
Introduction
Course Type
Course Duration
Feature
Eligibility
Who should attend
Certification
Course Deliverable
Related Courses
About RA
This pharmaceutical regulatory affairs course “Brazil Pharmaceutical Regulatory Affairs” provides training on marketing authorization process in Brazil. The course provide detail training on marketing authorization Procedure in Brazil. It 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 in Brazil. Hence, this course is vastly useful for those who want to know or already working in RA. This course will help them to enhance competency to handle Brazil 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.
The course can be completed at any place, allowing the user to stop and start at their leisure.
Course Code: RYD-068
Course Title:Â Advance Certification in Brazil Pharmaceutical Regulatory Affairs
Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
1 Month
This Brazil Pharmaceutical Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the Brazil pharmaceutical market. 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 Brazil. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations. Moreover, course explains various marketing authorization strategic pathways. This 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.
- 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.
- Freshers and beginners. Those who want to know about the Brazil Pharmaceutical Market, Regulation.
- Drug regulatory affairs professionals. Who want to enhance knowledge about the Brazil regulatory affairs.
- Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in Brazil.
 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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Insight on Brazil Pharmaceutical Market
A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Therefore, regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.
Brazil is the largest, and one of the most developed economies in the Latin America (LATAM). Hence, Brazil pharmaceutical market presents significant growth opportunities for local and multinational drug makers. In fact Brazil is one of the most attractive and promising pharmaceutical markets in the world. Therefore, you will find all major global pharmaceutical companies operating in the country. Above all, you will be finding mostly all multi national companies are having the head office in Brazil to cater entire LATAM region.
As we discussed, there are lot of regulatory changes as far as the the drug registration and regulation in Brazil in recent time. Therefore, our aim is to understand the recent resolution on pharmaceutical marketing authorization process in Brazil.
In this Brazil drug regulatory affairs course, focus is on learning the fundamental to advance learning regarding drug discovery, development to commercialization process. Secondly, course is designed to provide comprehensive training on marketing authorization process for pharmaeutical, biopharmaceutical. Above all, course provide extensive training on drug authorization dossier preparation. In addition, course provide access to case simulations and case studies pertaining to drug registration in Brazil. Certainly, this help all students to acquire practical understanding regarding marketing authorization process in Brazil.
About regulatory affairs job>> Learn here