Maximizing the Benefits of Safety Data Exchange Agreements: Key Considerations for Companies

Lisa Hughes shares her thoughts on Safety Data Exchange Agreements.

The pharmaceutical industry is a complex mixture of manufacturing, compliance, marketing and supply chain and depending on the size of your company and portfolio the relationships between the functions will need careful management.

When partnering with a third party whether that be another pharmaceutical company, Marketing Authorization Holder (MAH), service provider, or other stakeholders involved in pharmacovigilance related activities you may require a Safety Data Exchange Agreement (SDEA). An SDEA, or PV Agreement (PVA), is a structured document that ensures safety data is managed, and regulatory requirements are met by outlining the responsibilities of each party involved.  SDEAs and PVAs should detail how safety information must be captured, processed and reported to support the safety profile of the products concerned, this includes timelines for the exchange of data. Adhering to the agreement ensures all parties fulfil their obligations and ultimately protects patients as well as company reputation.

This is an important part of a robust pharmacovigilance system and there are different situations where an SDEA or PVA is required or where PV wording can be inserted into the Quality Technical Agreement (QTA) or the commercial agreement depending on the terms being negotiated. In my experience setting up approved templates for a full SDEA or PVA, wording for a QTA and commercial agreement and guidance on what to use when is crucial to ensure compliance, streamline operations and enabling best practice across all functions. It is very satisfying when a member of the sales force contacts PV to ask for an SDEA or PVA because they are aware of the need to have one due to the established relationship between PV and sales improving understanding of the requirements.

Remember to review the template periodically to ensure they still meet the business needs, in particular contact details are still correct. A review cycle should be implemented for SDEAs and PVAs, even if your company is not responsible for the agreement, this activity is likely to be reviewed during an authority PV inspection so it is vital you can evidence this.

If you need support with your SDEAs or PV agreements or for any other regulatory or pharmacovigilance work, please reach out to us at PharmaGuard Consultancy Ltd. My partner Jackie and I have a great deal of experience that we would love to share with you and support you in achieving your company goals. Contact us via the website form or email us at info@pharmaguard.co.uk