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 Philadelphia Downtown
Thursday, August 14, 2014 | Friday, August 15, 2014
Monday, October 13, 2014 | Tuesday, October 14, 2014
Wednesday, Nov 12, 2014 | Thursday, Nov 13, 2014
||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 Philadelphia Downtown
21 N. Juniper Street
Philadelphia, PA 19107
August 14-15, 2014
How to Reach
General Driving Directions:
Driving Directions from Philadelphia International Airport – PHL: 10 mile(s) SE
- Take Interstate 95 North to Interstate 676 West
- Exit at Broad Street (Route 611)
- Stay in the left lane and take the first left turn onto Vine Street
- Continue on Vine Street to 12th Street and turn right
- Proceed to Market Street and turn right
- Follow Market Street toward City Hall and the hotel will be on the right immediately after the first traffic light.
- Greyhound Bus Lines: 0.3 mile(s) E
- 13 St Station: 0.1 mile(s) SE
- Blue Line: 0.1 mile(s) S
- Amtrak-PHL: 1.2 mile(s) W
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
Deerfield, IL(Venue to be announced shortly)
October 13-14, 2014
Seattle, WA(Venue to be announced shortly)
November 12-13, 2014
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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Philadelphia, PA, Local Attractions
Seattle, WA, Local Attractions
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
The Barnes Foundation
The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.
The Rocky Statue
One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.
Pike Place Market
Pike Place Market, Seattle's public market, is home to shops and stands selling farm produce, specialty foods, international groceries, handmade crafts, antiques and collectibles, books and clothing, along with 60 restaurants and take-out spots. Pike Place Market is also the home of the world's first Starbucks, which is located across the street from the main market building.
Built in 1962, the iconic Seattle Space Needle stands 605 feet (184 meters) tall. The most important thing atop the Seattle Space Needle is the view, a 360-degree panorama of the city, Puget Sound, Mount Rainier, the Cascade and Olympic mountain ranges.
Woodland Park Zoo
Spread over 65 acres, Woodland Park Zoo is one of the oldest zoos on the West Coast, home to the largest live animal collection in Washington state, with nearly 1,145 specimens representing 290 species. Over a million people visit the zoo each year, and it's no wonder. Woodland Park has won five major exhibit awards from the American Zoo and Aquarium Association
Located on Pier 59, the Seattle Aquarium features creatures from the Puget Sound area and other underwater places. Their collection includes a giant octopus, and their marine mammals include not just the obligatory sea otters and sea lions, but also fur seals
Seattle Pioneer Square
Seattle's oldest neighborhood is now a twenty-block historic district, its red brick buildings home to many of Seattle's art galleries, cafes and book stores. Sights and activities here include Underground Tour, Klondike Gold Rush Historic Park, Smith Tower and Seattle Police Museum. Pioneer Square comes alive after dark, when visitors and locals alike flock to its nightspots, sports bars and restaurants.
Seattle Art Museum
The Seattle Art Museum features contemporary art, Northwest coast Native American art, Old Masters and African masks, along with rotating exhibits of works from their 21,000-object Seattle Art Museum collection and frequent traveling exhibitions.
Sprawling across more than 500 acres in northern Seattle, Discovery Park is the city's largest green space — you'll find hiking trails, meadows, beaches and sand dunes abound.
There are many fun things to do and sights to see as you stroll up and down Seattle's Elliot Bay waterfront. It is a working waterfront, so watch out for traffic and trains as well as container ships and fishing boats. The Seattle Aquarium is the prime waterfront attraction, where you can see creatures that live above and below the waters of Puget Sound and the world. Other Seattle waterfront highlights include Ye Olde Curiosity Shop, the Cruise Ship Terminal, Bell Harbor Marina, and some great seafood restaurants.