InstructorRoyed Training
TypeOnline Course
Price$490 USD / 24500 INR.
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Latam drug regulatory affairs


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Latam Drug Regulatory Affairs

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.

1 Month

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.

  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

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

Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama.

South America

Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, French Guiana (département of France), Guyana, Paraguay, Peru, Suriname, Uruguay, Venezuela.

Caribbean countries

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.

Section 1Fundamental Understanding on Drug Discovery and Development
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8USFDA expedited programs
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Orphan Drug Designation 
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Lecture 15Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 16Clinical Trials Terminologies 
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 20Review on Drug Discovery and Development 
Section 2Latam Regulatory Requirements and Strategic Planning for Marketing Authorization Application
Lecture 21Different Business Regions
Lecture 22Introduction to Latam Pharma Market
Lecture 23Drug Registration and Regulation in Argentina 
Lecture 24Drug Registration and Regulation in Bolivia
Lecture 25Drug Registration and Regulation in Brazil 
Lecture 26Drug Registration and Regulation in CHILE
Lecture 27Drug Registration and Regulation in Colombia
Lecture 28Drug Registration and Regulation in Mexico
Lecture 29Drug Registration and Regulation in Peru
Lecture 30Drug Registration and Regulation in Uruguay
Lecture 31Drug Registration and Regulation in Paraguay
Lecture 32Drug Registration and Regulation in Venezuela
Lecture 33Drug Registration and Regulation in Ecuador
Lecture 34Drug Registration and Regulation in Belize
Lecture 35Drug Registration and Regulation in Costa Rica
Lecture 36Drug Registration and Regulation in El Salvador
Lecture 37Drug Registration and Regulation in Guatemala
Lecture 38Drug Registration and Regulation in Honduras
Lecture 39Drug Registration and Regulation in Nicaragua
Section 3Plant Certification| Inspections | GMP requirements
Lecture 40Certification Pharmaceutical Companies / Plants
Lecture 41G1 Lecture Premises & Plant Layout Designing
Lecture 42G2 Lecture Sanitation and Hygiene
Lecture 43G3 Lecture Equipment Modules
Lecture 44G4 Lecture Production Modules
Lecture 45G5 Lecture Documentation
Lecture 46G6 Lecture Quality Control
Lecture 47G7 Lecture Product Complaint
Lecture 48G8 Lecture Storage Module
Lecture 49ISO and ISO Audits
Lecture 50Pharmaceutical SOPs Management from regulatory perspective
Section 4Submission Dossier Preparation and Filing
Lecture 51Introduction to Common Technical Document (CTD)
Lecture 52Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 53CMC Dossier & Compliance Management
Lecture 54Drug Master File
Lecture 55Site Master File
Lecture 56Practical Training on preparing DMF and SMF
Lecture 57Comparison of various regulatory bodies with Latam
Section 5Stability Study
Lecture 58Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 59Climate Zone
Lecture 60Stability Zone Finder
Lecture 61Stability Studies - Case Based Discussion
Lecture 62Stability Data for Zone IV countries
Lecture 63Accelerated and intermediate testing conditions
Lecture 64Long Term Stability Testing Requirements
Lecture 65Stability Study Protocol Development - Dosage form: Capsule
Lecture 66Stability Data Sheet
Lecture 67Stability Testing for dossier submission
Lecture 68Testing Frequency
Lecture 69Bracketing
Lecture 70Matrixing