Safety Data Exchange Agreements - Basics

Safety Data Exchange Agreements (SDEA) are legal contracts meant for ensuring prompt exchange of safety data with the business partner, that will ensure fulfilment of legal obligations by the marketing authorization holder (MAH).

Course Objectives:

1. Need for safety data exchange agreements (SDEA), and the regulatory requirement
2. Components of SDEA
3. Compliance Requirements

About the Course Facilitator: https://www.linkedin.com/in/drmanojswaminathan/

GVP Module VI states the following: “Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the submission of valid ICSRs within the appropriate time frames. These procedures should, in particular, specify the processes for the exchange of safety information, including the timelines and responsibilities for the regulatory submission of valid ICSRs. “ At the end of the day, the marketing authorization holder is accountable/ responsible for fulfilling all the Pharmacovigilance obligations. However, drug safety personnel need to have a business-friendly mindset, and there needs to be a perfect balance between patient safety and company priorities. Let us not forget that the regulatory agencies can even inspect business partners of the Marketing Authorization Holder.