One-Day Virtual Seminar on Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

Robert J. Russell
Oct 6 - Oct 6 , 2021
Starting at

$999


Oct 6 - Oct 6 , 2021
Buy Now

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings, and knowing how to navigate the regulatory landscape will accelerate the country's establishment and successful product licensing.

Why Should You Attend:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs, 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 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.

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.

October 6, 2021 (11:00 AM to 5:00 PM EDT)

Seminar Agenda

  • 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.
Seminar (Price/Register)
Oct 6 - Oct 6 , 2021

Single Registration


Group-Max. 10 Attendees


Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
  1. Download the Order Form
  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

Payment Mode

By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

  Media Partners

If you wish to partner with us for this event

please contact us: partner or
call us: 1-866-978-0800

Media Partner Benefits

  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do

  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

  Sponsors

If you wish to partner with us for this event

please contact us: sponsor@compliance.world or
call us: 1-866-978-0800
Speaker: Robert J. Russell,

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.


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