SDEA & PVA Management.
Ensuring your vital agreements cover requirements and compliance.

What are SDEAs & PVAs?

Binding legal regulatory documents.

SDEA & PVA Management refers to Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs), which are often used interchangeably in the context of pharmacovigilance.

Both SDEAs and PVAs play a pivotal role within pharmacovigilance systems, representing formal written contracts mandating the exchange of safety data for medicinal products between business partners and Marketing Authorization Holders (MAHs). This exchange is essential to ensure compliance with legal regulatory obligations.

The development of SDEAs and PVAs involves explicitly outlining the detailed responsibilities of each party in relation to pharmacovigilance activities. This includes clearly defining timelines, regulatory obligations, and other aspects. The accuracy in defining these agreements is crucial not only for safeguarding patient safety but also because they are subject to scrutiny during audits and inspections.

Consequently, MAHs must integrate their SDEAs or PVAs into their Quality Management System, ensuring that these documents are continuously audit and inspection ready.

For Pharmacovigilance Audit and Inspection purposes SDEAs/PVAs should broadly cover:

  • The nature of the exchanged data.
  • Timelines governing the exchange of data.
  • Reconciliation measures.
  • Point of contact details.
    Implementation of adequate governance procedures.
  • Regulatory submission responsibilities.
  • Clearly defined responsibilities for late submissions and provisions for Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).

The context behind SDEAs & PVAs.

It is not cost-effective, and sometimes not permitted under local regulations, for MAHs to have affiliates, subsidiaries, or vendors and conduct Vendor Management in every country where they hold Marketing Authorisation, so an SDEA/PVA must be in place whenever a MAH enters into research, licensing, pharmacovigilance, product distribution etc. with a third-party organization or outsourced service provider.

SDEAs and PVAs are needed because the wide variety of contractual partners are each a potential source of safety information, and therefore the exchange of this information with MAHs becomes critical.

In accordance with the guidelines outlined in the European Medicines Agency’s (EMAs) Good Pharmacovigilance Practice (GVP) Module I, when a Marketing Authorisation Holder (MAH) expands its product portfolio through means such as acquiring another company or obtaining a new product, it must notify the relevant Qualified Person for Pharmacovigilance (QPPV).

They must evaluate the pharmacovigilance impact which requires a full understanding of the detailed sections within an SDEA/PVA information to ensure compliance.

Likewise, concerning the timely submission of valid Individual Case Safety Reports (ICSRs), GVP Module VI imposes stringent requirements for comprehensive contractual agreements and procedures between MAHs and third-party organizations and suppliers.

These agreements explicitly define the mechanisms for exchanging safety data and established schedules and responsibilities for the submission of valid ICSRs to regulatory authorities.

What is typically included within an SDEA or PVA?

SDEA and PVAs should typically include, but are not limited to, the following areas:

  • References to Master Service Agreements (MSAs).
  • Definitions, terminology, and acronyms.
  • Procedure for exchanging safety data.
  • Designation of products and territorial scope.
  • Identification of the safety database holder.
  • Specification of the mode of communication.
  • Protocol for exchanging literary information.
  • Exchange of Individual Case Safety Reports (ICSRs) – both serious and non-serious – and other safety information, with specified timelines.
  • Exchange of aggregate reports.
  • Detailed reconciliation processes.
  • Framework for the pharmacovigilance management system.
  • Information regarding the point of contact for all involved parties.
  • Adherence to regulatory compliance.
  • Provisions for audits and inspections.
  • Inclusion of clauses pertaining to data privacy and confidentiality.
  • Details of the business continuity plan.
  • Termination clauses.

Why choose Aegisana for SDEA & PVA management?

Agreement expertise.

Aegisana’s Compliance and Pharmacovigilance teams have extensive experience in understanding, creating, reviewing, and updating SDEAs and PVAs. Additionally, we offer a comprehensive management service to ensure the secure consolidation of these agreements in one centralized location.

Consolidation can be achieved by utilising your templates within a shared platform system, or by employing our own SDEA/PVA templates, managed within our internal change management system.

Seamless communication is facilitated through designated company e-mails, fostering effective collaboration with all stakeholders. We conduct annual reconciliation procedures to ensure that all responsible parties are current, thereby ensuring your full compliance and readiness for inspections.

Meticulous & detailed.

Our primary objective is to provide you with peace of mind and confidence through a meticulous and detailed service grounded in effective communication, reliability, and trust.

Through the establishment of a successful and robust strategic compliance partnership, we aim to offer comprehensive support across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.