Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations: 2-day In-person Seminar
Robert J. Russell, President of RJR Consulting, Inc
Courtyard Newark Downtown, NJ
Thursday, April 9, 2015 | Friday, April 10, 2015
Thursday, July 9, 2015 | Friday, July 10, 2015
||Course "Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets - Brazil, Russia, India and China.
Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense.
Structured healthcare systems and insurance coverage is now more prevalent among these emerging nation populations and predictions for growth of Rx and OTC products is impressive in these relatively untapped markets.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Brazil, Russia, India and China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators review filings and registrations and what is expected in the authorization and dossier maintenance of licensed products throughout their life.
Understanding cultural norms, establishing relationships and protecting your intellectual property will also be discussed and these will need to be integrated into your company training and corporate business strategies.
This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in these emerging markets. It will provide training on:
- The Nation's Regulatory Structure.
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- How to begin your company's involvement in each country (Brazil, Russia, India, China): local licenses, in-country personnel required and facilities required or contracted
- Clinical Trials: When are Clinical Trials needed? When are they not? Healthcare Authority requirements, the Application Process, Ethics Committee approval, CRO Selection and Start-up
- The current key regulations effecting product development and your company's product pipeline
- Product Licensing / or Registration; Licensing differences across Product Types
- Pricing establishment
- Healthcare Insurance systems and reimbursement
- Understanding the local concerns and specific challenges in working with each country's Regulatory Authority
- Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding each market to your company's global market presence
- Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package
- Strategies for streamlining the registration application process for faster approval
- Maintenance on Authorized Products
- License Renewals
- Import / export; Licenses and Supply Chain considerations
Who will Benefit:
This course will be beneficial to the following personnel whose responsibilities require knowledge of these Emerging Markets' regulatory requirements for Life Science products:
- Regulatory Affairs
- Supply Chain
- Import / Export
- Global Business Development
- General Management
- Administrative Staff
Topic Back Ground:
More than ever, the World has become one integrated market for conducting Global Clinical Research and for expanding the market for pharmaceuticals, biologics, medical devices and combination products. The time and expense of bringing new products to market continue to challenge budgets and existing balance sheets. While it is necessary to continue to have a robust pipeline of new patented products, global producers have been evaluating how best to begin participating in the emerging markets of Brazil, Russia, India and China. Manufacturers are looking to tap into the huge population areas of the World and bring innovative products to these patient populations. Taking products which already have existing country licenses and expanding these licenses into BRIC nations is proving to be an effective strategy for those who have begun.
The BRIC nations, as they are known (Brazil, Russia, India and China) have been improving the sophistication of their regulatory regime governing the food and Life Science products industry in recent years. This has included amending GMP ,GLP, GCP, GSP and other regulations allowing their country policies to further align with international standards of practice. This better alignment will assist the growth in these markets for new and already licensed products. For manufacturers and distributors of Life Science Products in these emerging markets, it is important to pay close attention to the pace at which their Healthcare Agencies implement these changes. Manufacturers and distributors must in turn add this knowledge and adjust their standard operating procedures when necessary to ensure compliance with the evolving regimes.
This course will be beneficial to Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Global Business Development and General Management personnel whose responsibilities require knowledge of these Emerging Market’s regulatory, quality and import / export requirements. Additionally, administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant. Global business development and general management requiring an understanding of how regulations and compliance issues must be followed in finding a local distributor / partner, setting up a company office or establishing local or contract manufacturing facility will profit from attending.
Meet Your Instructor
||Robert J. Russell
President of RJR Consulting, Inc
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.
Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.
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Courtyard Newark Downtown
858 Broad Street,
Newark, NJ 07102,USA
April 9-10, 2015
Special Offer for the attendees of this seminar:
Rooms available at only $159 per night.
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Driving Directions from Newark Liberty International Airport - EWR: 3.9 miles N
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- Newark Penn Station - 0.7 miles NE
- Newark Penn Station - 0.7 miles NE
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.
Atlanta, GA(Venue to be announced shortly)
July 9-10, 2015
What past attendees say
Presenter was very knowledgeable. A good number of participants were there and it was a highly interactive seminar.
- Sr. Dir. Legal Counsel, Boston Scientific
This seminar was very informative especially the topics related to Brazil. Speaker was very knowledgeable on this topic.
- Project Manager, Genentech
It was a great seminar and I found it extremely informative. Interaction among participants was really great.
- Vice President, Quality, Optimer Pharmaceuticals, Inc
Seminar was quite interesting especially in terms of good networking and sharing personal experiences.
- Regulatory Affairs, Bio-Rad Laboratories
This seminar was really useful and it did provide some good insight on drugs and biologics compliance process for BRIC.
- Specialist, Quality Assurance, International Quality, Amgen Inc
This seminar was good and it was good to get an understanding of medical device registration because I work in Regulatory Affairs.
- Reg. Affairs Associate, Bard Peripheral Vascular
It did provide very useful information about Russia and China Life Science products compliance processes.
- Reg. Affairs Associate, Bard Peripheral Vascular
Presenter was very knowledgeable. Topic Biologics import to these countries were really useful as this is related to my current job profile.
- QA, Baxter
Instructor was really good and he had given good examples related to the subject. Classroom participation was great. Cultural issues discussed were extremely helpful because these are the unwritten rules that have significant impact for product approval.
