Introduction
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About RA
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.
Snapshot of the course
- Title of the course: Advance Certification in LATAM Drug Regulatory Affairs
- Course Code: RYD-041
- Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
- Course Duration: 1 Month
- Certification: Certificate will be provided at the end of the successful completion of the course.
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.
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.
- 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
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 21Introduction to Latam Pharma Market
Lecture 22Drug Registration and Regulation in Argentina
Lecture 23Drug Registration and Regulation in Bolivia
Lecture 24Drug Registration and Regulation in Brazil
Lecture 25Drug Registration and Regulation in CHILE
Lecture 26Drug Registration and Regulation in Colombia
Lecture 27Drug Registration and Regulation in Mexico
Lecture 28Drug Registration and Regulation in El Salvador
Lecture 29Drug regulation and registration in Peru
Lecture 30Honduras Drug Registration Guideline and Fact Files
Lecture 31RTCA - Central America Guideline Recent Update 2022
Lecture 32LATAM Country Clusters &Comparative Regulatory Logic | Wave Filing Strategy
Lecture 33Strategic Understanding on Delta Documentation
Lecture 34Marketing Authorization Framework Across LATAM
Lecture 35LATAM Dossier Structure Differences Matrix
Lecture 36Language Requirements for Latam Filing
Lecture 37ANVISA Regulatory Submission | Delta Packages | CMC | Stability Decision Tree | Case Study
Lecture 38Case Study - ANVISA Submission for generic pharmaceutical | Critical Steps | Pathways | Risk Analysis and Mitigation Strategy
Lecture 39COFEPRIS (Mexico) Regulatory Submission | NCE Pathways | NOM-177 Requirements
Lecture 40Stability Requirements for Pharmaceutical Products in Mexico (COFEPRIS)
Lecture 41LATAM Stability Requirement Comparison (Brazil vs Mexico vs Argentina vs Chile)
Lecture 42Global Stability Program Supporting LATAM Registrations
Lecture 43LATAM Review Test | Check your competency
Lecture 44LATAM Marketing Authorization Simulation
Section 3Plant Certification| Inspections | GMP requirements
Lecture 45Certification Pharmaceutical Companies / Plants
Lecture 46G1 Lecture Premises & Plant Layout Designing
Lecture 47G2 Lecture Sanitation and Hygiene
Lecture 48G3 Lecture Equipment Modules
Lecture 49G4 Lecture Production Modules
Lecture 50G5 Lecture Documentation
Lecture 51G6 Lecture Quality Control
Lecture 52G7 Lecture Product Complaint
Lecture 53G8 Lecture Storage Module
Lecture 54ISO and ISO Audits
Lecture 55Pharmaceutical SOPs Management from regulatory perspective
Lecture 56Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning
Lecture 57WHO-GMP Certification Scheme
Lecture 58Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 4Submission Dossier Preparation and Filing
Lecture 59Introduction to Common Technical Document (CTD)
Lecture 60Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 61Chemistry, Manufacturing & Controls
Lecture 62Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 63ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 64ICH Q2 : Analytical Validation
Lecture 65ICH Q3 : Impurities
Lecture 66Rest of ICH Q Family Guidelines
Lecture 67CMC Dossier & Compliance Management
Lecture 68Introduction to Electronic Common Technical Document (ECTD)
Lecture 69Key Consideration for Drug Master File Preparation and Submission
Lecture 70Practical Understanding on Drug Master File Preparation and Submission
Lecture 71Associated Learning: Site Master File - Detailed Understanding
Lecture 72Drug Master File - Global Perspective [Across Different Regions]
Lecture 73Importance of effective dossier management
Lecture 74Discussion on 85 common deficiencies in CTD submission dossier
Section 5Stability Study
Lecture 75Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 76Climate Zone
Lecture 77Stability Zone Finder
Lecture 78Stability Studies - Case Based Discussion
Lecture 79Stability Data for Zone IV countries
Lecture 80Accelerated and intermediate testing conditions
Lecture 81Long Term Stability Testing Requirements
Lecture 82Stability Study Protocol Development - Dosage form: Capsule
Lecture 83Stability Data Sheet
Lecture 84Stability Testing for dossier submission
Lecture 85Testing Frequency
Lecture 86Bracketing
Lecture 87Matrixing
Section 6PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 88PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 89Bioequivalence Study | Study design | Different types of BE Studies
Lecture 90Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning | Analyte | Bioanalytical Methods Validation | Statistical Model | Ln Transformation | Dose normalisation | Confidence interval acceptance criteria
Lecture 91Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 92Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 93Bioequivalence Study - Discussion - Dissolution Testing
Lecture 94Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 7Variation Management
Lecture 95Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 96Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 8Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 97Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 98Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 99Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 100Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 101RTQs | Response to Queries | How to handle Regulatory Queries
Section 9Final Certification - Request for Course Certification
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