Enhance your understanding of pharma and biotech regulatory requirements to ensure compliance in the evolving Latin America region
Course Overview
The market opportunity in Latin America is growing considerably thanks to increased life expectancies which have prompted a rise in government spending on healthcare. Countries such as Brazil, Argentina, and Mexico are set to grow at a faster rate year on year than those in Europe, making the region a target for the (bio)pharmaceutical sector. With so many varying requirements and approval procedures across Latin America, navigating the regulations can be difficult and time-consuming.
This course will take you through the key regulatory requirements and procedures such as compiling the dossier, clinical trials, commercial landscape, and pharmacovigilance in each country so you have the skills and confidence to operate in the region. You will discover how to process pharmaceuticals including generics and biotech including biosimilars.
Countries discussed: Brazil | Mexico | Argentina | Colombia | Venezuela | Chile | Peru | Ecuador | Paraguay
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over 2 sessions students will learn through:
- Live interactive bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Regulatory authorities
Regulatory authorities
Explore the structure and function of key regulatory authorities
Registration procedures
Registration procedures
Examine registration processes including data requirements and dossier formats
Strategy
Strategy
Enhance registration strategies for pharmaceuticals and biotech, including generics and biosimilars
Key developments
Key developments
Learn how to manage regulatory developments in the region
Local regulations
Local regulations
Gain a critical overview of the healthcare system and local laws for pharmaceuticals
Key variances
Key variances
Explore the geographic, demographic and cultural differences in the area
Who is this course for?
Anyone working within the field of regulatory affairs at management level or above who want to gain an insight into the Regulatory landscape in Latin America, such as:
- Regulatory Affairs Specialist
- Regional Coordinator
- Regulatory Affairs Associate
- Development Pharmacist
- Pharmacovigiliance Manager
- Regulatory Affairs Attorney
- Regulatory Affairs Executive
- Project Managers
- Regulatory Affairs Manager
- Strategy Management
- Regulatory Affairs Officer
- Quality Manager
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.
