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Organisation
The Board The Board of Directors is the legally and financially responsible body that sets the strategic direction of TOPRA and makes sure that all is running smoothly. Members of the Board are elected at the Annual General Meeting and any member, wherever they live or whatever their regulatory experience, can stand for election.
The positions on the Board and their length of tenure are:
Executive Members Business Unit Heads (4-5) 2 years Regional Development Directors 2 years Board Members without portfolio (up to 4) 2 years The Advisory Council The Board of TOPRA is very fortunate to be able to call on expert members of its Advisory Council for guidance on future directions. Appointed for terms of service of two years, the members of the Council represent some of the greatest names in International Regulatory Affairs. All members of TOPRA can make recommendations to the Board, in confidence, for new Advisory Council members. The Council meets twice a year and provides a valuable external perspective on Regulatory Affairs and the needs of professionals in the discipline.
Council Members are:
Prof. Rolf Bass Office for Registration of Medicinal Products, Medical Devices and Biocides URPL Poland
Dr Daniel Brasseur Chairman of the CHMP Directorate General Public Health Protection - Medicinal Products Belgium
Dr George Butler SingEval, President USA
Michael Doherty Global Head of Regulatory Affairs Roche Switzerland
Graham Higson VP and Head of Global Regulatory Affairs AstraZeneca UK
Dr Paul Huckle SVP Regulatory Affairs Dr. David Jeffreys Global Strategic Regulatory & Product Development Advisor Eisai Europe UK Dr Aginus Kalis CEO Medicines Evaluation Board The Netherlands
Dr Jytte Lyngvig CEO Danish Medicines Agency Denmark
Prof. Tamas Paal Director-General National Institute of Pharmacy Hungary
Dr Ann O'Connor Medical DEvices Director Irish Medicines Board Republic of Ireland
Dr Markku Toivonen Scientific Director NDA Finland
Dr Murray Lumpkin Principal Associate Commissioner US Food & Drug Administration USA
Dr Daniel Brasseur Chair of PDCO at EMEA Agence Fédérale des Médicaments et des Produits de Santé Belgium
A number of other eminent regulatory figures have recently agreed to join TOPRA's Advisory Council and their names will be released shortly.
The main areas of activity of TOPRA are co-ordinated by four main business units. Continuing Education and Training: responsible for all the training meetings and events organised by TOPRA. Qualifications: responsible for TOPRA’s postgraduate degree courses in Regulatory Affairs, the appointment of Fellows and Honorary Life Members and the evaluation of further professional qualifications. Information Services: responsible for the journal Regulatory Rapporteur, the newsletter In Touch, other publications and this website. Membership Development and External Relations: responsible for the evaluation and implementation of new services to members, for promoting TOPRA to potential new members and maintaining its profile with other key organisations.
Each business unit has a management committee headed by a Board member and a variety of standing committees and ad-hoc working groups to deal with all the activities of the business unit. Members of TOPRA are encouraged to join these committees and working groups to make their contribution to TOPRA – which can have many rewards both personally and professionally. § The Secretariat
TOPRA is fortunate to have headquarters offices in London UK, manned by staff which can provide the support needed by the members in running the Organisation. Any member can contact the office and express an interest in being involved in TOPRA at any level. § Special Interest Groups
TOPRA aims to serve the interests of regulatory professionals whatever their specific area of interest. Areas that change rapidly are particularly scientifically challenging or currently regarded as ‘niche’ areas of regulatory activity all lend themselves to being served by Special Interest Groups. These groups allow members to get together to exchange information and regulatory intelligence. The groups can also advise the training and education business units on areas they should be addressing, or contribute information to the journal for the benefit of the wider membership.
Currently, TOPRA has Special Interest Groups in the following areas: Biotechnology Medical Technologies Complementary medicines CMC Regulatory Affairs e Regulatory Affairs
A group is being being planned (subject to interest) in Veterinary Regulatory Affairs. If you would like more details of these groups, how to join and current activities, click info@topra.org
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