Understanding Regulatory Compliance Requirements Across the Life Science Industry

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Category Webinar,Understanding Regulatory,Compliance Requirements

Deadline: September 19, 2014 | Date: September 19, 2014

Venue/Country: Phoenix, U.S.A

Updated: 2014-08-20 05:02:16 (GMT+9)

Call For Papers - CFP

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Course Objective:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico.

Course Outline:

? 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

Target Audience:

? 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

Webinar Price Tags :

$ 229.00 Single Attendee

$ 799.00 Group ? Max 10 Attendees per location

$ 299.00 Access Recorded Version online

$ 399.00 Buy Training CD-DVD

For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

Fax : +1-888-883-7697

E-mail ID : webinarhelpcomplianzworld.com