Case Studies

Pharmacovigilance preparation for product launch

Pharmacovigilance / USA

Insight

Our client, a fast growing company, had recently received recommendation for approval by the FDA Advisory Committee and needed to show the FDA they had the infrastructure to support their product.

Idea

Ashfield Pharmacovigilance proposed a plan that would assist in the client’s staffing needs and adhere to their strict timelines.  To do this, Ashfield Pharmacovigilance quickly recruited skilled team members to assist in all facets of product launch preparation, putting the right people in the right places. Support included multiple Medical Science Liaisons and Medical Writers with pharmacology backgrounds to assist with writing needs.

Impact

As a result, Ashfield Pharmacovigilance assisted with their Risk Evaluation and Mitigation Strategy (REMS) and created a training plan for their sales force (provided by Ashfield Commercial). We provided sales force training both online and in the classroom.  Additionally, an MSL training plan was created.  Our Medical Writers audited seven training modules from pharmacology perceptive and also created medical information letters, such as a standard response letter which summarized clinical trial data, prescribing information, and published scientific journal findings.

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