This Latin America regulatory compliance requirements training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
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 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 licensed products.
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
Instructor Profile:
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.
Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.
Note:
Use coupon code NB5SQH8N and get 10% off on registration.
For Registration:
http://www.complianceonline.com/latin-america-regulatory-compliance-requirements-across-life-science-industry-webinar-training-702038-prdw?channel=sciencedz