On-demand Webcast: Brazil - Challenges with Drug Submissions

In this difficult economic time, companies must be able to diversify and look for new opportunities and target markets. Brazil is a growing country that, despite the financial crisis, continues to grow in a rapid pace. It is important to note that Brazil has the most complex regulations of any country in Latin America.

In this webcast, the speakers will highlight the current status of Brazilian regulatory processes for drug products and discuss how to develop a regulatory strategy using the Brazilian market scenario. The trends in regulatory and clinical requirements as well as marketing and regulatory strategy issues will also be discussed. Regulatory experts Marcela Saad and Adriana Serrão will share their experiences with attendees. This webcast will help attendees who are currently developing applications to submit to the Brazilian authorities as well as those who are planning to diversify themselves to emerging markets.

Learning Level(s): Basic to Intermediate

Learning Objectives:

Upon the webcast's conclusion, you should be able to: 

• Understand the primary dossier requirements in Brazil
• Classify a drug
• Explain the primary differences and main issues experienced when dealing with ANVISA

Who Should Attend:

• Regulatory professionals interested or involved with Brazilian regulatory issues
• Regulatory and business professionals working in and with companies involved in developing products for the Brazilian Market
•  Companies that are planning to establish their own business in Brazil
• Companies that are already in the Brazilian market and are having difficulties with Marketing Applications.

Speaker(s)

Marcela Saad, president & senior consultant, MarcM Consulting Canada

Marcela Saad is president & senior consultant of MarcM Consulting Canada. She has more than 20 years of extensive experience in international pharmaceutical regulatory affairs and business-government relations (covering areas of product registration, trademarks, patent evaluation, GMP compliance and training). Saad continues to participate in several national and international professional bodies and activities, has multiple language skills (English, Portuguese and Spanish) and augments her proven record of success both in company growth and profitability with a unique ability to create and maintain a winning environment. Saad works out of MarcM Consulting Canada's office in Kitchener, Ontario where she and the company primarily focus their expertise on improving trade within the Americas. An industrial pharmacist from Latin America, she holds an MSc in clinical pharmacology.

Adriana Serrão

Adriana Serrão is a pharmacist with 25 years of experience in pharmaceutical and healthcare industries. Serrão has worked on both multinational and Brazilian companies such as Alcon, Aché, Biosintetica, Teva, General Electric and Eurofarma. Her expertise covers quality and regulatory affairs areas, including Brazil and Latin America responsibilities. She has been leading regulatory affairs in different companies and successfully managed registration and other regulatory aspects of a number of products, including generic, biologic, medical devices, cosmetics, and dietary supplements.