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Regulatory Affairs Course: Frameworks, Strategies, and Hands-On Applications.  

 

 

 

A short description of the workshop

This CPD-accredited 3-day workshop provides a deep understanding of regulatory frameworks, submissions, and best practices. You will explore advanced strategies, manage submissions efficiently, and apply knowledge through workshops and case studies.​

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Who should attend?:

​Professionals involved in regulatory affairs, compliance, and product development across industries such as pharmaceuticals, medical devices, biotechnology, and healthcare.​

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Date and time:

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Objectives:​

• Interpret regulatory frameworks locally and globally.

• Understand pathways for market approvals.

• Ensure compliance with Good Regulatory Practices.

• Strategize for multi-country submissions.

• Solve challenges through case studies.

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 Course Benefits: 

• Navigate evolving local and global regulations.

• Learn strategies for multi-country approvals.

• Apply best practices for regulatory compliance.

• Engage in live interactive online sessions.

• Earn 8 CPD-accredited hours.

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Brief Workshop Agenda

Day 1: Introduction to Regulatory Affairs (3 hours)

• Welcome and overview of regulatory affairs

• Understanding frameworks, guidelines, and submission processes

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Day 2: Advanced Topics in Regulatory Affairs (3 hours)

• Good Regulatory Practice for compliance and risk management

• Strategies for multi-country submissions

• Future trends in regulatory affairs

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Day 3: Hands-On Applications (2 hours)

• Practical workshop on preparing submissions

• Case studies and group activities on multi-submissions

• Simulation exercise on Good Regulatory Practice

• Q&A, feedback, and course wrap-up

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Certificates with CPD-accredited hours will be issued to participants upon completion of the course.​

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Fees: 

 

Registration and Payment

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