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SDEA Management in Pharmacovigilance
- 1. www.vigiserve.org www.vigilearn.org www.inopp.orgwww.inopp.org Safety Data Exchange Agreements Management Process 22-Aug-2020
- 2. www.vigiserve.org www.vigilearn.org www.inopp.org LEGAL PARTNER SAFETY SALES Collaboration Stakeholders in SDEA Management Legal – Both MAH & Partner Pharmacovigilance Sales & Marketing Distributor/ Business Partner
- 3. www.vigiserve.org www.vigilearn.org www.inopp.org Parties to SDEA INTERNAL Affiliates/ Subsidiaries Business Functions Batch Release Site Service Provider Exploitant VENDOR With the Acquirer/Acquiree M&A Local/Contractual QPPV Local Qualified Persons Distributor/ Other Partners, Co-Marketing/Co-Licensing Innovator/RLD Owner Business Partner
- 4. www.vigiserve.org www.vigilearn.org www.inopp.org 432 BiPartite SDEA TriPartite SDEA QuadraPartit eSDEA Number of Parties
- 5. www.vigiserve.org www.vigilearn.org www.inopp.org •Legal •Validity and Revision timelines •Termination •Products and Territory Legal & Admin •Timelines and mechanism for Exchanging safety data •Reconciliation processes •Language (and/or translation) •Data Privacy & BCP Info Exchange •Responsibility matrix •Safety-related recalls •Quality & Audits Safety Sections of an SDEA
- 6. www.vigiserve.org www.vigilearn.org www.inopp.org More Common Own-Label Supply Licensing, Co- Marketing, Local MAH Vendor, M&A, Internal, etc. 1 2 3 4 Types of SDEA Distribution Private Label Licensing Service
- 7. www.vigiserve.org www.vigilearn.org www.inopp.orgwww.inopp.org Authorized Representative Vetted by Legal Executing an SDEA
- 8. www.vigiserve.org www.vigilearn.org www.inopp.org Completeness LEGAL Correctness. Company Interests Liabilities Ready for Execution? Reviewing the Agreement Drafting the Agreement Role of Legal Department
- 9. www.vigiserve.org www.vigilearn.org www.inopp.orgwww.inopp.org What did we Learn? • Stakeholders in SDEA Management • Parties to SDEA Management • Components of SDEA • Types of SDEA • Execution of SDEA
- 10. www.vigiserve.org www.vigilearn.org www.inopp.orgwww.inopp.org SAY HELLO info@vigiserve.com SUBSCRIBE www.linkedin.com/company/vigiserve/ www.facebook.com/vigiserve www.Instagram.com/vigiserve www.twitter.com/vigiserve www.vigiserve.org/don ate
Editor's Notes
- We will now learn about the management process for safety data exchange agreements, or SDEA.
- Let us first understand the various stakeholders in SDEA management. The first stakeholder is the Pharmacovigilance or the drug safety department, that needs SDEA for ensuring and demonstrating compliance, as this is a regulatory requirement. The second stakeholder is the marketing or sales team of the marketing authorization holder. This team is responsible for establishing business relationship with the distributors. The next stakeholder is the business partner, which is required to ensure compliance with timely exchange of data. The last stakeholder is the legal team, that needs to ensure completeness of SDEA, and verify its executability. All the four stakeholders need to work in sync with each other, and ensure appropriate collaboration.
- We will now learn about the parties to SDEA. By party, we mean the partner with which the M A H needs to execute the SDEA. For convenience, we have divided these parties into five different groups. The first one is the business partner, that includes distributors, co-marketing or co-licensing partners, tender partners, or even innovator or RLD owner, in case of Para 4 filing related arrangements in the United states. Besides, this can even include Government or regulatory agencies. Second type pertains to local pharmacovigilance responsible persons, including the local or contractual QPPV. Third type pertains to vendors and service providers. This even includes the Exploitant in France. Next type pertains to Internal customers, or affiliates, subsidiaries, or even batch release sites. In some companies, SDEA is even executed with the business functions. The last type pertains to partners associated with merger and acquisitions. This is generally considered during the transition phase, between the two companies.
- Whenever we think of an agreement, we would consider that it is between two parties. However, the number of parties may be three, or even four. Bipartite SDEA is the commonest arrangement, where an SDEA is executed between two partners. Tripartite SDEA, When there are three parties involved in a business arrangement. Example, When a company or M A H wants to outsource pharmacovigilance operations in France, and there is an Exploitant involved. A tripartite agreement may even be required when a distributor is incapable of fulfilling Pharmacovigilance obligations, where a local service provider may need to get involved. Quadrapartite SDEA; This is a rare scenario where four parties are involved in executing an SDEA. Example, when there is an M A H, distributor, service provider and a local QPPV.
- We will now learn about the various sections of an SDEA. There are broadly three sections in an SDEA. First is the safety section, that comprises of various pharmacovigilance related clauses, along with a responsibility matrix. This may even include some quality related parameters like audits, product complaints or even recalls, that may have a bearing on patient safety. The second section pertains to information exchange. This includes the Timelines and mechanism for Exchanging safety data, Reconciliation processes, Language and/or translation, medium of exchange, or even Data Privacy and business contingency planning. The third section pertains to administrative and legal aspects. These include the legal clauses, scope of agreement, products and territories, and even validity and revision timelines.
- We will now learn about the types of SDEA. The different types include, Distribution, private label, licensing type, and service related. The distribution agreement is the most common type of SDEA, where there is a partner that distributes the company, or M A H product in one or more territories. Second type is the Private label SDEA, where a business partner my commercialize a product using its own label and packaging. These agreements may also be called as O L S agreements. In this case, business partner does not hold any product licence. The third type is the licensing arrangement. This may be out-licensing, or even in-licensing. Here, the business partner may or may not have exclusivity to commercialize a product. We can even have co-marketing arrangements, where more than one company may commercialize a product in the same territory. At times, the business partner may even hold a local license in that territory. The fourth type is the service arrangement, where we can have a vendor, which may be a service provider. This agreement may even be executed with company affiliates or subsidiaries. In case of merger and acquisitions, companies may engage into this kind of SDEA.
- Who can Sign-off or execute the SDEA? The Pharmacovigilance head or designee can sign off an SDEA only if he or she has been authorized by the company board If not, then the execution can be performed by any other authorized designee. In such cases, the designee may exercise caution and get the agreement vetted by the legal, before sign off.
- The legal department is one of the most important stakeholders in SDEA management. They should necessarily be involved in Drafting the template. The concept of 'one standard template' is hypothetical in the real sense, as there is no 'one size fits all' concept, and every business partner would suggest some changes before the agreement gets finalized. Legal team is also involved in Review of SDEA, especially when it is the partner's template or there are amendments suggested by the partner.
- What did we learn today? We learn about the stakeholders in SDEA management along with their Roles & Responsibilities, parties to SDEA management, various components or sections of SDEA, the types of SDEA, and the process of e We trust you found this useful.
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