THURSDAY APRIL-3-2014

12:00 PM TO 01:30 PM - EST EST DURATION: 90 MINUTES

Live webinar on "Latin America: Regulatory Compliance Requirements

for Life Science Products (Focus: Brazil, Mexico, Argentina)"
DESCRIPTION
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 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.

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.
Common Fees.

Live
One Dial In - One
$189Attendee
One Dial In Unlimited
attendance (To be
arranged in a
$249Conference
room/Meeting
room. Note : Only
One Dial In
Allowed)

Combo
Combo 1 (One Dial
In - Unlimited
$329attendance + On
Demand Recorded
Session)
Combo 2 (One Dial
In - Unlimited
$349
attendance +
Training CD)

Recorded
On Demand ( 90
Days of online
$289Streaming access
available after the
live session )
Play Back Unlimited Views
( Recorded file
$319
available for
download after the
live session )
Get Training CD
$359

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
Manufacturing personnel
Global Business Development personnel
Any sales or general management employee requiring an understanding of
how regulations and compliance issues impact the organization.
Webinar Includes:
Q/A Session with the Expert to ask your question
Handouts (PDF print only copy of PowerPoint slides)
90 Minutes Live Presentation
Certificate of Attendance

For any assistance contact us at support@compliance2go.com or call us

at 877.782.4696 Or Visit us:- https://www.compliance2go.com/product/?

pid=CP2014-292
Multiple
Location
$109 Multiple location
9
- Up to 5 Dial in
$499 allowed