One-Day Virtual Seminar

Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina)

BY: Robert J. Russell, President and CEO, RJR Consulting, Inc.

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

June 1, 2021
(11:00 AM to 5:00 PM EDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register
  • Testimonials

The Latin America Regulatory compliance requirement training/seminar 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 country establishment and successful product licensing.

Why You Should 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:
  • 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.
June 1, 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.
Robert J. Russell
Robert J. Russell, President of RJR Consulting, Inc

Bob is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products.

For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry.

Register Now

Online using Credit card

$1,099.00

(One Dial-in One Attendee)

June 1, 2021, Virtual Seminar
(Registrations till April 30, 2021 - $1099)
(Registrations after April 30, 2021 - $1299)

$5,625.00

Group-Max. 10 Attendees

June 1, 2021, Virtual Seminar
(Registrations till April 30, 2021 - $5625)
(Registrations after April 30, 2021 - $7795)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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By registering and attending FDATrainingAlert conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by FDATrainingAlert for marketing, archiving or any other conference related activities. You agree to release FDATrainingAlert for any kind of claims arising out of copyright or privacy violations.

See What People Say About Us

Regulatory landscape for pharmaceuticals in Brazil and Mexico topic was most valuable. Overall it was good seminar. It gave me a comprehensive view on the ins and outs of registration in LA. I like the scale of the event that makes it very focused and interactive.

Head Clinical Pharmacology and Bioanalytics

The speaker was excellent and knowledgeable with topic. Understanding the regulatory process and registration requirements topics were useful to me.

Associate Director

The presenter was very knowledgeable and interaction between participants and presenter was good.

International Regulatory Affairs Associate

The subject matter was very well presented and design of the presentation was appropriate.

Manager of Quality Assurance & Regulatory Affairs

The presenter was very knowledgeable. Medical device registrations and export/import topic was most valuable to me.

International Regulatory Program Manager

The presenter was very knowledgeable. The questions were answered quickly. Medical device topic was very informative.

RA Specialist III

Bob was a great instructor, very helpful. Thanks to ComplianceOnline.com for conducting this seminar, Medical Device companies always need to be compliant so guidance/updates are always needed. I would recommend ComplianceOnline.com to others. Thanks!

Manager

This seminar had great overview and introduction to Japan & S. Korea regulatory and clinical environment. Medical Device related material was most valuable for me as it is most aligned with my work. The amount of interaction between the participants and presenter was ideal. I would like to attend future seminar on "Regulatory and Clinical for Latin American countries".

Director of Global Product Safety

Understanding the regulatory structure in the countries and how they interact, was the most valuable topic for me. Overall it was a good seminar - I learned a lot. Enjoyed the informal nature and being able to ask questions as went along. I would like to give thanks to ComplianceOnline for good customer service on the phone.

Clinical Project Manager

Overall it was a good course for Japan/S. Korea familiarity. More content on device, more discussion using application of data in real life scenarios, and less straight reading slides. I would like to attend future conferences on "Medical Device Tech Files" and "Medical Device Directives & Essential Requirements".

Regulatory Affairs Specialist

ComplianceOnline website was helpful and informative for the conference. I like the areas covered on "Identification of regional differences, and regulations & processes". subject was well chosen and overall it was good experience.

Sr. Director

This course was offered by ComplianceOnline and it was excellent. Bob is very knowledgeable and have answered all my questions. I like the knowledge delivered on Clinical, however, got a lot more on other topics as well. Good Summary. I would like to attend future seminars on China and Latin America.

Sr. Director of Regulatory Affairs

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