Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar
Robert J. Russell, President of RJR Consulting, Inc.
Courtyard Boston Cambridge, MA
Thursday, March 26, 2015 | Friday, March 27, 2015
New Orleans, LA
Thursday, May 21, 2015 | Friday, May 22, 2015
Thursday, August 27, 2015 | Friday, August 28, 2015
||Course "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
|Day One (8:30 AM – 4:30 PM)
||Day Two (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
- Scientific advice
- Stability studies
- Marketing Authorizations/Registrations
- Registration requirements
- Registration documentation/CTD
- Summary of Product Characteristics
- Package insert
- Submission Process
- Paper filings
- Electronic filings
- Generics & Bioequivalence
- Compassionate use
- Orphan drugs
- Medical Devices
- Device Classification
- Testing Standards
- Cost build-up model
- Combination products
- Import/Export procedures
- Tax exemptions
- Comparing & Contrasting LA and US
- Challenges in Latin America
- Influencing the Regulatory Process
- Conclusions & summary
Meet Your Instructor
||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.
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Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
March 26-27, 2015
Special Offer for the attendees of this seminar:
Rooms available at only $199 per night.
Call 866-323-4159 and identify yourself as part of the ComplianceOnline group
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
From Boston Logan International Airport – BOS: 7.3 mile(s) W
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
- Continue straight and cross bridge
- Take first right after bridge onto Memorial Drive
- Hotel is 200 yards ahead on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
- Follow I-293 to I-93S towards Boston
- Take exit 26B (Storrow Drive West) and continue for 3 miles
- Bear right at the Central Square/MassPike exit and turn right at the light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- Take I95N to I93N
- Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
- Take the Central Square/MassPike exit and turn right at light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- Back Bay Station (BBY): 3 mile(s) SE
- South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.
New Orleans, LA (Venue to be announced shortly)
May 21-22, 2015
Philadelphia, PA (Venue to be announced shortly)
August 27-28, 2015
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!
- 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 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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Boston, MA, Local Attractions
New Orleans, LA, Local Attractions
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
Welcome to the birthplace of jazz, New Orleans. Every night of the week, the streets and clubs of the Big Easy are still alive with vibrant music. From traditional jazz to acid jazz, there's something for every ear, every day of the week.
With over 45 museums throughout the city to choose from, it's easy to immerse yourself in the city's history, culture and arts.
One block over from the raucousness of Bourbon Street is the French Quarter’s more refined and elegant epicenter of local artistic culture. Royal Street is an eye-pleasing mix of classy antique shops and boutiques, fine jewelry stores, colorful art galleries and world-class hotels and restaurants.
French Quarter Attractions
There’s a reason so many visitors flock to the French Quarter every day – both locals and tourists can’t get enough of the unique area’s unique attractions. From the beautiful architecture to art galleries, museums, restaurants, and bars, the French Quarter has something for everyone – no matter what your interests, budget, or age may be. Join up with a tour and learn more about the fascinating history of the area, or spend the entire day exploring and shopping in the area, topping everything off with an excellent meal in a world-famous restaurant and some live music. With so much culture, history, and entertainment, you’ll find a unique and exciting experience around every corner.
Although this historic French Quarter street has a bawdy reputation due to the burlesque clubs and all-night partying, come experience a whole other side of Bourbon Street steeped in history, folk lore and beauty that dates back to 1718 when New Orleans was founded by Jean-Baptiste Le Moyne de Bienville. Also known as “Rue Bourbon,” this historic street sits at the heart of the French Quarter extending 13 blocks from Canal St. to Esplanade Avenue.