The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful 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 course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Orphan Drugs and Combination Products in Latin America The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management and 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.
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
- Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
April 25, 2025 (9:00 AM to 12:00 PM PT)
Seminar Agenda
- Glossary of Terms.
- Defining the Opportunity: Overview of Latin America
- Country Facts: Argentina, Brazil, Mexico.
- Latin America's Regulatory Structure for the Life Science Product Industries
- Brazil – ANVISA Structure & Insight to Operations
- Mexico – COFEPRIS Structure & Insight to Operations
- Argentina – ANMAT Structure & Insight to Operations
- Mercosur - Southern Common Market
- Harmonization Efforts
- Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
- Registration / Required Country Licenses.
- Overview of the Rules Governing Medicinal Products & Medical Devices.
- Clinical Trials, GCP: When are they needed?
- GMP Compliance
- Stability Studies: Zonal Unique Requirements
- Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
- CTD Format Transition
- Summary of Product Characteristics
- Package Inserts
- Labeling Requirements
- Amendments / Variations / Renewals
- Marketing Authorization Processes
- Generic Products & Bioequivalence Testing
- Biologics & Biosimilars
- Orphan Drug Special Processes
- Compassionate Use / Special Access
- Medical Device Registrations & Product Licenses
- Device Classifications
- Amendments / Variations
- Device Renewal Applications
- Drug / Device Master File (DMF): Use in Latin America
- Processing Variations on Licensed Products.
- Labeling & Packaging Leaflet Requirements
- Drug / Device Vigilance & Post-Marketing Responsibilities
- Import / Export Procedures
- Patents / Copyrights / Trademarks
- Advertising & Promotion of Products
- How and When to Influence the Regulatory Process.
- The Regulatory Negotiation Process.
- How to Use Regulations / Regulatory Contacts to Your Advantage.
- Conclusions

Robert J. Russell
President and CEO, RJR Consulting, Inc
Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.
Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
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Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to customercare@complianceonline.com
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ComplianceOnline (MetricStream, Inc),
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San Jose, CA 95002
USA
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Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
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Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).Cancellations and substitutions for In-person Seminars:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Offers:Testimonials
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