Overview
This topic provides a foundational understanding of regulatory affairs, including the interpretation and application of regulations throughout the product lifecycle.

Relevance
Essential for professionals entering the field of regulatory affairs, this topic covers the fundamental principles and practices necessary to comprehend and navigate regulatory requirements in various industries.

Overview
This topic delves into the specific regulatory requirements governing pharmaceutical products, including submissions, compliance, and strategies for pre-market and post-market phases.

Relevance
Crucial for individuals working in the pharmaceutical industry, this topic offers insights into the unique regulatory landscape of pharmaceutical products and their compliance requirements.

Overview
This topic provides an introduction to regulatory affairs and compliance, focusing on the specific considerations for drugs, biologics, and medical devices.

Relevance
Pertinent for professionals in the pharmaceutical and medical device industries, this topic addresses the specialized regulatory expectations and compliance requirements for these products.

Overview
This topic covers the post-approval compliance requirements specific to pharmaceutical products, including ongoing regulatory obligations and best practices.

Relevance
Essential for professionals involved in post-approval activities, this topic addresses the critical compliance aspects following the approval of pharmaceutical products.

Overview
This topic explores the principles and practices of drug safety and pharmacovigilance, emphasizing the regulatory considerations and processes involved.

Relevance
Relevant for professionals in pharmaceutical regulatory affairs, this topic focuses on the crucial aspect of ensuring the safety and monitoring of drugs in compliance with regulations.

Overview
This topic delves into the quality systems applicable to medical devices, covering regulatory expectations and best practices for ensuring quality compliance.

Relevance
Pertinent for individuals in the medical device industry, this topic addresses the specific quality system requirements and regulatory standards for medical devices.

Overview
This topic provides insights into the regulatory considerations and requirements related to the marketing of medical devices, including promotional strategies and compliance.

Relevance
Crucial for professionals involved in marketing medical devices, this topic covers the specific regulatory aspects governing the marketing of these products.

Overview
This topic offers an overview of global regulatory affairs, highlighting the regulatory landscape in major international markets and the implications for compliance.

Relevance
Important for professionals operating in global markets, this topic addresses the diverse regulatory requirements and considerations for products on an international scale.

Overview
This topic focuses on the life-cycle management of medical devices, encompassing regulatory aspects, compliance requirements, and best practices.

Relevance
Pertinent for professionals involved in the life-cycle management of medical devices, this topic covers the regulatory considerations throughout the product life cycle.

Overview
This topic provides an in-depth understanding of export controls, sanctions compliance, and their implications, including the relevant laws and regulatory frameworks.

Relevance
Essential for individuals dealing with global trade, this topic addresses the legal and compliance aspects of export controls and sanctions, providing insights into the regulatory environment.

The program includes two 1-hour live sessions dedicated to doubt clearing and mentorship, providing participants with the opportunity to interact with industry experts, seek clarification on course content, and gain valuable insights into practical applications and real-world scenarios.