This module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for OTC products. It will also examine the regulatory requirements imposed on established active substances.
Knowledge and understanding:
Skills and attributes:
Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements the type and range of abridged applications in Europe and the US, the legal background to abridged applications including data protection, marketing exclusivity and patent protection, options for abridged applications and use of the different regulatory procedures, strategy for abridged applications including implications for harmonisation of the SmPC, (Summary of Product Characertistics) processing of abridged applications by the regulatory authorities, particular issues for products containing well-established active ingredients, and generic and over-the-counter (OTC) products.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to put into context their understanding and knowledge.
Phillip Thornton is a pharmacist with 25 years in pharmaceutical research and development, including pharmacology, toxicology and clinical trials. He also has 19 years' experience in regulatory affairs consultancies involved in all areas of RA with mainstream and biological products for over 40 companies.
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.