Module 8: Data for Abridged Applications and Specialised Products

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Students will consider and evaluate practical aspects of regulatory strategy for abridged applications and specialised products; and explore and critically debate the regulatory issues likely to arise for abridged applications and specialised products in order to provide effective advice in this area.

Overview

This module enables regulatory professionals to develop their expertise in all aspects of the regulation, including the issues and the diversity of abridged applications. It also outlines the data requirements for a variety of different new dosage forms and new indications. Data requirements for certain specialised products are also covered. It allows students to examine the regulatory requirements imposed on abridged applications and specialised products.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Develop a systematic understanding of knowledge in 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
  • Have 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 them to evaluate critically current research and advanced scholarship in the discipline
  • Be able to identify, evaluate and connect the chemical/pharmaceutical, nonclinical and clinical data required for abridged applications and specialised products.

Skills and attributes

Successful students will typically:

  • 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 complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding abridged applications and specialised products
  • Critically appraise and evaluate communications from regulatory bodies and research publications regarding abridged applications and specialised products.

Focusing on specialised products and submissions? Consider:

  • Module 1: Strategic Planning in Regulatory Affairs
  • Module 6: Regulatory Strategy: From Development to the Market Place
  • Module 7: Regulatory Strategy for Established Active Substances
  • Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
  • Module 12: Data Management and Digitalisation in Regulatory Affairs

Expanding your options? Consider:

  • Module 3: Regulatory Requirements for a New Active Substance: Quality 
  • Module 11: The US Regulatory Environment
  • Module 18: Drug-device Combinations and Other Technologies
  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies