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
Miami, FL| Wednesday, September 17, 2014 | Thursday, September 18, 2014
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:
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:
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
Miami, FL(Venue to be announced shortly)
TestimonialsWhat past attendees say
Presenter was very knowledgeable. A good number of participants were there and it was a highly interactive seminar.
This seminar was very informative especially the topics related to Brazil. Speaker was very knowledgeable on this topic.
It was a great seminar and I found it extremely informative. Interaction among participants was really great.
Seminar was quite interesting especially in terms of good networking and sharing personal experiences.
This seminar was really useful and it did provide some good insight on drugs and biologics compliance process for BRIC.
This seminar was good and it was good to get an understanding of medical device registration because I work in Regulatory Affairs.
It did provide very useful information about Russia and China Life Science products compliance processes.
Presenter was very knowledgeable. Topic Biologics import to these countries were really useful as this is related to my current job profile.
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.
South Beach is the most popular tourist attractions in Miami Florida located at east of Miami city, proper between Biscayne Bay and the Atlantic Ocean. The beach is the ideal place for a breath of fresh air beach style. It is perfect place for sunbathing, shopping or just watching people passing by on the beach.When the sun sets on South Beach, daytime shoppers become nighttime club-hoppers at a diverse array of nightspots.
It is a 38-acre (15 ha) oceanarium (oldest in the US) located on the island of Virginia Key in Biscayne Bay. In addition to marine mammals, it houses fish, sharks, sea turtles, birds, reptiles, and manatees. The park offers daily presentations and hosts overnight camps, events for boy scouts, and group programs.
Zoo Miami is the largest and oldest zoological garden in Florida, and the only tropical zoo in the United States. It houses over 2,000 animals on 740 acres (299 ha), 324 acres (131 ha) of which are developed.
Miami Science Museum
The Miami Science Museum is a great learning place. The museum itself also contains the Space-Transit Planetarium, Weintraub Observatory and a wildlife center. Those interested in galaxies, stars, planets and the intricate workings of the universe can quench their thirst for knowledge here.
Coral Castle is a stone structure created by the Latvian American eccentric Edward Leedskalnin (1887-1951 in Miami-Dade County at the intersection of South Dixie Highway (U.S. 1) and SW 157th Avenue. The structure comprises numerous megalithic stones (mostly limestone formed from coral), each weighing several tons. It currently serves as a privately-operated tourist attraction. Coral Castle is noted for legends surrounding its creation that claim it was built single-handedly by Leedskalnin using magnetism and/or supernatural abilities.
Oleta River State Park
The Oleta River State Park is a 1,043-acre (4.22 km2) Florida State Park on Biscayne Bay. Although it offers a variety of recreation, it is best known for its miles of off-road bicycling trails, ranging from novice trails to more than 10 miles challenging trails for experienced mountain bikers.
Jungle Island (formerly Parrot Jungle) is an interactive zoological park in Watson Island, Miami. It offers visitors a fun, educational opportunity to get an up-close look at tropical birds in replicas of their natural habitats. The attraction routinely hosts field trips and offers frequent educational programs. Jungle Island is home to animal wonders like Hercules, a 900-pound liger and Peanut and Pumpkin, our twin orangutans.
No visit to Miami is complete without a stop at the historical 50-acre Vizcaya estate. This European-style mansion offers a glimpse at life in turn-of-the-century South Florida. It's also an extremely popular venue for galas, weddings and other entertainment events.
We need below information to serve you better