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Compliance and Regulatory Affairs

Legal & Compliance Skills

Compliance and Regulatory Affairs

Legal & Compliance Skills

Compliance and Regulatory Affairs

  • Program Status
    Program Status:
    To be Launched Soon
  • Certification:
    Yes
  • Mode
    Mode:
    Videos + Live Sessions
  • Duration
    Duration:
    10 Videos / 1 hour each
  • Online Sessions
    Online Sessions:
    2 (1 hour each)
  • Efforts:
    3-4 hours / week
  • Classes
    Classes:
    Self-Paced
  • Assignments:
    Yes
  • Quizzes:
    Yes

About Program

Program Overview:

The Compliance and Regulatory Affairs Certificate Program is meticulously designed to provide participants with the essential legal and compliance skills needed to navigate the intricate regulatory environment in industries such as pharmaceuticals, medical devices, and global trade. The program includes 10 comprehensive topics covered through pre-recorded videos, each lasting 1 hour. Additionally, participants will benefit from 2 hours of live doubt clearing and mentorship sessions, providing an interactive and supportive learning experience.

The comprehensive curriculum of the Compliance and Regulatory Affairs Certificate Program aims to equip participants with the necessary knowledge and skills to navigate regulatory complexities, ensure compliance, and contribute to the effective management of regulatory affairs within their respective industries

Benefits

- Gain an in-depth understanding of regulatory frameworks and compliance requirements.

- Develop practical skills for risk management and ethical decision-making.

- Enhance career prospects by acquiring valuable knowledge in compliance and regulatory affairs.

- Access to industry-relevant insights and best practices from experienced professionals.

Curriculum

Video 1: Fundamentals of Regulatory Affairs

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.

Video 2: Regulatory Requirements for Pharmaceutical Products

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.

Video 3: Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices

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.

Video 4: Post-Approval Compliance Requirements for Pharmaceutical 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.

Video 5: Drug Safety and Pharmacovigilance

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.

Video 6: Medical Device Quality Systems

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.

Video 7: Medical Device Marketing

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.

Video 8: Overview of Global Regulatory Affairs

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.

Video 9: Medical Device Life-Cycle Management

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.

Video 10: Export Controls and Sanctions Compliance

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.

Live Doubt Clearing and Mentorship Sessions:

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.

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  • Online Sessions
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$2 500.00

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