San Francisco Professional Events List


Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)


Date
Nov 28, 2018 - 08:30 AM
Organizer
NY Events List
Venue
San Diego
Location
San Diego, CA, San Diego,

San Diego,
California,
US,
ZIP: 92108
Phone:

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

 

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY!

 

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.


Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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

 

AGENDA

Day 01(8:30 AM - 4:30 PM)

  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
    • LA Overview
    • LA markets
    • Harmonization efforts
    • Understanding the Regulatory Process
    • Regulatory Overview (gov't offices, organization, contact info)
      • Brazil - ANVISA
      • Mexico – COFEPRIS
      • Argentina – ANMAT
    • Country Establishment
    • Clinical Trials
      • Clinical Trial Start-up
      • Clinical Trial Application
      • IND's
      • Reporting
      • GCP
    • Scientific advice
    • Stability studies
    • Pharmaceuticals
      • Marketing Authorizations/Registrations
      • Registration requirements
      • Registration documentation/CTD
      • Summary of Product Characteristics
      • Package insert
      • Labeling
      • Pharmacovigilance/Post-marketing
      • Amendments/Variations/Changes/Renewals
      • Fees
    • Submission Process
    • Paper filings
    • Electronic filings


Day 02(8:30 AM - 4:30 PM)
  •  
    • Generics & Bioequivalence
    • Biologics
    • Compassionate use
    • Orphan drugs
    • Medical Devices
      • Device Classification
      • Testing Standards
      • Registrations
      • Amendments/Variations/Renewals
      • Cost build-up model
      • Fees
      • Post-marketing
    • Combination products
    • Patents/Copyrights/Trademarks
    • Import/Export procedures
    • Tax exemptions
    • Advertising/Promotion
    • Comparing & Contrasting LA and US
    • Challenges in Latin America
    • Influencing the Regulatory Process
    • Conclusions & summary
 

SPEAKER

 

Robert J. Russell
Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.

 

Please contact the event manager Marilyn ([email protected] ) below for:

- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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Event Categories
Keywords: fun, business , class , climate, Clinical , development , environment, Fun , Health , HealthCare




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