Who should attend
This drug regulatory affairs course provides training on drug registration and regulation in Latin American – LATAM countries. The course covers the Drug Regulatory requirements across Latin America including Columbia, Peru, Brazil, Mexico, Argentina, Uruguay, Paraguay, Venezuela, Ecuador, Central America, Chile. The course provides training on marketing authorization filing in Latin American Countries.
LATAM DRA course covers recent regulations, marketing authorization procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover course focus on the regulatory affairs strategic planning for marketing authorization for different class of pharmaceutical, biopharmaceutical. Hence, this course is vastly useful for those who want to know or already working in regulatory affairs. Above all, this course will help them to enhance competency to handle LATAM pharmaceutical Marketing Authorization Application (MAA) effectively.
The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
Above all, the course is based on convenient online self paced learning. Hence, it provides flexibility to undergo training from any country across the globe. It also allows the user to stop and start at their leisure.
Course Title: Advance Certification in LATAM Drug Regulatory Affairs
Course Code: RYD-041
Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
This LATAM drug regulatory affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of in Latin American countries. Hence, this online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.
Key features of the course
- Orientation to practical understanding in the entire drug regulation, registration procedure of Latin American countries. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations. Above all, course explains various marketing authorization strategic pathways. Hence, this course helps to enhance the regulatory strategic decision making skill.
- The course extensively covers marketing authorization requirements for full application, verification pathway and abridged pathway.
- This training program has advance sessions on CMC preparation, Stability Study, Drug Master File Preparation, Site Master File Preparation, Good Manufacturing Practices modules. Above all, course focus on variation requirement specific to LATAM countries.
- The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
- Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
- Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.
Graduation in any discipline. Even the final year student can join the course.
Who should attend
- Course is ideal for the Freshers and beginners.
- Similarly, course provide advanced learning for those who want to know about the LATAM drug regulation and registration process.
- So, this course suits to those, who want to enhance knowledge about the LATAM Drug Regulatory Affairs.
- Certainly, LATAM Drug Regulatory Affairs course is ideal for Business Development, Regulatory Affairs, IPR, strategic management professionals. In short, course will provide 360 degree knowledge about the registration, regulation, strategic pathways of the pharmaceuticals in Latin American countries.
Certificate will be provided at the end of the successful completion of the course.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
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Latin America is generally understood to consist of the entire continent of South America in addition to Mexico, Central America, and the islands of the Caribbean.
North And Central America
Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, French Guiana (département of France), Guyana, Paraguay, Peru, Suriname, Uruguay, Venezuela.
Countries: Cuba, Dominican Republic, Haiti.
dependencies and constituent entities: Guadeloupe, Martinique, Puerto Rico, Saint-Barthélemy, Saint-Martin.
Learn more about the Latin American Countries >> Learn more
About regulatory affairs job>> Learn here
Regulatory Landscape – Latin America
Here are three important points to note.
- First of all, LATAM region does not have a centralized or harmonized procedure for drug registration. Hence, regulatory professionals need to learn each and every country regulation separately.
- However, adoption or adaptation of guidelines from ICH countries have helped to harmonize the requirements for the development and approval of new medicines.
- Thirdly, LATAM countries have been aligning regionally and reinforcing harmonization, through initiatives of the Pan American Health Organization (PAHO) via the Pan American Network for Drug Regulatory Harmonization (PANDRH).
Supranational key regulating bodies in Latin America
- PAHO/OPS – Pan American Health Organization.
- PANDRH/Red PARF – Pan American Network for Drug Regulatory Harmonization.
- WHO/OMS – World Health Organization.
- ICH – International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Global Cooperation Groups.