Skip Main Navigation
Page Content

Save This Event

Event Saved

Latin America- Regulatory Compliance Requirements for Life Science Products across the Life Science Industry [Brazil, Mexico, Argentina, Colombia, and Chile]:2-day In-person Seminar

Compliance.world

Wednesday, February 22, 2017 at 10:00 AM - Thursday, February 23, 2017 at 5:00 PM (PST)

Latin America- Regulatory Compliance Requirements for...

Ticket Information

No tickets available.

Who's Going

Loading your connections...

Share Latin America- Regulatory Compliance Requirements for Life Science Products across the Life Science Industry [Brazil, Mexico, Argentina, Colombia, and Chile]:2-day In-person Seminar

Event Details

Location: San Diego
Dates: 22 -23 Feb 2017
Duration: 2Days

Speaker:Robert J. Russell, FDA

 

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.

Course Description:

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.

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.

 

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


COURSE AGENDA:

Day 1: 8:30 am – 4:30 pm

Registration: 8:30 – 9:00 am

Session Start Time: 9:00 am to 12 Noon

  • Glossary of Terms.
  • Defining the Opportunity: Overview of Latin America
  • Country Facts: Brazil, Mexico, Argentina, Colombia and Chile
  • 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
  • Colombia – INVIMA Structure & Insight to Operations
  • Chile – ISP 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?

Lunch Break: 12 Noon to 1 pm

Session Start Time: 1 pm to 4:30 pm

  • GMP Compliance
  • Stability Studies: Zone Unique Requirements
  • Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
  • CTD Format Transition
  • Summary of Product Characteristics
  • Use of Expert Reports
  • Package Inserts
  • Labeling Requirements
  • Amendments / Variations / Renewals
  • Fees
  • Daily Recap & Review of Upcoming Day 2 Agenda

Day 2:  8:30 – 4:30 pm

  • Medical Device Registrations & Product Licenses
  • Device Classifications
  • Test Standards & Certifications
  • Amendments / Variations
  • Device Renewal Applications
  • Drug / Device Master File (DMF): Use in Latin America
  • Processing Variations on Licensed Products.
    • Variations: Changes to Marketed Products.
    • Types of Variations.
    • Dossier Maintenance Expectations.
    • Changes Concerning Manufacturing Aspects (Product & Process)….

Lunch Break: 12 Noon to 1 pm

Session Start Time: 1 pm to 4:30 pm

  • Labeling & Packaging Leaflet Requirements: Day 2 Products
  • Drug / Device Vigilance & Post-Marketing Responsibilities
  • Marketing Authorization Processes
    • Generic Products & Bioequivalence Testing
    • Biologics & Biosimilars
    • Orphan Drug Special Processes
    •  Compassionate Use / Special Access
  • Labeling & Packaging Leaflet Requirements: Day 2 Products
  • Drug / Device Vigilance & Post-Marketing Responsibilities
  • Import / Export Procedures
  • Patents / Copyrights / Trademarks
  • Advertising & Promotion of Products
  • Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.
    • Comparison of Processes.
    • Agency Interactions
  • The Regulatory Negotiation Process.
    • Effective Approaches.
    • The Do's and Don'ts of Regulatory Involvement.
  • How to Use Regulations / Regulatory Contacts to Your Advantage.
    • Agency Interactions.
    • Professionalism in Regulatory Lobbying.
  • Conclusions

 

  Please Click here to Enroll & for more details

Regards,

Joshua

Training Manager

Email: joshua@compliance.world

Call us at : 1-732-7225220

Website: compliance.world

Have questions about Latin America- Regulatory Compliance Requirements for Life Science Products across the Life Science Industry [Brazil, Mexico, Argentina, Colombia, and Chile]:2-day In-person Seminar? Contact Compliance.world

Save This Event

Event Saved

When & Where


San Francisco

San Francisco, CA

Wednesday, February 22, 2017 at 10:00 AM - Thursday, February 23, 2017 at 5:00 PM (PST)


  Add to my calendar

Organizer

Compliance.world

Compliance.world is established to impart high quality training on governance, regulations and compliance (GRC) through webinars and seminars. We are passionate about processes, procedures, safety and regulations across industries. We value an individual’s right to obtain high quality services and products without discrimination or difference. We understand the importance of compliance to established standards, practices and regulatory frameworks. We encourage professionals, officers and executives from government, industry and Non-governmental organizations to become aware of regulatory frameworks and guidelines. Training them in implementation of these rules and regulations is the best way to encourage and ensure universal compliance. High quality trainings, facilitated by industry experts with decades of experience is our way of contributing towards this cause and we take pride in delivering experience-rich sessions.

  Contact the Organizer
Latin America- Regulatory Compliance Requirements for Life Science Products across the Life Science Industry [Brazil, Mexico, Argentina, Colombia, and Chile]:2-day In-person Seminar
Things to do in San Francisco, CA Class Family & Education

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.