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Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar

Event Details

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar

Time: January 15, 2014 at 8:30am to January 16, 2014 at 4:30pm
Location: Grand Hyatt San Francisco, CA
Street: 345 Stockton Street
City/Town: San Francisco
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: biotech, and, pharmaceutical
Organized By: ComplianceOnline
Latest Activity: Dec 10, 2013

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Event Description

Course Description:

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.

 

Why You Should 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 as Chile, 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 the wide array 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 Healthcare Authorities. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.

 

Who will Benefit

This course will be beneficial to:

 

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

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