When: 30 June - 2 July 2021
Where: Online 
Day 1 start time: TBC | Day 3 end time: TBC 

Course overview

The module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the management of global regulatory operations and strategic planning. It will cover:

• Strategic regulatory options for planning global drug development programmes 
• Interactions between industry and regulatory agencies
• Electronic Submissions (eCTD) - Strategic Implications,  electronic data standards and impact for global roll-out
• Regulatory Intelligence and the implications for drug development
• Strategic aspects on orphan drug development
• Paediatric drug development - strategic considerations and regulatory strategies
• Life-cycle management - regulatory issues and strategies
• Aspects of project management and strategic planning of the regulatory activities for global drug development programmes
• The module will also provide training in approaches to anticipate regulatory problems and analyse complex regulatory situations

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge of strategic planning.

This was an excellent introduction to the topic of regulatory strategy. I wish I had taken it years ago.”  – 2018 delegate

Benefits to delegates

This course will enable you to:

• Demonstrate a systematic understanding of knowledge, and a critical awareness of the theory and practice of global strategic planning strategies as they relate to obtaining regulatory marketing authorisation and pricing negotiations
• Display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes
• Demonstrate an in depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes
• Critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development
• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of drug development
• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.

Programme

Module Leader

• Christine Degeling - Associate Director, CMC Regulatory Affairs, MSD (The Netherlands)

Presenters 

TOPRA Masterclasses are developed and delivered by a faculty  of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

Connie van Oers - Sanofi-Genzyme
Mohamed Oubihi - Yakumed
Elliott SImonian - Independent Consultant
Marga Oortgiesen - UCB
Liesbeth  Hof -ProPharma Group
Matthew Pazdernik - Organon
Alessandro Lazdins - GSK
Ineke Jonker-Hoogerkamp - Eagle Pharma
Hayden Holmes - York Health Economics
Maaike van Dartel - CBG-MEB
Sjaak Bot- Janssen

Suitable for

• Students of the TOPRA MSc programme
• Delegates from the regulatory affairs industry who wish to develop their strategic planning
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing

Standard

• TOPRA MSc students: £1500+VAT*
• Delegates: £1700+VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

• Those working for regulatory agencies, government agencies or academic institutions: £1275+VAT
• Those working for charities, patient groups or in full-time education: £1275+VAT

*VAT, if applicable, is charged at the rate of 20%.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.