Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Aug 02, 2016
Length
90 minutes
Product Description

Compliance Requirements for Medical Devices, Biologics, Pharmaceuticals, Biosimilars and More in Latin America

If you are an American life science company doing business in Latin America, you must now the regulatory compliance requirements and procedures in the region. Especially, you must be aware how Latin America interacts and utilizes ICH standards—and how they relate with other regulatory agencies.

Join this webinar by expert speaker Robert J. Russell to get a better understanding of life science industry regulatory compliance in Latin America. This session will cover topics across the entire lifecycle of licensing a company or product(s) in key markets of the region. Robert will demonstrate whether written regulations or skillful negotiation can help you in every critical topic. You will understand the importance of local resources and agency meetings. Additionally, you’ll know how to navigate the regulatory landscape and accelerate country establishment and product licensing.

The session focuses especially on the overall compliance procedures and requirements dealing with Medical Devices, Biologics, Pharmaceuticals, Orphan Drugs, Biosimilar and combination products in the Latin American market (especially, Argentina, Mexico and Brazil). You will learn in details about full product life-cycle management, and know the regulatory agency structures in Latin America. You will get the description of methods used by regulators when they fill processes and register with corresponding agencies, and understand what is to be expected in authorization and dossier maintenance of licensed products.

Know the current regulatory climate in Latin American and get several examples which will illustrate effective compliance techniques and procedures. The presentation highlights common issues that have caused difficulties for Life Sciences firms in the region. Learn how Latin America utilizes and interacts with ICH standards, and understand how they are related with other national regulatory agencies. Also, the session will explain how personnel can address conflicts better.

Session Highlights:

  • Glossary of Terms.
  • Defining the Opportunity: Overview of Latin America
  • Country Facts: Argentina, Brazil, Mexico.
  • Latin America's Regulatory Structure for the Life Science Product Industries
  • Brazil – ANVISA Structure & Insight to Operations
  • Mexico – COFEPRIS Structure & Insight to Operations
  • Argentina – ANMAT Structure & Insight to Operations
  • Mercosur - Southern Common Market
  • Harmonization Efforts
  • Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
  • Registration / Required Country Licenses.
  • Common Fees
  • Overview of the Rules Governing Medicinal Products & Medical Devices.
  • Clinical Trials, GCP: When are they needed?
  • GMP Compliance
  • Stability Studies: Zonal Unique Requirements
  • Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
  • CTD Format Transition
  • Summary of Product Characteristics
  • Package Inserts
  • Labeling Requirements
  • Amendments / Variations / Renewals
  • Marketing Authorization Processes
    • Generic Products & Bioequivalence Testing
    • Biologics & Biosimilars
    • Orphan Drug Special Processes
    • Compassionate Use / Special Access
  • Medical Device Registrations & Product Licenses
  • Device Classifications
  • Amendments / Variations
  • Device Renewal Applications
  • Drug / Device Master File (DMF): Use in Latin America
  • Processing Variations on Licensed Products.
  • Labeling & Packaging Leaflet Requirements
  • Drug / Device Vigilance & Post-Marketing Responsibilities
  • Import / Export Procedures
  • Patents / Copyrights / Trademarks
  • Advertising & Promotion of Products
  • How and When to Influence the Regulatory Process.
  • The Regulatory Negotiation Process.
  • How to Use Regulations / Regulatory Contacts to Your Advantage.
  • Recent Country Legislation: New Regulations
  • Conclusions
  • Resources / Helpful Websites.

Who Should Attend

  • Regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment.
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
  • QA / QC Personnel
  • Global Supply Chain personnel
  • Clinical / Pharma & Device personnel
  • Manufacturing personnel
  • Global Business Development personnel
  • Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.


Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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