Anvisa Regulatory Affairs Course

Lesson 1 • Key Regulatory Instruments

Introduces resolutions, normative instructions, and technical notes as binding instruments. Distinguishes mandatory rules from guidance documents used in practice.

Lesson 2 • Anvisa's Mandate and Structure

Covers Anvisa's legal origin, mission, and organisational hierarchy. Provides context for all subsequent regulatory interactions and submissions.

Lesson 3 • Regulatory Risk and Compliance Culture

Introduces risk-based thinking and compliance culture as foundational professional mindsets. Sets expectations for ethical conduct throughout the course.

Lesson 4 • Stakeholder Ecosystem

Identifies industry, healthcare providers, civil society, and international bodies interacting with Anvisa. Clarifies each stakeholder's role in shaping and complying with regulations.

Lesson 1 • Review Timelines and Prioritisation

Explains standard, priority, and expedited review tracks and their eligibility criteria. Selecting the correct track optimises time-to-market planning.

Lesson 2 • Electronic Submission Systems

Guides use of Anvisa's digital platforms for filing and tracking submissions. Proficiency reduces technical rejections and accelerates processing.

Lesson 3 • Dossier Structure and Requirements

Details the administrative, technical, and safety sections of a registration dossier. Proper structure is essential for acceptance and timely review.

Lesson 4 • Responding to Technical Queries

Prepares professionals to draft compliant responses to agency requests for additional information. Effective responses prevent rejection and maintain review momentum.

Lesson 1 • Process Validation and Quality Control

Addresses validation of manufacturing processes and in-process quality controls. Validated processes are mandatory evidence in registration dossiers.

Lesson 2 • GMP Principles and Legal Basis

Establishes the scientific and legal foundations of GMP as applied by Anvisa. Connects GMP requirements to product safety and registration validity.

Lesson 3 • Facility and Equipment Requirements

Covers physical plant design, equipment qualification, and environmental controls required by Anvisa. Non-compliant facilities trigger inspection findings and registration holds.

Lesson 4 • Documentation and Record Management

Defines GMP documentation standards including SOPs, batch records, and deviation reports. Accurate records are the primary evidence reviewed during inspections.

Lesson 1 • Pharmacovigilance System Requirements

Defines the mandatory components of a pharmacovigilance system under Anvisa rules. A functional system is required for registration maintenance and renewal.

Lesson 2 • Post-Market Studies and Commitments

Addresses post-registration study commitments imposed by Anvisa as approval conditions. Fulfilling commitments on schedule protects registration status.

Lesson 3 • Safety-Driven Regulatory Actions

Covers label updates, market withdrawals, and recalls triggered by safety signals. Professionals must execute these actions within Anvisa-mandated timeframes.

Lesson 4 • Risk Management Plans

Explains when risk management plans are required and how to structure them for Anvisa review. Plans must address identified and potential risks with proportionate measures.

Lesson 1 • Conformity Assessment and Certification

Covers conformity assessment routes and the role of accredited bodies in device certification. Certification documents are mandatory dossier components for higher-risk devices.

Lesson 2 • Device Classification System

Explains Anvisa's risk-based device classification and its impact on registration requirements. Correct classification determines the applicable technical dossier standard.

Lesson 3 • Device Post-Market Surveillance

Establishes post-market surveillance obligations specific to medical devices, including vigilance reporting. Surveillance data feeds back into risk management and label updates.

Lesson 4 • In Vitro Diagnostic Devices

Addresses the distinct regulatory pathway for in vitro diagnostic devices under Anvisa rules. IVD-specific performance evaluation and labelling requirements differ from general devices.

Lesson 1 • Food Labelling Requirements

Covers mandatory nutritional, allergen, and origin labelling rules for food products. Accurate labels are a prerequisite for market authorisation and consumer safety.

Lesson 2 • Food Safety Regulatory Framework

Maps Anvisa's food safety standards, including additives, contaminants, and hygiene requirements. Compliance prevents product seizure and market withdrawal.

Lesson 3 • Cosmetic Product Notification

Explains the notification-based pathway for cosmetics and the technical file required. Notification must precede market launch and be maintained throughout product life.

Lesson 4 • Cosmetic Safety and Efficacy Claims

Addresses substantiation requirements for cosmetic claims and advertising restrictions. Unsubstantiated claims expose companies to enforcement actions.

Lesson 1 • Post-Approval Variations

Classifies changes to approved registrations and the notification or approval required for each. Unauthorised changes constitute a regulatory violation.

Lesson 2 • Labelling Updates and Management

Addresses the process for updating approved labelling, including safety-driven and commercial changes. Label version control is a GMP and regulatory requirement.

Lesson 3 • Registration Renewal Process

Covers renewal timelines, required documentation, and consequences of lapsed registrations. Timely renewal prevents involuntary market withdrawal.

Lesson 4 • Registration Cancellation and Withdrawal

Covers voluntary and involuntary registration cancellation and the obligations that follow. Proper cancellation prevents ongoing compliance liabilities.

Lesson 1 • Agency Interaction and Negotiation

Covers formal and informal mechanisms for engaging Anvisa, including pre-submission meetings. Effective agency interaction resolves ambiguity and builds productive relationships.

Lesson 2 • Regulatory Intelligence Systems

Builds systems for monitoring Anvisa publications, consultations, and enforcement trends. Proactive intelligence prevents compliance gaps and informs product strategy.

Lesson 3 • Regulatory Strategy Development

Applies regulatory knowledge to build product-specific strategies aligned with business timelines. Strategic planning reduces time-to-market and resource waste.

Lesson 4 • Cross-Functional Regulatory Leadership

Positions regulatory affairs as a strategic partner to R&D, marketing, and supply chain. Integrated leadership prevents late-stage regulatory surprises.