SDEA Partner Management
Do you have a lot of partners around the world and keep scratching your head how to manage exchange of data between all?
Are you handling several Pharmacovigilance Agreements and Safety Data Exchange Agreements and worrying it’s all a little too much?
Is your head spinning with all this?
Let’s just make this easy on ourselves!
Do you need to spend several hours each month just to check if all your safety data has really been reconciled with all parties involved?
Are you subcontracting performance of your pharmacovigilance responsibilities and need thorough documentation of this?
Is your head spinning with all this?
Let’s just make this easy on ourselves!
Is your head spinning with all this?
Automated
SDEA Reconciliation
Do you know that feeling of putting together a log of all exchanged cases at end of each month or collecting many different such trackers from your SDEA partners the first week of a month, sending them all back a confirmation message and then spend some fun time with putting all those trackers in one place (tracking trackers!)…?
There’s a very well-functioning pill for that headache.
It’s called Tepsivo Platform and our SDEA Reconciliation module.
Very simple – the Platform automatically generates a regular report that pulls all cases received from a specific SDEA partner tracked in any given period. At a selected date (1st of a month, let’s say), it’s automatically sent to the relevant parties who can then confirm it’s correct. Same way if you need to generate a report of the cases that you submitted during a given month to your partner.
All done with 0 minutes of manual work!
No magic here. Just using the right tools.
Pharmacovigilance Agreements and
Safety Data Exchange Agreements
Ask for quality, not quantity
Our approach to Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA) is simple: literally – to make them simple.
There has been this bad habit in the industry where documents like these have started to spread across 30-40 or more pages. As if that somehow made the agreement better quality. A good agreement is one that is concise and crystal clear to all parties, while meeting all legal obligations that may apply to.
Keep the contracts practical
From a practical standpoint, we highly recommend keeping PVAs and SDEAs in place with your distributors, licensees, or other partners who may potentially become aware of an adverse event to your medicinal product. It should be a quick point of reference to see where and when to report such events. That assumes the agreements are to the point and well-written.
Leverage templates to maximize efficiency
If you want to make sure your pharmacovigilance process across your team and in collaboration with your partners runs smoothly, your best shot is to put in place agreements that are easy to update and that everyone immediately understands.
The way to do it is using our PVA and SDEA Template.
Is SDEA legally required?
Understanding MAH’s obligations
First things first, there is a common misconception that SDEAs are by default legally required by pharmacovigilance regulations, especially in EU. That in and of itself is simply untrue, there isn’t any mention of a safety data exchange agreement anywhere in the pharmacovigilance-related law in the EU. It is a good practice to maintain SDEAs, but it isn’t a legal requirement.
What is a legal requirement, on the other hand, is to document any delegation of pharmacovigilance responsibilities as MAH (like when you decide to outsource pharmacovigilance services to Tepsivo).
.
The right SDEA template
Unless there is a commercial component to it, what we recommend in these cases is to put in place a Pharmacovigilance Agreement, and of course you can use our PVA template. The goal being a very clear split of responsibilities, as well as typical SDEA components such as reporting timelines, contact details, and addresses where to exchange data.
If there is a commercial component to the responsibility delegation (paying for services), easiest way to do this is by a detailed work order that, next to the budget, clearly describes the delegation of responsibilities, serving as a Pharmacovigilance Agreement or Safety Data Exchange Agreement, if you will.
Pro tip: Try to avoid consultants who sign a work order with you and claim
there’s a legal necessity of a separate SDEA (who they then charge you for developing).
For avoidance of doubt, Pharmacovigilance Agreement and Safety Data Exchange Agreement are interchangeable. Neither of these is in any way a legally codified term (such as Pharmacovigilance System Master File or Risk Management Plan).
At Tepsivo, we just say Pharmacovigilance Agreement.
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | [email protected] | +358 402 204 698 | Privacy policy
