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 Marriott Boston, MA
Wednesday, Nov 12, 2014 | Thursday, Nov 13, 2014
San Francisco, CA
Thursday, January 29, 2015 | Friday, January 30, 2015
Thursday, March 26, 2015 | Friday, March 27, 2015
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 Marriott Boston - Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
November 12-13, 2014
Special Offer for the attendees of this seminar:
Rooms available at only $239 per night.
Call 617-492-7777 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.
San Francisco, CA(Venue to be announced shortly)
January 29-30, 2015
Boston, MA(Venue to be announced shortly)
March 26-27, 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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Cambridge, MA, Local Attractions
San Francisco, CA, Local Attractions
Harvard Museum of Natural History
The Harvard Museum of Natural History, located on the grounds of Harvard University, displays a sampling of specimens drawn from the collections of the university's three natural history research museums: the Harvard University Herbaria, the Museum of Comparative Zoology, and the Harvard Mineralogical Museum. The museum is physically connected to the Peabody Museum of Archaeology and Ethnology and one admission grants visitors access to both museums. In the museum’s permanent galleries, visitors encounter the diversity of life on earth, from dinosaurs to fossil invertebrates and reptiles, to large mammals, birds and fish, and the only mounted Kronosaurus. The mineralogical galleries present a systematic display of meteorites, minerals and gemstones. The galleries also house the historic Blaschka glass models of plants, popularly known as the Glass Flowers and a new exhibition, Sea Creatures in Glass, displaying some of Harvard Museum of Comparative Zoology's collection of Blaschka models of marine invertebrates. In addition, a series of changing exhibitions bring focus to new research at the university.
Longfellow House–Washington's Headquarters National Historic Site
The Longfellow House–Washington's Headquarters National Historic Site, also known as the Vassall-Craigie-Longfellow House, was the home of noted American poet Henry Wadsworth Longfellow for almost 50 years. On July 16, 1775, George Washington occupied the abandoned house as his first official headquarters. Henry Wadsworth Longfellow became its owner in 1843 and lived there until his death in 1882. The home, which represents the mid-Georgian architectural style, is seasonally open to the public. On display are many of the original nineteenth century furnishings, artwork, over 10,000 books owned by Longfellow, and the dining table around which many important visitors gathered. The site also possesses some 750,000 original documents relevant to the former occupants of the home. These archives are open to scholarly research by appointment.
Fresh Pond is a reservoir and park in Cambridge, Massachusetts. Prior to the pond's use exclusively as a reservoir, its ice had been harvested by Boston's "Ice King", Frederic Tudor, and others, for shipment to North American cities and to tropical areas around the world. Fresh Pond Reservation consists of a 155 acre kettle hole lake, and 162 acres of surrounding land with a 2.25 mile perimeter road popular with walkers, runners and cyclists, and a nine-hole golf course.
The Brattle Theatre is a repertory movie theater located in Harvard Square in Cambridge, Massachusetts. The theatre is a small movie house with one screen. It is one of the few remaining movie theaters, if not the only one, that use a rear-projection system; the projector is located behind the screen rather than behind the audience. The Brattle Theatre mainly screens a mixture of foreign, independent, and classic films, and began showing repertory and foreign films in February 1953. Despite the rapid disappearance of American art house theaters, the Brattle has managed to maintain a loyal base of moviegoers while remaining independently operated.
Fogg Art Museum
The Fogg Museum is the oldest of Harvard University's art museums. It is renowned for its holdings of Western paintings, sculpture, decorative arts, photographs, prints, and drawings from the Middle Ages to the present. Particular strengths include Italian Renaissance, British Pre-Raphaelite, and French art of the 19th century, as well as 19th and 20th century American paintings and drawings. The museum's Maurice Wertheim Collection is a notable group of impressionist and post-impressionist works that contains many famous masterpieces, including paintings and sculptures by Paul Cézanne, Edgar Degas, Édouard Manet, Henri Matisse, Pablo Picasso, and Vincent van Gogh. Central to the Fogg's holdings is the Grenville L. Winthrop Collection, with more than 4,000 works of art including important 19thcentury paintings, sculpture, and drawings by William Blake, Edward Burne-Jones, Jacques-Louis David, Honoré Daumier, Winslow Homer, Jean Auguste Dominique Ingres, Pierre-Auguste Renoir, Auguste Rodin, John Singer Sargent, Henri de Toulouse-Lautrec, and James Abbott McNeill Whistler.
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity