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.

Originally established in 1996, as the Biotech Working Party, our aim is to promote the development of realistic, common-sense and science-based approaches to the regulation of biological medicinal products by providing a sound understanding of the basic science and the available and emerging regulatory guidance via a focused education and training programme. Currently this consists of organising a number of TOPRA courses, including, Module 9 of the MSc in Regulatory Affairs, due to be run again in 2012, providing input to the TOPRA Annual Symposium and support and contributions to the publication of articles in Regulatory Rapporteur, most recently to a Biotech focused issue in January 2011. We are looking to further expand our range by offering more frequent and informal opportunities to share and learn and as part of this initiative joined with the CMC SPIN on 29th September 2010 for a technical discussion on the new EU Variations Regulation.

Our membership is growing and currently stands at over 40 members, who are involved in the full spectrum of applications of biotechnology and biologicals within the biopharmaceutical industry (recombinant proteins, monoclonal antibodies, vaccines and advanced therapies), all disciplines of regulatory affairs for these products, (CMC, Preclinical and Clinical and regulators) and all sizes of company.

Those who apply for membership are encourage to contribute and can 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 and become actively involved with the activities of the SPIN Steering Group.

Join the Biotech SPIN

To get involved with the Biotech SPIN today please e-mail a request to join with your TOPRA membership number to biotechspin@topra.org.

Click here to access the Biotech Members' Area.

To become a TOPRA member please click here.