This course is also available to attend in person.
When: 12-14 Jan 2027
Where: Online
Start time Day 1: TBC | End time Day 3: TBC
CPD: 19 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Professionals from the regulatory affairs industry who wish to develop their strategic planning
- Professionals from allied industries who wish to have a comprehensive understanding of the subject
What you'll learn
By completing this course, you will be able to:
- Demonstrate a systematic understanding 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.
Course overview
The course 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.
Course 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.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,750.00 + VAT* |
Standard Price
Non-member |
£2,450.00 + VAT* |
TOPRA MSc Students
|
£1,750.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to all attendees, regardless of your country of origin. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.
PLEASE ENSURE YOU SELECT THE PAY LATER OPTION AT CHECKOUT