Course description
Regulatory Affairs in Latin America
The market opportunity inLatinAmericais 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 acrossLatinAmerica, 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.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
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
Training Course Content
- Explore the structure and function of key regulatory authorities
- Examine registration processes including data requirements and dossier formats
- Enhance registration strategies for pharmaceuticals and biotech, including generics and biosimilars
- Learn how to manage regulatory developments in the region
- Gain a critical overview of the healthcare system and local laws for pharmaceuticals
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
The overview of Latin America was great. I actually took this course to learn more about the registration process in Mexico specifically. Good course content overall.
The trainer's attitude and knowledge was excellent.