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.
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.
This course will be beneficial to:
Note: Use coupon code 232082 and get 10% off on registration.
For Registration - http://www.complianceonline.com/latin-america-regulatory-compliance-requirements-for-life-science-products-focus-brazil-mexico-argentina-seminar-training-80016SEM-prdsm?channel=pickevent
Course Description: Importing products regulated by the FDA...
Q
Course Description: Quality control and related contract laboratories are...
Q
Course Description: Are the financial transactions within your organization...
Q
Course Description: Analytical instruments should be qualified and systems...
Q
Course Description: Analytical methods and procedures should be validated to...
Q
Course Description: This course will highlight the need for all businesses to...
Q
Course Description: A growing public demand for supplements...
Q
Course Description: The objective of this two day "Essentials...
Q
Course Description: This interactive one and a half day seminar is intended to...
Q
Course Description: Gain in-depth knowledge on Harmonized Tariff Schedules and...
Q
Course Description: With FDA citing inadequate change control constantly in...
Q
Course Description: The topic of fraud — whether it relates to awareness and...
Q
Course Description: Recent scandals as well as legal and regulatory actions...
Q
Course Description: The question asked by many companies is “How can we gain...
Q
Course Description: Fraud perpetrated by insiders far outstrips fraud by...
Q
Course Description: This course is designed to introduce to...
Q
Course Description: Microbiology plays a role throughout the manufacture of...
Q
Course Description: Although financial institutions have been managing BSA...
Q
Course Description: The audit report represents the end result of weeks of...
Q
Course Description: Patient safety in clinical trials and the safety of...
Q
Course Description: The variety and complexity of risks facing today's...
Q
Course Description: In this two day workshop conference you...
Q
Course Description: This GRC Professional Seminar will teach you how to...
Q
Course Description: Manufacturing an investigational product for the initial...
Q
Course Description: This course provides specific and concrete instruction...
Q
Aims: Fraud figures high on the list of operational risks that face all banks...
Q
Course Description: Bribery can often damage your business and your...
Q
Course Description: This comprehensive interactive training...
Q
Course Description: The various regulatory agencies have expectations that...
Q
Aims: A 2-day intensive course on business continuity and scenario planning...
Q
Aims Recently, a series of headline-grabbing operational risk incidents at...
Q
Course Description: It’s never been more challenging to find and hire the...
Q
Course Description: HIPAA Now and Then The evolutions of this enigmatic law...
Q
Course Description: All facilities manufacturing pharmaceuticals, biologics,...
Q
Course Description: The course is designed for Medical Products Manufacturers....
Q
Course Description: Is your company at risk for non-compliance? Is your...
Q
Course Description: This interactive two-day course will explore proven...
Q
Course Description: The growth of the medical software industry outpaces the...
Q
Course Description: This China & Pacific Rim life science compliance-based...
Q
Key Attraction Innovate novel ideas for advancements in medical device...
Q
Course Description: Organizations of all kinds and sizes are...
Q
Course Description: This Computer System Validation Training course will...
Q
Course Description: Is your company at risk for non-compliance of FMLA...
Q
Course Description: In every laboratory inspection there are always two teams...
Q
Course Description: Despite a few guidance documents to help sponsors prepare...
Q
Course Description: If you go "off label" with advertising and...
Q
Course Description: Paying an employee is not simply multiplying the hourly...
Q
Course Description: This course will provide employees with pertinent...
Q
Course Description: The course will give the participant the ability to...
Q
Course Description: This two day course will prepare firms for a quick,...
Q
Course Description: Unlike risk management, which involves managing potential...
Q
Login to comment