top of page
WATERMARK ICON.jpg
image.png

​​

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.​

​

Who should attend?:

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

​

Date and time:

​

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.

​

 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.

​

Brief Workshop Agenda

Day 1: Introduction to Regulatory Affairs (3 hours)

  • Welcome and overview of regulatory affairs

  • Understanding frameworks, guidelines, and submission processes

​

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

​

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

​​​​

​

​

 

 

 

 

 

 

 

Dr. Hakima Ibrahim Hoseh, a certified Regulatory Affairs professional (RAC) with over 32 years of pharmaceutical industry experience, has held key roles at Hikma Pharmaceuticals and the JFDA, where she led regulatory committees and developed pivotal guidelines. An active consultant, author, and speaker on MENA regulations, she is recognized for her expertise in regulatory affairs and continuous professional development.

​

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

​

Fees: 

 

Registration and Payment

​​

image.png
bottom of page