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Research and Markets: Abridged Applications - Generics, Well Established Use & Mixed Product Licences Seminar: London, UK - 11-12th November 2014DUBLIN --(Business Wire)-- Research and Markets (http://www.researchandmarkets.com/research/wr9rnp/abridged) has announced the addition of the "Abridged Applications - Generics, Well Established Use & Mixed Product Licences (Seminar, London)" conference to their offering. This seminar is concerned with the current aspects of abridged applications and will include information on any new issues arising in relation to these applications. Safety, quality and efficacy will be addressed in an integrated fashion and the importance of application registration planning will be stressed. TOPICS TO BE COVERED: - The history & development of the legislation associated with Abridged Application - Quality issues - Bioequivalence Studies - The Summary of Product Characteristics - Clinical Issues - Pharmaceutical Issues WHO SHOULD ATTEND: - Managing Directors - Research and Development Directors - Medical Directors - Clinical Research Managers and Clinical Pharmacologists - Research and Development and Registration Managers - Pharmaceutical Development Managers - Quality Assurance Managers - New recruits to registration Key Topics Covered: Day One 09.30 - The legislation associated with Abridged Applications Dr Patrick Salmon 10.45 - Coffee 11.00 - Pharmaceutical Issues Norah Lightowler 12.15 - Discussion 12.30 - Lunch 14.00 - Case Study 15.15 - Tea 15.30 - Bioequivalence Studies Dr Patrick Salmon 16.45 - Discussion 17.00 - End of Day One Day Two 09.30 - Clinical Issues 10.45 - Coffee 11.00 - Pharmaceutical Issues - 2 Norah Lightowler 12.15 - Dicussion 12.30 - Lunch 13.45 - Case Study 2 14.15 - The Summary of Product Characteristics & Patient Information Leaflets 15.15 - Tea 15.30 - Pharmaceutical Requirements Norah Lightowler 16.30 - End of Meeting Speakers - Dr Patrick Salmon Senior Medical Officer, Irish Medicines Board, Dublin, Ireland, has been involved in all types of assessment including national, mutual recognition, decentralised and centralised applications. Dr Salmon is one of the Irish CPMP delegates and Chairman of the ad hoc group on the SmPC. Prior to joining the Irish Regulatory Authority he was Medical Director in the Irish office of a large international pharmaceutical company. - Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy. For more information visit http://www.researchandmarkets.com/research/wr9rnp/abridged |
