Data for Abridged Applications and Specialised Products

Data for Abridged Applications and Specialised Products
Module 8 of the MSc and Masterclass: 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.

: 8-10 November 2023
Where: Online
Day 1 start time: 09:00 GMT | Day 3 end time: 17:00 GMT

Also available as a face-to-face course, please click here for the face-to-face registration option.

Course overview

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.


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 


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:

Suitable for

  • 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 fees*:
    Type   Delegate
    Standard     £1,700 + VAT* 

    Discounted places
    A limited number of discounted places are available at the rates below. 
    Please note that discounted places are not valid for those enrolled on the MSc course.
    Please email us at for a discount code before making your booking. 

    Those working for regulatory agencies, government agencies or academic institutions 
     £1,275 + VAT*
    Those working for charities, patient groups or in full-time education
       £1,275 + 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.


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    08/11/2023 - 10/11/2023
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