Biotech Special Interest Network

We would welcome the opportunity to have you as a member of the Biotech Special Interest Network (SPIN). The Biotech SPIN is open to all TOPRA members with involvement or an interest in the biopharmaceutical industry and the regulation of biological medicinal products. Our current members are involved in the full spectrum of applications of biotechnology and biologicals within the biopharmaceutical industry (recombinant proteins, monoclonal antibodies, vaccines and advanced therapies) and all disciplines of regulatory affairs for these products, (CMC, Preclinical and Clinical and regulators). Those who apply for membership are added to e-mail network through which members can raise question to draw on the knowledge of the network members. As the network is there to serve the members, you can influence the development and format of the network. Biotech SIG members can also become involved with the activities of the Biotech Working Party. To get involved with the Biotech SPIN today please e-mail a request to join with your TOPRA membership number to biotechspin@topra.org.

Biotech Steering Group

The Biotech Steering Group was established in 1996. Its aim is to promote the development of a realistic, common-sense and science-based approach to the regulation of biologicals by providing a sound understanding of the basic science and the available and emerging regulatory guidance via a focused education and training programme. This consists of organising 7 TOPRA courses, run over a two-year cycle, an MSc Module (module 9) and input to the TOPRA Annual Symposium that takes place this year in Stockholm. We also encourage the publication of articles in Regulatory Rapporteur.

As the objectives of the Steering Group are primarily to provide training and support to other TOPRA members to enable them to understand, interpret and influence the development of guidelines, it is paramount that the members of this committee are trained in and are currently working in the field of biological Regulatory Affairs. Therefore unlike other groups there are criteria for membership of the working party.

TOPRA Biotechnology Steering Group members are required to:

• Be members of TOPRA
• Have a minimum of 3 years experience of working in the area of biological Regulatory Affairs. Members working in CRO’s must be responsible for the co-ordination and completion of biological projects.
• Attend at least 2 meetings per year whether by phone or in person
• Take responsibility for at least one activity

Click here to access the Biotech Members's Area.

Membership Contact

If you would like to further your involvement with TOPRA Biotech Special Interest Network by applying to join the Steering Group we would be delighted to hear from you. Just e mail a copy of your CV to biotechspin@topra.org

e-network: TOPRABioTechNET

To become a TOPRA member please click here.