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:
| Office | Tenure | Name | Country |
|---|---|---|---|
| President | 1 yr | Prof Paolo Biffignandi | Italy |
| Past-President | 1 yr | Alan Hunter | UK |
| President-Elect | 1 yr | Zubair Hussain | UK |
| Office | Tenure | Name | Country |
|---|---|---|---|
| North America | 2 yrs | Carlos Langezaal | USA |
| Europe | 2 yrs | Dr Axel Wenzel | Germany |
| Office | Tenure | Name | Country |
|---|---|---|---|
| 2 yrs | Margareth Jorvid | Sweden | |
| 2 yrs | Angela Miller | UK | |
| 2 yrs | Niamh Lawler-Turner | Ireland | |
| 2 yrs | Patrizia Nestby | The Netherlands |
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:
| Name | Position | Organisation | Country |
|---|---|---|---|
| Prof. Rolf Bass | Office for Registration of Medicinal Products, Medical Devices and Biocides | URPL | Poland |
| Dr Daniel Brasseur | Chairman of the PDCO | Directorate General Public Health Protection - Medicinal Products | Belgium |
| Dr George Butler | President | SingEval | USA |
| Graham Higson | VP and Head of Global Regulatory Affairs | AstraZeneca | UK |
| Dr. Michael Holzhauser-Alberti | Affsaps | France | |
| Dr. David Jefferys | Global Strategic Regulatory & Product Development Advisor | Eisai Europe | UK |
| Dr Aginus Kalis | CEO | Medicines Evaluation Board | The Netherlands |
| Dr Murray Lumpkin | Principal Associate Commissioner | US Food & Drug Administration | USA |
| Dr Jytte Lyngvig | CEO | Danish Medicines Agency | Denmark |
| Dr Ann O'Connor | Director of Human Products Authorisation & Registration | Irish Medicines Board | Republic of Ireland |
| Prof. Tamas Paal | Director General | National Institute of Pharmacy | Hungary |
| Dr Markku Toivonen | Scientific Director | NDA | Finland |
| Noel Wathion | Head of Unit, Post Authorisation | EMEA | |
| Anne Wigmore | VP, European & International Regulatory Affairs | GlaxoSmithKline | UK |
| Kent Woods | Chief Executive Officer | MHRA | UK |
A number of other eminent regulatory figures have recently agreed to join TOPRA's Advisory Council and their names will be released shortly.
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:
If you would like more details of these groups, how to join and current activities, email info@topra.org
