PHARMA INTEGRITY

In-House Signatory Training

Case Study

Hike Group

In-House Signatory Training

CASE STUDY

Project Background

Our client’s Medical Director wanted to ensure signatories working across their full product portfolio were highly skilled in requirements and areas of enforcement so their review and approval of material and activities was of high quality and consistent across all therapy areas and brand teams.

Client Objectives

The client wanted the training to be relevant for the therapy areas and activities their company engaged in in Ireland, and to incorporate their internal standards and relevant processes. This would allow for a seamless alignment of internal and external requirements during the learning process. The individuals acting as or developing to be signatories held both medical and commercial responsibilities as the client approval processes required a business signatory as well as a medical signatory.

In-House Signatory Training

CASE STUDY

Our Solution

We customised our signatory training course to incorporate the client’s internal standards and procedures, and company history (case history, previous intercompany dialogue, undertakings, etc.). The four-week programme took delegates through the detailed internal and external requirements and demonstrated how these standards had to be met with practical examples and an ongoing programme of self-directed learning between sessions. Delegates developed their awareness of how to appraise different scenarios, assess risk, and communicate constructive feedback. As with our public courses, the programme concluded with a validation that assessed knowledge, judgement and decision-making skills.

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Hike Group

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