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 | Patrizia Nestby | Netherlands |
| Past-President | 1 yr | David Jeffreys | UK |
| President-Elect | 1 yr | Jonathan Trethowan | UK |
| Office | Tenure | Name | Country |
|---|---|---|---|
| North America | 2 yrs | Patricia Duchene | US |
| Europe | 2 yrs | Áine Kane | UK |
| Office | Tenure | Name | Country |
|---|---|---|---|
| 2 yrs | Sarah Roberts | UK | |
| 2 yrs | Niamh Lawler-Turner | Ireland | |
| 2 yrs | Steve Brookes | UK | |
| 2 yrs | Christine Mayer-Nicolai | Germany | |
| 2 yrs | Ljiljana Markus-Cizelj | Croatia |
See biographies of the current Board Members
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 | Visiting Professor for Pharmaceutical Medicine | University Hospital of Basel | Switzerland |
| Nicola Bedlington | Director | European Patients' Forum | Belgium |
| Dr Daniel Brasseur | Chairman of the PDCO | Directorate General Public Health Protection - Medicinal Products | Belgium |
| Dr Axel Breitstadt | Executive Director Regulatory Affairs Europe | Merck Sharp & Dohme | Belgium |
| Dr George Butler | President | SingEval | USA |
| Dr Michael Holzhauser-Alberti | Deputy Head of Unit, Pharmaceuticals Assessment | ANMV | France |
| Prof Rui Santos Ivo | Professor, Medicines Regulation | University of Lisbon Faculty of Pharmacy | Portugal |
| Vice-President | Central Administration of the Health System (ACSS) | ||
| Aginus Kalis | CEO | Medicines Evaluation Board | The Netherlands |
| Dr Murray Lumpkin | Principal Associate Commissioner | US Food & Drug Administration | USA |
| Ann O'Connor | Director of Human Products Authorisation & Registration | Irish Medicines Board | Republic of Ireland |
| Dr Markku Toivonen | Scientific Director | NDA | Finland |
| Dr Mel Walker | VP, Head of Market Access | Otsuka Europe | UK |
| Prof Sir Kent Woods | Chief Executive Officer | MHRA | UK |
The Secretariat
TOPRA has headquarters offices in London UK, manned by staff who 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 Networks
Special Interest Networks cover areas that change rapidly, are particularly scientifically challenging or are currently regarded as 'niche' areas of regulatory activity. They allow members to exchange information and regulatory intelligence.