Compliance Requirements for Life Science Products brings together:

  • 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

Past Events

Important

Please, check "Live webinar on Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) By Compliance2go" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Hospitals & Clinics, Medical device, Pharma
Science: Life Sciences & Biology
Technology: Biotechnology

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