Data for Abridged Applications and Specialised Products

Data for Abridged Applications and Specialised Products
Learn to consider and evaluate the practical regulatory aspects of regulatory strategy and data requirements for abridged applications (generics), specialised products (herbals, drug-device combination, radiopharmaceuticals, cosmetics, inhalation and blood products) and strategic issues of abridged US options.

When:19-21 May 2026
Where: TOPRA Office,3rd Floor, City Reach, Greenwich View Place, London, E14 9NN
Day 1 start time: 09:00 GMT | Day 3 end time: 17:00 GMT

This course is also available to take part in Online

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of abridged applications and specialised products
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


Course Information

This course is intended for those  who would like to learn more about abridged applications (generics) and specialised products and in the field of regulatory strategy and data requirements for herbals, inhalation products, drug/device combination, blood products, radiopharmaceuticals, cosmetics,  and students who are completing the TOPRA MSc in regulatory affairs. 

Attendees will expand their knowledge of dossier requirements for established molecules, namely drug substance and drug product CMC data, bioequivalence strategy, abridge applications, clinical and non-clinical considerations, strategic issues of herbals, inhalation products, drug/device combinations, blood products, radiopharmaceuticals cosmetics and the possibilities of abridged options in the US. 

All speakers on this course are very knowledgeable and covered a wide range of topics.”  – 2018 delegate

Benefits to delegates

Knowledge and understanding:

  • Develop a systematic understanding of knowledge and a critical awareness of the legal requirements for development and marketing of established active substances in the context of abridged applications and specialised products

  • Ability to identify, evaluate and connect the chemical/pharmaceutical, non-clinical and clinical data required 

  • Demonstrate a conceptual understanding of the processes and strategies to comply with the regulatory requirements, directives, and associated documentation with the strategy for abridged applications and specialised products that enables the student to evaluate critically current research and advanced scholarship in the discipline.

Skills and attributes:

  • Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of abridged applications and specialised products

  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complex data, and communicate their conclusions clearly to specialist and non-specialist audiences 

  • Critically appraise and evaluate communications from regulatory bodies and research publications.

CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

You can view and download an example programme based on previous courses here

Module Leaders

  • Eva Kopecna - Global Head of Regulatory Affairs, Medical and Pharmacovigilance, ACINO 

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. In addition to the module leaders listed above, previous speakers for this course include:


Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 £1,900.00 + VAT*
 Standard Price
 Non-member		 £2,375.00 + VAT* 
 TOPRA MSc Students
  		 £1,650.00 + VAT*

Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
 
 Discounted training course registration fees
 Event Registration Type Price (GBP)
 Government or academic rates
 TOPRA Member
 £1,425.00 + VAT*
 Government or academic rates 
 Non-member
 £1,781.25 + VAT*
 Charities, patient groups, full-time education rates
 TOPRA Member		 £950.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
  £1,187.50 + VAT*

Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
 

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

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

 
When
19/05/2026 - 21/05/2026
Where
TOPRA 3rd Floor City Reach 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
Registration begins 31/08/2025
My registration status: Not registered
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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