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Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry
This Latin America regulatory compliance requirements training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
Why Should You 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 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 Seminar:
- Glossary of Terms.
- Defining the Opportunity.
- Country Facts: Argentina, Brazil, Mexico.
- Latin America's Regulatory Structure for the Life Science Product Industries
- Mercosur - Southern Common Market.
- 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.
- Select Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.
- Marketing Authorization Processes - Filings & Registrations.
- Drug vs. Medical Device vs. Biologic vs. Combination Product.
- Drug Master File (DMF) Use in Latin America Registrations.
- Use of Expert Reports.
- Processing Variations on Licensed Products.
- Variations: Changes to Marketed Products.
- Types of Variations.
- Dossier Maintenance Expectations.
- Changes Concerning Manufacturing Aspects (Product & Process).
- Labeling & Packaging Leaflet Requirements.
- Orphan Drugs / Rare Diseases.
- Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
- Comparison of Processes.
- Agency Interactions.
- Accepted Practices.
- How and When to Influence the Regulatory Process.
- Accepted Country Practices.
- Effective Monitoring Activity.
- Association vs. Individual Company Involvement & Intervention.
- The Regulatory Negotiation Process.
- Effective Approaches.
- The Do's and Don'ts of Regulatory Involvement.
- How to Use Regulations / Regulatory Contacts to Your Advantage.
- Check-in Procedure.
- Agency Interactions.
- Business Impact Within and Outside Latin America.
- Professionalism in Regulatory Lobbying.
- Resources / Helpful Websites.
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
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.
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.
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Robert J Russell
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