- Senior Quality Manager
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Newark, NJ, Local Attractions
Atlanta, GA, Local Attractions
The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.
Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.
Branch Brook Park:
Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.
Cathedral Basilica of the Sacred Heart, Newark, New Jersey:
The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.
Newark Symphony Hall:
Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.
Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.
John Ballantine House:
The John Ballantine House was the home of Jeannette Boyd (1838–1919) and John Holme Ballantine (1834–1895). John was the son of Peter Ballantine, founder of the Ballantine beer brewery, and became president of the family business in 1883 after his father died. The house was built in 1885 at 49 Washington Street in the Washington Park section of Newark, Essex County, New Jersey. It is now part of the Newark Museum and is open to the public for tours.
Centennial Olympic Park
Centennial Olympic Park is a 21 acre public park located in downtown Atlanta, Georgia owned and operated by the Georgia World Congress Center Authority. The park was built by the Atlanta Committee for the Olympic Games (ACOG) as part of the infrastructure improvements for the Centennial 1996 Summer Olympics. The park plays host to millions of visitors a year and several events, including a summer popular music concert series (Wednesday WindDown) and an annual Independence Day concert and fireworks display.
The Georgia Aquarium houses more than 100,000 animals, representing 500 species, all of which reside in 10 million US gallons of marine and fresh water. It was the world's largest aquarium when it opened in 2005. The aquarium's notable specimens include four young whale sharks, four beluga whales, eleven bottlenose dolphins, and four manta rays. It is the only institution outside Asia housing whale sharks, kept in a 6.3-million US gallon tank—the aquarium as a whole was designed around the whale shark exhibit. The facility also features 3D and 4D movies as part of their attractions.
High Museum of Art
The High Museum of Art (colloquially the High), located in Atlanta, is the leading art museum in the Southeastern United States. Located on Peachtree Street in Midtown, the city's arts district, the High is a division of the Woodruff Arts Center. In 2010, the museum recorded a landmark 509,000 visitors. It is also referred to as Louvre Atlanta thanks to its local popularity. The High Museum holds more than 14,000 works of art in its permanent collection. Included in this collection are 19th- and 20th-century American art; European art; decorative arts; and modern and contemporary art and photography. Highlights of the permanent collection include works by Giovanni Battista Tiepolo, Claude Monet, Martin Johnson Heade, Dorothea Lange, Clarence John Laughlin, and Chuck Close.
The zoo is one of four zoos in the U.S. currently housing giant pandas. Zoo Atlanta's Outback Station houses Australian wildlife, including red kangaroos, Major Mitchell's cockatoos and southern cassowary. This part of the zoo is a petting zoo and home to Saanen goats, Oberhasli goats, Southdown babydoll sheep, Gulf Coast sheep, Nigerian dwarf goats and a Kunekune pig. Other popular exhibits include the Ford African Rain Forest, Boundless Budgies: A Parakeet Adventure, Trader's Alley and Complex Carnivores, African Plains, Giant Pandas, Asian Forest and the World of Reptiles.
Fernbank Museum of Natural History
Fernbank Museum of Natural History presents exhibitions and programs about natural history that entertain as well as educate the public. Its mission is to encourage a greater appreciation of the planet and its people. Fernbank Museum has a number of permanent exhibitions and regularly hosts temporary exhibitions in its expansive facility. Giants of the Mesozoic, on display in the atrium of the museum, features a 123-foot (37 m) long Argentinosaurus (the largest dinosaur ever classified) as well as a Giganotosaurus. The permanent exhibition, A Walk Through Time in Georgia, tells the twofold story of Georgia's natural history and the development of the planet. Fernbank Museum has won several national and international awards for its newest permanent exhibition, Fernbank NatureQuest, an immersive, interactive exhibition for children.
Atlanta Botanical Garden
The Atlanta Botanical Garden is a 30-acre botanical garden located adjacent to Piedmont Park in Midtown Atlanta, Georgia. Incorporated in 1976, the garden's mission is to "develop and maintain plant collections for the purposes of display, education, conservation, research and enjoyment." In winter, the garden has a holiday light show featuring displays created with over 1.5 million lights. The Atlanta Botanical Garden is home to the Kendeda Canopy Walk, a 600-foot-long skywalk that allows the visitors to tour one of the city's last remaining urban forests ¬from around 40 feet in the air through the treetops of the Storza Woods. The skywalk extends from a bluff in the garden into the branches of oaks, hickories and poplars. The structure also provides an aerial view of the woodland garden below. In 2006, an exhibition of the sculpture of Niki de Saint Phalle opened to the public. These huge mosaic sculptures came to the garden from France, Germany, and California.
Atlanta Cyclorama and Civil War Museum
The Atlanta Cyclorama and Civil War Museum is a civil war museum in Atlanta, most noted for its attraction the Atlanta Cyclorama, a cylindrical panoramic painting of the Civil War Battle of Atlanta. The museum is located in historic Grant Park, adjacent to Zoo Atlanta. The museum displays a wide range of pictures and artifacts from the Civil War. The Atlanta Cyclorama, currently valued at $25 million, is one of the world’s largest painting that visitors view from the inside, after entering through an entrance in the floor. Once seated, the central cylinder rotates slowly, affording a view of the entire painting.