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.
Why You Should 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 the wide array of licensed products.
Seminar Fee Includes:
- AM-PM Tea/Coffee
- Seminar Material
- USB with seminar presentation
- Hard copy of presentation
- Attendance Certificate
- $100 Gift Cert for next seminar
- Download Brochure
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.
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Understanding the Regulatory ProcessRegulatory Overview (gov't offices, organization, contact info)
- Brazil ANVISA
- Mexico – COFEPRIS
- Argentina – ANMAT
- Clinical Trials
- Clinical Trial Start-up
- Clinical Trial Application
- Marketing Authorizations/Registrations
- Registration requirements
- Registration documentation/CTD
- Summary of Product Characteristics
- Package insert
Day Two (8:30 AM – 4:30 PM)
Generics & Bioequivalence
- Medical Devices
- Device Classification
- Testing Standards
- Cost build-up model
Comparing & Contrasting LA and US
Challenges in Latin America
Influencing the Regulatory Process
Conclusions & summary
Robert J. Russell,
RJR Consulting, Inc.
Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.
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
- Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization
Courtyard New Orleans
910 Iberville Street
New Orleans, LA
General Driving Directions:Driving directions from Louis Armstrong New Orleans International Airport – MSY (15.4 miles E):
- Head northwest 0.1 mi. Continue straight onto Airport Rd.
- Turn left onto US-61 S/Airline Dr.
- Take the I-10 E ramp to US-90 BUS/Westbank.
- Keep left at the fork and merge onto I-10 E.
- Slight right to stay on I-10 E (signs for Slidell).
- Take exit 235A to merge onto Basin St/Orleans Ave toward Vieux Carre.
- Continue to follow Basin St.
- Turn left onto Conti St.
- Turn right onto N Rampart St then left onto Iberville St. Destination will be on the right.
Other Transportation:Bus Station
- Greyhound bus station in Central Business District 1 miles NW
- Amtrak Station Central Business District 1 miles NW