TOPRA Community /Resource.phx/section/index.htx

TOPRA Special Interest Groups

The membership of TOPRA is in one sense very specialised in that it is focused on the profession of regulatory affairs. However, in other ways it is very diverse: our members come from over 50 countries of the world; they come from agencies, industry and service companies; and our membership spans all levels of experience in the profession from new recruits to the most senior figures who are recognised internationally.

The membership of TOPRA is also diverse in the sectors of healthcare it represents: members work in a variety of industrial sectors including pharmaceuticals, devices, biotechnology, animal health, cosmetics and complementary therapies. TOPRA recognises that for some of these sectors, there is very little support and so TOPRA has established a number of ‘Special Interest Groups’ (SIGs). The purpose of these is as follows:

to enable members working in specialist sectors to have contacts with other regulatory professionals in that sector
to provide a discussion forum where members of the SIG can exchange views and ideas and support each other
to ensure that the needs of these sectors are taken account of in the TOPRA training programme and to encourage their expert input into the content of our training meetings
to encourage contributions from the SIGs to the Regulatory Rapporteur on specialist topics

To date, TOPRA has established the following SIGs:

Biotechnology
CMC
Medical Technologies
United States
Veterinary

Members who would like to join a SIG are invited to e-mail spin@topra.org

Biotechnology

The TOPRA BioNet, special interest group is open to all TOPRA members who are interested in Biotechnology. This egroup offers the opportunity for TOPRA members to discuss issues relating to the development and regulation of biopharmaceuticals. As the TOPRA Biotech Working Party members are all members of this egroup, any requests relating to training or publications can be requested through the egroup.

CMC

The mission of this group is to provide a forum for regulatory affairs in the field of Chemistry and Pharmacy (CMC) and associated GMP issues in human and veterinary medicine.

The groups objectives are;

Facilitate information exchange with members and encourage new membership of TOPRA and the RegCMC SIG.
Raise the profile of RegCMC in pharmaceutical R&D and the regulatory process and thereby promote the role of RegCMC.
Encourage broad membership of the SIG (e.g. large and small pharma, consultants and regulatory authorities) and facilitate common understanding by means of discussion groups and education.
Facilitate RegCMC education and training in collaboration with the activities of CEBU.

This group has recently held the first of a planned series of teleconferences on technical topics of interest to members.

Medical Technologies

This sector is increasingly important and this is reflected in the range of activities of this group, which include:

Technical input to the MSc in Medical Technologies Regulatory Affairs, run in conjunction with Cranfield University
The production of one-day training courses on Medical Technology topics including those which are part of the CRED programme
Input on device topics to TOPRA's Introductory Courses
Development of the new Medical Technologies Symposium as a parallel track for the TOPRA Annual Symposium
Contribution of material for special medical technology editions of the Regulatory Rapporteur

Members of the SIG meet to exchange regulatory intelligence and experiences, particularly useful to those working in smaller companies.

United States

TOPRA now has a USA office in California to further serve the growing number of members in North America. Members are invited to join the Consultation Group which advises TOPRA on services that TOPRA members based in North America most need.

There is a management team that looks after membership, publications and meetings. The TOPRA inaugural meeting in the USA on 'Scientific Advice' was planned by this team.

If you would like to be part of this growing and dynamic group please email toprana@topra.org

Veterinary

TOPRA offers support to those working in this sector with a 'e' discussion group (TOPRAVetNet).

The team has developed two Veterinary Symposia, in 2006 in Amsterdam, The Netherlands and in 2007 in Copenhagen, Denmark. They are currently working on the Third TOPRA Annual Veterinary Symposium, taking place on 7 October in Budapest. Hungary.