Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
Robert J. Russell 2012 - Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
Topics/Call fo Papers
Agenda: (All time in EST)
1:00 ? 2:15 pm Course Delivery
2:15 ? 2:30 pm Q&A Session
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.
o 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.
o 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.
o Variations: Changes to Marketed Products.
o Types of Variations.
o Dossier Maintenance Expectations.
o 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.
o Comparison of Processes.
o Agency Interactions.
o Accepted Practices.
? How and When to Influence the Regulatory Process.
o Accepted Country Practices.
o Effective Monitoring Activity.
o Association vs. Individual Company Involvement & Intervention.
? The Regulatory Negotiation Process.
o Effective Approaches.
o The Do's and Don'ts of Regulatory Involvement.
? How to Use Regulations / Regulatory Contacts to Your Advantage.
o Check-in Procedure.
o Agency Interactions.
o Business Impact Within and Outside Latin America.
o Professionalism in Regulatory Lobbying.
? Resources / Helpful Websites
Who Will Benefit:
This course will be beneficial to:
? Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment
? Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
? 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
https://compliance2go.com/index.php?option=com_tra...
1:00 ? 2:15 pm Course Delivery
2:15 ? 2:30 pm Q&A Session
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.
o 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.
o 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.
o Variations: Changes to Marketed Products.
o Types of Variations.
o Dossier Maintenance Expectations.
o 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.
o Comparison of Processes.
o Agency Interactions.
o Accepted Practices.
? How and When to Influence the Regulatory Process.
o Accepted Country Practices.
o Effective Monitoring Activity.
o Association vs. Individual Company Involvement & Intervention.
? The Regulatory Negotiation Process.
o Effective Approaches.
o The Do's and Don'ts of Regulatory Involvement.
? How to Use Regulations / Regulatory Contacts to Your Advantage.
o Check-in Procedure.
o Agency Interactions.
o Business Impact Within and Outside Latin America.
o Professionalism in Regulatory Lobbying.
? Resources / Helpful Websites
Who Will Benefit:
This course will be beneficial to:
? Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment
? Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
? 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
https://compliance2go.com/index.php?option=com_tra...
Other CFPs
- Avoid the common confusion surrounding Corrections and CAPA
- The Investigator Agreement: How and When to Complete FDA Form 1572
- What the FDA looks for in SOPs during an inspection
- Educating for Peace and Harmony with the Earth and Ourselves
- Document Approval, Control, and Distribution: How to Develop a Compliant, Cost Effective System
Last modified: 2012-02-14 20:59:23