Latin America – Understanding Regulatory Compliance Requirements across the Life Science Industry

Date: Dec 02-03,2014  Location: San Francisco 

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.

Course Description:

The Latin America Regulatory Compliance requirement Training/Seminar will cover topics across the full Life-Cycle_of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skilful 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.

Why should you attend?

• This 2 day course will specifically focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America.
• Primary countries covered include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will also be discussed.
• The course will also cover topics relating to full product life-cycle_management, as well as, address 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.

This Program May Benefit the Following 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, Global Business Development personnel
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.

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Thank you & Regards,

Kevin Roberts,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com