Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass - EU edition

The agreements between pharmaceutical companies marketing a certain product should include agreements (so called Safety Data Exchange Agreements, SDEAs) to ensure the adequate flow of any arising safety concerns.

28-29 April, 2025, Virtual
Time Zone: UTC/GMT+1 /CET

Overview

It is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at any point is adequately captured, distributed and adequately and timely reported. The risk benefit ratio should be maintained at all times and for this reason agreements between pharmaceutical companies marketing a certain product should include agreements (so called Safety Data Exchange Agreements, SDEAs) to ensure the adequate flow of any arising safety concerns.

This should also be considered in all outsourced activities of a pharmaceutical company that may lead to any capture of safety information related to the products of which the company is the Marketing Authorization Holder (MAH)

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RECOMMENDATION

Who should attend?

Pharmacovigilance professionals
Auditors and PV Auditors
Medical Affairs Professionals involved in outsourced Medical Activities as Advisory
Boards, Congresses, etc
Marketing Professionals working in outsourcing activities
Legal Department Professionals