Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
Instructor:
Robert J Russell
Product ID: 702038
- Duration: 90 Min
Why Should You Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, 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, 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.
Areas Covered in the Webinar:
- 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.
- Common Fees
- 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.
- Recent Country Legislation: New Regulations
- Conclusions
- Resources / Helpful Websites.
Who Will Benefit:
- 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.
Robert J Russell
President, RJR Consulting, Inc
For the past 9 years, Robert J. Russell 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.
More Training By Experts
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- Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I
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- Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
