Data for Abridged Applications and Specialised Products

Data for Abridged Applications and Specialised Products
Module 8 of the MSc: 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: 28-30 November 2018
Where: De Vere Latimer Estate, Chesham, UK
Start time (Day 1): 16.00
End time (Day 3): 17.00

 

What is it?

This course is intended for those already working with or would like to learn more in the field of regulatory strategy and data requirements for abridged applications (generics) and specialised products, including herbals, drug/device combination, radiopharmaceuticals, cosmetics, inhalation and blood products, and students who are completing the TOPRA MSc in regulatory affairs. Attendees are going to expand their knowledge of this area and will cover CMC data requirements for drug substance and product for established molecules, CMC data requirements, bioequivalence, clinical and non-clinical considerations for abridge applications and  testing strategies, revision of strategic issues for abridged applications from a regulatory agency perspective, on abridged applications, and strategic issues of herbals, drug/device combination, radiopharmaceuticals, inhalation, blood products, cosmetics and abridged US options.


What will I learn?

Knowledge and understanding:

  • Develop a systematic understanding of knowledge and a critical awareness of the legal requirements for development 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: 17
To learn about why CPD is important visit the Lifelong Learning page. 

Programme

To download the course agenda, click here

How do I apply? 

Course fees:
Type Student Non-Student
Standard    £1500+VAT £1700+VAT 

Discounted places
A limited number of discounted places are available for those working in regulatory agencies, government bodies, charities or patient groups . Please email us 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 

Travel and accommodation is not included. You will receive information on how to book accommodation and special rates once you have booked onto the course. The special bed and breakfast rate is £99.00 plus VAT per night. 

The discounted rate is limited to six weeks prior to the start of the module and may change subject to availability, so please ensure you book as soon as possible.
When
28/11/2018 - 30/11/2018
Where
De Vere Latimer Estate Chesham HP5 1UG UNITED KINGDOM
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