About the Regulatory Intelligence SPIN category

The aims of the group:

To provide a forum for members to share and build knowledge and ideas on Regulatory Intelligence (the act of collating, analysing and using regulatory data from multiple sources to gain a successful outcome).

To organise meetings, webinars and opportunities for the RI SPIN group.

To develop best practice guidelines and Q&As. For example, Preparing EU variations for first time approval using regulatory intelligence.

To feedback on Regulatory changes and interpretations.

To seek opportunities to collaborate with other SPIN groups, such as CMC, eRA, PV, CT, Medical Devices, Biotech in Webinars/knowledge-sharing.

The group should be:

An authoritative source of information on all aspects of Regulatory Intelligence

An arena for advice sharing on all aspects of Regulatory Intelligence

A point of clarity and guidance

A source of advice on:

What has been developed and accepted by different companies

What has been accepted by different authorities (European and National requirements)

European feedback.

Group Membership:

The group will only be open to the TOPRA membership.

The group will maintain a neutral stance with respect to vendors/consultants and will not permit software promotion in meetings.

The steering group are a “core team" to benefit new members where possible.

Leadership team to be reviewed annually to elect Steering Committee members.

Publicising the Group:

The TOPRA publications – In Touch and Regulatory Rapporteur - will be used to publicise the new team, both with adverts and articles.

The TOPRA website will also be used to keep members informed with respect to topics.

A Regulatory Intelligence SPIN Group Forum is set up to enable online discussions and collection of Frequently Asked Questions.