Date

What you'll learn

A broad audience of anyone in regulatory affairs who is dealing with lifecycle management and has been working with the previous variations guidelines.

By attending, you'll gain:

• Gaining a general appreciation of the new variation guidelines
• Understanding the principles of some of the key changes that have been introduced
• Practice strategies for managing the annual update variations
• Some of the impacts of the changes on UK IRP submissions
• Where to go to find further guidance
  
  

Who should attend

This webinar is ideal for Industry R&D and manufacturing professionals, regulatory affairs specialists, regulators, industry leaders, and academia.

Webinar host & presenters

		Host: Laura Hall MTOPRA Director, ESPL Regulatory Consulting Laura is a regulatory professional with nearly 15 years’ experience in EU and UK regulatory affairs across industry and consultancy. One of her key areas of focus is post-approval lifecycle management, where she supports complex change scenarios, variation classification, and compliant implementation strategies. Laura is already working with the new variations guidelines in practice and will share insights on their real-world application and challenges
		Presenter: Dr Helen Erwood FTOPRA Director, ESPL Regulatory Consulting Helen is a regulatory professional with more than 40 years experience in industry and consulting.  She has a broad expertise in regulatory submissions across multiple therapeutic areas, including extensive experience in lifecycle management.  Helen has already been working with the new variations guidelines – including managing some of the challenges that they bring.

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