Course Structure

Week 1: Foundations of Global Regulatory Affairs

Class 1: Introduction to Regulatory Affairs

• Definition and evolution of regulatory affairs in the pharmaceutical industry.
• Overview of global regulatory authorities: FDA, EMA, MHRA, PMDA, and more.
• Regulatory frameworks in the USA and EU.

Class 2: Lifecycle of a Medicinal Product

• Overview of drug development stages: discovery, preclinical, clinical, and post-marketing.
• Key considerations for pediatric trials and orphan drugs.
• Importance of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Week 2: Preparing Submissions for Global Markets

Class 1: Common Technical Document (CTD) and Electronic CTD (eCTD)

• Structure and modules of the CTD: administrative, quality, nonclinical, and clinical information.
• Advantages of eCTD submissions and technical infrastructure requirements.
• Tools and strategies for eCTD creation, validation, and submission.

Class 2: Regulatory Submissions in the US and EU

• Investigational New Drug (IND) applications: structure, filing, and FDA review process.
• Clinical Trial Authorization (CTA) applications for the EU: EudraCT registration and IMPD requirements.
• Navigating the centralized, decentralized, and mutual recognition procedures in Europe.

Week 3: Specialized Regulatory Pathways

Class 1: Orphan Drug Applications

• Criteria and incentives for orphan drug designation in the US and EU.
• Application processes and sponsor obligations.
• Addressing challenges in rare disease drug development.

Class 2: Expedited Programs and Biosimilars

• Overview of FDA’s priority review, accelerated approval, and fast track designations.
• Regulatory pathways for biosimilars: Biologics Price Competition and Innovation Act, and Biosimilar User Fee Act.
• Understanding biosimilarity, interchangeability, and market exclusivity periods.

Week 4: Regulatory Compliance and Risk Management

Class 1: Post-Marketing Requirements and Pharmacovigilance

• Managing variations, supplements, and line extensions in the US and EU.
• Overview of pharmacovigilance requirements, safety reporting, and risk management plans (RMPs).
• Addressing GMP compliance and audit readiness for marketed products.

Class 2: Managing Regulatory Risks and Patent Challenges

• Handling patent certifications for ANDAs under the Hatch-Waxman Act.
• Navigating patent disputes and exclusivity issues.
• Strategies for responding to regulatory deficiencies and implementing corrective actions.

Week 5: Advanced Regulatory Topics

Class 1: Biologics and Monoclonal Antibodies

• Regulatory submissions for biologics and monoclonal antibodies in the US and EU.
• Understanding the Biologics License Application (BLA) process.
• Quality, nonclinical, and clinical considerations for monoclonal antibody approvals.

Class 2: Regulatory Strategies for Generics and 505(b)(2) Applications

• Overview of ANDAs: bioequivalence, patent certification, and Orange Book use.
• The 505(b)(2) pathway: leveraging published literature and existing data for drug approval.
• Addressing unique challenges in generic and hybrid product submissions.

Week 6: Leadership, Audits, and Career Preparation

Class 1: Preparing for Audits and Inspections

• Principles of GCP inspections and audits: purpose, scope, and outcomes.
• Preparing regulatory submissions and investigational sites for audits.
• Post-audit actions: addressing findings and implementing corrective action plans.

Class 2: Leadership Development and Career Advancement

• Developing leadership and communication skills for global regulatory roles.
• Resume building and interview preparation tailored for Regulatory Affairs Managers.
• Simulated interviews with expert feedback and real-world scenarios.

Program Highlights

• Interactive Learning: Hands-on case studies, exercises, and mock audits.
• Comprehensive Content: Covers regulatory submissions, compliance, and leadership skills.
• Career-Ready Skills: Prepares participants for strategic roles in global regulatory affairs.

Tangible Benefits:

• ✔ Career Readiness in 6 Weeks
• ✔ Resume and Interview Prep
• ✔ On-the-Job Support

Career Benefits:

• 🌍 100% Remote Work Opportunities
• 💼 Salary Potential: $160,000 - $275,000