Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar

By: Robert J. Russell, President of RJR Consulting, Inc.
Location :- Tampa, FL | Thursday, March 21, 2019 | Friday, March 22, 2019

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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 Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • 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 Two (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

Meet Your Instructor

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.

Venue

Location :
Tampa, FL (Venue to be announced shortly)

March 21-22, 2019
Register Online

Register Online

$1,299

Seminar One Registration

March 21-22, 2019, Tampa, FL
(Registrations till December 10, 2018 - $1299)
(Registrations after December 10, 2018 - $1699)

Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee lunch and afternoon tea/coffee on both days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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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)

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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 GRC Seminars event and a credit note will be issued.

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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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Testimonials

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 GRC Seminars.com for conducting this seminar, Medical Device companies always need to be compliant so guidance/updates are always needed. I would recommend GRC Seminars.com to others. Thanks!
- Manager, 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 GRC Seminars 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.

GRC Seminars 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 GRC Seminars 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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Salvador Dali Museum
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Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work.



Craftsman House
Craftsman House is a gallery that showcases contemporary art works. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.

Busch Gardens
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.