2014-08-04 08:01:34 -
Why 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.
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 session
Location: Your office or conference room (no need to travel!)
Certificate of Attendance
Areas 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 Industries
Mercosur - Southern Common Market.
Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
Registration / Required Country Licenses.
Overview of the Rules Governing Medicinal Products & Medical Devices
Select 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 & Registrations
Drug vs. Medical Device vs. Biologic vs. Combination Product
Drug Master File (DMF) Use in Latin America Registration
Use of Expert Reports.
Processing Variations on Licensed Products
Variations: Changes to Marketed Products.
Types of Variations.
Dossier Maintenance Expectations.
Changes Concerning Manufacturing Aspects (Product & Process).
Labeling & Packaging Leaflet Requirements
Orphan Drugs / Rare Diseases
Comparing and Contrasting Latin American Procedures vs. the U.S. FDA
Comparison of Processes.
How and When to Influence the Regulatory Process
Accepted Country Practices.
Effective Monitoring Activity.
Association vs. Individual Company Involvement & Intervention.
The Regulatory Negotiation Process
The Do's and Don'ts of Regulatory Involvement.
How to Use Regulations / Regulatory Contacts to Your Advantage
Business Impact Within and Outside Latin America.
Professionalism in Regulatory Lobbying.
Resources / Helpful Websites
Who Will Benefit:
This course will be beneficial to:
Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment
Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
QA / QC Personnel
Global Supply Chain personnel
Clinical / Pharma & Device personnel
Global Business Development personnel
Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization