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, PA
Thursday, August 27, 2015 | Friday, August 28, 2015
Thursday, November 12, 2015 | Friday, November 13, 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 Philadelphia Downtown
21 N. Juniper Street,
Philadelphia, PA, USA, 19107
August 27-28, 2015
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Call 1 (800) 321-2211 or (215) 496-3200 on or before Wednesday,July 29, 2015 and identify as Compliance Online.
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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!
- 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
Deerfield, IL, 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.
Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.
Deerfield Golf and Learning Center
Open to the public, Deerfield Golf Club is a beautiful 18-hole championship golf course, with a learning center, practice ranges, clubhouse and more. If you would like to tune up your game, lessons are available with PGA and golf professionals. Deerfield Golf Club and Learning Center boasts one of the finest 18-hole golf courses in the entire Chicago area. Designed by famed golf course designer Edward Lawrence Packard, the course measures nearly 7,000 yards from the championship tees; however, the course offers five sets of tees that will challenge the expert yet afford the beginning golfer a very playable and pleasurable experience.
Chicago Botanic Garden
A mere 15 minute drive from Deerfield, the Chicago Botanic Garden is situated in Glencoe, Illinois. It is a 385-acre living plant museum that features 26 display gardens and is surrounded by four natural habitats: McDonald Woods, Dixon Prairie, Skokie River Corridor, and Lakes and Shores. The garden is open every day of the year.
Brushwood Center at Ryerson Woods
The Brushwood Center holds that environmental education extends beyond childhood and science to embrace human interaction with nature and its expression, including literature, music, photography, film and other fine and performing arts. Using the natural sanctuary of Ryerson Woods as a springboard for education, the Brushwood Center explores the interplay of art and nature with various activities year round.
Kohl Children’s Museum
Kohl Children’s Museum of Greater Chicago is located on an 8.8-acre parcel of land in the center of The Glen in Glenview, at 2100 Patriot Boulevard, Glenview, Illinois. The museum boasts of 23,000 square feet of public space. An additional 2-acre outdoor exhibit space, Habitat Park, allows for museum attendance to be less weather-dependent. Kohl Children’s Museum houses 17 hands-on, interactive exhibits. The museum has developed a Parents’ Guide to Kohl Children's Museum of Greater Chicago to help parents and children choose the exhibits they want to visit.
The Cuneo Mansion and Gardens is a historic home, art collection and gardens in Vernon Hills, Illinois, near Deerfield. Built in 1914, the mansion now hosts an art gallery as well. It opened its doors to the public for the first time in 1991. The mansion's paintings, tapestries, and other furnishings are the lifelong collections of the Cuneo family, the mansion’s last owners. In addition to architecture and art, Cuneo is also known for its grounds. During the holiday season, the museum and its grounds are decorated with holiday lights and people are invited to drive through a "Winter Wonderland Light Show". Interpretive tours of the mansion and its collections are conducted by museum guides and staff. The Mediterranean style mansion features an arcaded central hall, a lavish formal dining room and a private chapel. The collections include antique furnishings, Renaissance paintings, tapestries, silver and porcelain.
Lambs Farm is a non-profit organization in Libertyville, Illinois, about 20 minutes from Deerfield. It provides vocational and residential services for over 250 adults with developmental disabilities. Located on a 72-acre campus, Lambs Farm includes several family attractions, including a petting zoo, a pet shop, a miniature golf course, several small amusement rides, a restaurant, a thrift shop, a country store and a bakery. Since its inception in the 1960s, Lambs Farm has come a long way and now hosts thousands of visitors each year, making it the third most popular attraction in Lake County, Illinois.
Less than 30 minutes away Deerfield, in Tempel Farms Wadsworth, you can visit the rare and graceful white Lipizzan stallion. During the summer months, this world renowned breed of horse performs in the traditional style upheld by Vienna’s prominent Spanish Riding School. Visitors are awed as the horses are taken through a series of classical movements and jumps.