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 country 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.

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
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October 6th, 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.
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Robert J. Russell

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

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.

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Register Now

Online using Credit card

$1,199.00

(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)
Last Recorded Date: October 6, 2021

$6,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)
Last Recorded Date: October 6, 2021



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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.

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Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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    • Testimonials

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    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,

    Abbott Healthcare Products B.V

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

    Associate Director,

    Purdue Pharmaceuticals

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

    International Regulatory Affairs Associate,

    Bard Access Systems, Inc.

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

    Manager of Quality Assurance & Regulatory Affairs,

    Keystone Industries, Inc.

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

    International Regulatory Program Manager,

    Asuragen, Inc.

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

    RA Specialist III,

    Moog Inc.

    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!

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    Clinical Operations, Clovis Oncology

    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,

    Kimberly-Clark Corporation

    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,

    Global Clinical Affairs, Kimberly-Clark Corporation

    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,

    I-Flow, LLC

    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,

    Gilead

    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,

    STAAR Surgical

    Instructor was very knowledgeable on topic. Length of the program was appropriate. I like the session of overall submission process. I would like to attend future seminars on China & Asia, and BRIC.

    Regulatory Affairs Specialist,

    I-Flow, LLC

    I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.

    Director of Regulatory Affairs,

    Nickell Physician & Pharmacy Services

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