If you are an American life science company doing business in Latin America, you must now the regulatory compliance requirements and procedures in the region. Especially, you must be aware how Latin America interacts and utilizes ICH standards—and how they relate with other regulatory agencies.
Join this webinar by expert speaker Robert J. Russell to get a better understanding of life science industry regulatory compliance in Latin America. This session will cover topics across the entire lifecycle of licensing a company or product(s) in key markets of the region. Robert will demonstrate whether written regulations or skillful negotiation can help you in every critical topic. You will understand the importance of local resources and agency meetings. Additionally, you’ll know how to navigate the regulatory landscape and accelerate country establishment and product licensing.
The session focuses especially on the overall compliance procedures and requirements dealing with Medical Devices, Biologics, Pharmaceuticals, Orphan Drugs, Biosimilar and combination products in the Latin American market (especially, Argentina, Mexico and Brazil). You will learn in details about full product life-cycle management, and know the regulatory agency structures in Latin America. You will get the description of methods used by regulators when they fill processes and register with corresponding agencies, and understand what is to be expected in authorization and dossier maintenance of licensed products.
Know the current regulatory climate in Latin American and get several examples which will illustrate effective compliance techniques and procedures. The presentation highlights common issues that have caused difficulties for Life Sciences firms in the region. Learn how Latin America utilizes and interacts with ICH standards, and understand how they are related with other national regulatory agencies. Also, the session will explain how personnel can address conflicts better.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.