2025-11-03 2025-11-03 , online online, 1,290 € plus tax Shanaka Thilak, PhD, M.B.A. https://www.forum-institut.com/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
  • General principles of outsourcing
  • Vendor choice and qualification
  • Contractual considerations
  • Quality management and quality assurance
  • Workshops on KPIs and risk-based audit planning


Who should attend
The training course is aimed at employees and managers in the pharmaceutical industry who are involved in outsourcing or monitoring PV activities to external service providers. The seminar is also of interest to PV service providers.
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 this 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
  • Overview: Outsourcing and quality management
  • Identifying the right vendors and KPIs
  • Including examples, exercises and online test
  • Officially certified to ISO 9001 and ISO 21001 standards

Webcode 26062050

Book now

JETZT Buchen
Speakers

Shanaka Thilak, PhD, M.B.A.

Independent Life Sciences R&D Consultant, London, UNITED KINGDOM

Independent Life Sciences R&D Consultant

Ivana Vukic, MPharm

Senior Pharmacovigilance & Quality Expert, Munich, GERMANY

Senior Pharmacovigilance & Quality Expert

Everything at a glance

Appointment

17/06/2026

17/06/2026

Period

09:00 - 17:00 CET
You may dial in 30 min before the session

09:00 - 17:00 CET
You may dial in 30 min before the session
Venue

online

online

Downloads
Abbreviation list Pharmacovigilance
Abbreviation list Pharmacovigilance
Fee

Event - 1,290 € plus tax
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space, the Online test as well as technical support including a test meeting.

Event - 1,290 € plus tax
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space, the Online test as well as technical support including a test meeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

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

  • General principles of outsourcing
  • Vendor choice and qualification
  • Contractual considerations
  • Quality management and quality assurance
  • Workshops on KPIs and risk-based audit planning


Who should attend
The training course is aimed at employees and managers in the pharmaceutical industry who are involved in outsourcing or monitoring PV activities to external service providers. The seminar is also of interest to PV service providers.

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 this 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 CET
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 of the MAH
  • Reasons for outsourcing
  • Responsibilities
  • Exercise: What to outsource and when?
  • Typical global challenges in cooperation: Public holidays, corruption, and more

10:45 - 11:00 Coffee break


11:00

Ivana Vukic, MPharm

Vendor choice and qualification
  • Exercise: Finding the right provider
  • Qualification and re-qualification
  • Outsourcing to developing countries: Risk or reward?
  • Local vs global outsourcing

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
  • 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

Shanaka Thilak, PhD, M.B.A.

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

16:15

Ivana Vukic, MPharm

Workshop: Risk-based audit plan

16:45 Closing Remarks and Q&A


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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