Virtual Classroom Training
Brazilian Regulatory Environment – an Overview on CMC and Module 3 Requirements for Synthetic Medicines

Bespoke interactive e-learning

Gain a deeper understanding of the specific regulatory requirements and challenges in Brazil to ensure that your products comply with ANVISA regulations.

The key learnings of this training are:

  • Understand the regulatory environment in Brazil
  • Understand the regulatory requirements for registering a drug in Brazil, focusing on Module 3

Date: June 4 - 11th, 2024

Type: Virtual Classroom Training

Duration: 1 day (afternoons only)

Who should attend?: Pharmacists, chemists, project managers, technicians and R&D staff working on drugs for the Brazilian market.

Price on demand

Program

PART 1 :

  • Introduction to ANVISA and its role in regulating medicine products in Brazil
  • Prior considerations before registering Medicines in Brazil
  • Licensing and market authorization
  • Good Manufacturing Practices (GMP)
  • Brazilian CMC requirements for Medicine Products
  • Preparation and submission of technical dossier
  • Fees and timelines for registration

PART 2 :

  • Complex regulatory requirements and procedures
  • Key Requirements
  • Lengthy review process
  • Overview on safety and efficacy modules
  • Main Reasons for Refusals and Objection Letters (CMC aspects)
  • Strict post-market surveillance requirements
  • Common challenges and solutions in the Brazilian regulatory environment

Fatima MONTEIRO

Pharmacist and Regulatory Affairs Manager. She has over 13 years’ experience in the pharmaceutical industry, working in the regulatory department, particularly in research and development, obtaining marketing authorizations in Brazil and several Latin American countries. She has in-depth knowledge of Latin American health regulations, in particular ANVISA. She also has consolidated experience in the registration and post-approval modification of drugs in various categories (new molecules, similar drugs, generics, herbal products, specific products, biologics and others).

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