2026-05-29 2026-05-29 , online online, 1,290 € zzgl. MwSt. Shanaka Thilak, PhD, M.B.A. https://www.forum-institut.de/seminar/26062050-outsourcing-and-vendor-management-in-pharmacovigilance/referenten/26/26_06/26062050-seminar-outsourcing-and-vendor-management-in-pv_thilak,-phd,-mba-shanaka.jpg Outsourcing and Vendor Management in Pharmacovigilance

Outsourcing of areas, tasks, or positions in pharmacovigilance is often standard practice. In this training course, you will not only gain the necessary knowledge to work with service providers but also learn in practice how to monitor them effectively and manage a robust quality system.

Topics
  • Regulatory framework and responsibilities for PV outsourcing
  • Vendor selection, qualification, and onboarding
  • Contractual considerations
  • Quality assurance, performance monitoring, and defining the right KPIs
  • Supplier oversight and risk-based audit planning


Who should attend
This training course is designed for pharmacovigilance professionals as well as colleagues from Quality Assurance and Compliance who are involved in selecting, qualifying, contracting, and overseeing PV service providers.

It is particularly relevant for Marketing Authorisation Holders (MAHs) and their teams responsible for vendor governance. PV service providers supporting clients with quality systems, audits, and inspection readiness will also benefit.
Aims and objectives
Outsourcing in pharmacovigilance (PV) is common practice. However, the main responsibility for ensuring that the services meet regulatory requirements remains with the marketing authorisation holder (MAH). This raises a number of questions that our experts will answer:
  • When, why and what makes sense to outsource?
  • Who is responsible for what?
  • How do I find the right service provider?
  • What contractual agreements do I have to insist on?
  • How do I integrate the vendor into my QM system?
  • What training do my service providers need?
  • Which KPIs are useful and how do I monitor them?
  • How should audits of the service provider be conducted?
Your benefit

After the seminar, you will be able to...

  • identify and successfully qualify the right PV vendors.
  • improve your working relationship with existing and new service providers.
  • define the key elements of supplier contracts.
  • set and monitor appropriate KPIs for supplier performance.
  • establish the necessary requirements for an effective PV quality system at your service providers.

Course - Outsourcing and Vendor Management in PVSeminar Outsourcing and Vendor Management in PV

Outsourcing and Vendor Management in Pharmacovigilance

Keeping track of your service providers

Benefits
  • PV outsourcing and quality oversight
  • Identifying the right vendors and defining meaningful KPIs
  • Real-world examples, exercises, and online test
  • Officially certified to ISO 9001 and ISO 21001

Webcode 26062050

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Referenten


Alles auf einen Blick

Termin

17/06/2026

17/06/2026

Zeitraum

09:00 - 17:00 CE(S)T
You may dial in 30 min before the session

09:00 - 17:00 CE(S)T
You may dial in 30 min before the session
Veranstaltungsort

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Outsourcing of areas, tasks, or positions in pharmacovigilance is often standard practice. In this training course, you will not only gain the necessary knowledge to work with service providers but also learn in practice how to monitor them effectively and manage a robust quality system.

Topics

  • Regulatory framework and responsibilities for PV outsourcing
  • Vendor selection, qualification, and onboarding
  • Contractual considerations
  • Quality assurance, performance monitoring, and defining the right KPIs
  • Supplier oversight and risk-based audit planning


Who should attend
This training course is designed for pharmacovigilance professionals as well as colleagues from Quality Assurance and Compliance who are involved in selecting, qualifying, contracting, and overseeing PV service providers.

It is particularly relevant for Marketing Authorisation Holders (MAHs) and their teams responsible for vendor governance. PV service providers supporting clients with quality systems, audits, and inspection readiness will also benefit.

Aims and objectives

Outsourcing in pharmacovigilance (PV) is common practice. However, the main responsibility for ensuring that the services meet regulatory requirements remains with the marketing authorisation holder (MAH). This raises a number of questions that our experts will answer:

  • When, why and what makes sense to outsource?
  • Who is responsible for what?
  • How do I find the right service provider?
  • What contractual agreements do I have to insist on?
  • How do I integrate the vendor into my QM system?
  • What training do my service providers need?
  • Which KPIs are useful and how do I monitor them?
  • How should audits of the service provider be conducted?

Your benefit

After the seminar, you will be able to...

  • identify and successfully qualify the right PV vendors.
  • improve your working relationship with existing and new service providers.
  • define the key elements of supplier contracts.
  • set and monitor appropriate KPIs for supplier performance.
  • establish the necessary requirements for an effective PV quality system at your service providers.

Detailed programme

09:00 - 17:00 CE(S)T
You may dial in 30 min before the session

08:45 - 09:00

Technical warm up
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.

09:00 Welcome and introduction


09:15

Shanaka Thilak, PhD, M.B.A.

General principles of outsourcing
  • Legal background
  • Impact of the Commission Implementing Regulation (EU) 2025/1466
  • Responsibilities
  • Reasons for outsourcing
  • Typical challenges in global cooperation
  • Exercise: What to outsource and when?

10:45 - 11:00 Coffee break


11:00

Ivana Vukic, MPharm

Vendor choice and qualification
  • Commercial partners vs PV vendors
  • Types of PV vendors
  • Qualification and re-qualification
  • Outsourcing to developing countries
  • Local vs global outsourcing
  • AI in outsourcing?
  • Exercise: Finding the right provider

11:45

Shanaka Thilak, PhD, M.B.A.

Contractual considerations
  • Sub-contracting, PV-Agreement, SDEA, and information exchange agreement - which contract type for which purpose?
  • Exercise: Essential and possible contract contents

12:30 - 13:30 Lunch break


13:30

Ivana Vukic, MPharm

Quality management and quality assurance
  • Integration into quality management system
  • Essential controlling elements (KPIs, audits and more)
  • Vendor training
  • Interfaces with internal GxP functions

14:45

Ivana Vukic, MPharm

Workshop: Setting up the right key performance indicators (KPIs)

15:15 - 15:30 Coffee break


15:30

Both speakers

How to manage outsourcing?
  • How to design a governance structure
  • Setting up and managing an oversight programme
  • PV related data flow
  • How to implement a communication plan?
  • How to do proper budget tracking?

16:15

Ivana Vukic, MPharm

Workshop: Risk-based audit plan

16:45

Both speakers

Summary and Q&A session

17:00 End of seminar


Further information

An interactive seminar with learning assessment and certificate

This event offers a combination of solid theoretical principles, practical workshops, and interactive discussions. To maximise your learning experience, we kindly ask you to keep your camera on whenever possible and actively participate.

After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space to assess your learning progress. Upon successfully passing the test, you will receive a certificate recognized for its compliance with inspection standards, along with your certificate of attendance.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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