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Regulatory Affairs in Latin America

PTI
Course summary
2 days
1,200 GBP excl. VAT
Online courses
Next available date: 25/08/2020 - Online courses
Professional Training

Course description

Regulatory Affairs in Latin America

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 

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

Course delivery details

In light of the uncertain times we’re facing at the moment, 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 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

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

Expenses

Book by 18/Aug/2020 to save £240.

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 2 reviews

Regulatory Submissions Manager, LEO Pharma
(5)
The trainer's attitude and knowledge was excellent.
Submissions Manager, LEO Pharma
(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.
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Reviews
Course rating
(5.0)
Based on 2 reviews
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