InstructorRoyed Training
TypeOnline Course
Price$390 USD / 18500 INR.
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Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

Course Deliverable

Related Courses

About RA

Drug Registration and Regulation of Brazil

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: 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.

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Few of the similar courses

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

Section 1Fundamental Sessions
Lecture 1Understanding on Drug Discovery Development Process to Commercialization
Lecture 2Investigational New Drug and Investigational New Drug Application
Lecture 3Understanding on New Drug and New Drug Application
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Clinical Trial Phases - Regulatory Understanding
Section 2Brazil Marketing Authorization Process
Lecture 6Marketing Authorization Process | Product Types and classes | Submission Pathways | MA Variation | Renewals | Handling online submission process
Lecture 7Chemistry, Manufacturing & Controls 
Lecture 8Advance Understanding on Submission Dossier (Common Technical Document (CTD)
Lecture 9Advance Practical Training on Dossier Preparation focusing on drug registration in Saudi Arabia
Lecture 10CMC Dossier & Compliance Management
Lecture 11Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 12Documentation Required for Saudi Arabia | Comparing Documentation Required for Brazil (LATAM) against other regions
Lecture 13Key Consideration for Drug Master File Preparation and Submission 
Lecture 14Practical Training on preparing DMF and SMF
Lecture 15Site Master File
Lecture 16Importance of effective dossier management
Lecture 17Discussion on 85 common deficiency in CTD submission dossier
Section 3GMP Management and Plant Inspection Handling
Lecture 18Premises & Plant Layout Designing
Lecture 19Sanitation and Hygiene
Lecture 20Equipment
Lecture 21Production Module
Lecture 22Documentation
Lecture 23Quality Control
Lecture 24Handling of Product Complaint
Lecture 25Storage Module
Lecture 26Advance Training on Data Integrity | Principle of Data Integrity | How to manage data integrity issues
Section 4Certification Examination