MSc in Regulatory Affairs: Module 8 - Data Requirements for Abridged Applications and Specialised Products

Module 8 Brochure

Aim

The purpose of this module is to provide an understanding of the diversity of abridged applications,and to outline the data requirements for a variety of different new dosage forms and new indications.The module also covers consideration of the data requirements for certain specialised products.

Learning outcomes

• Students will be able to identify the chemical/pharmaceutical, preclinical and clinical data required for line extensions taking into account the interaction between the various parts of a dossier.
• Students will gain an understanding of the requirements for bridging data in various situations.
• Students will gain an understanding of the data requirements for generic applications and for a number of specialised products.
• Students will gain an understanding of the data requirements for Supplemental applications in the USA.

Outline of Module topics

• Discussion of various types of line extension including new routes of administration, new dosage forms and new indications
• Chemical and pharmaceutical requirements for line extensions including Drug Master Files
• Bioequivalence
• Preclinical requirements for abridged applications
• Clinical data requirements for line extensions
• Discussion of particular product categories such as novel delivery systems, sustained release products, combination products and inhalation products
• Requirements for drug/device combinations
• Radiopharmaceuticals
• Blood products
• Herbal medicines

Links with other Modules

• Module 7 covers regulatory strategy for submissions for established active substances.
• Module 2 covers preclinical aspects of the regulatory strategy for a new active substance.
• Module 3 covers the regulatory requirements for chemistry and pharmacy for a new active substance.