2024-12-03 2024-12-03 , online online, 1,590 € zzgl. MwSt. Dr. Monica Buchberger https://forum-institut.de/seminar/24122054-vendor-oversight-and-quality-management-in-ra-and-pv/referenten/24/24_12/24122054-seminar-vendor-oversight-quality-management-in-ra-and-pv_buchberger-monica.jpg Vendor Oversight and Quality Management in RA and PV

Outsourcing of activities, tasks or positions in regulatory affairs and pharmacovigilance is often standard practice. In this seminar, you will not only learn all you need to work with service providers, but also how to set up and monitor an effective vendor oversight programme in practice.

Topics

Legal requirements and guidelines
Local vs global outsourcing
Quality management and quality assurance in outsourcing activities
Subcontracts, SOPs, KPIs, training and auditing
Systems, budget control, the communication plan and more

Who should attend

The seminar is aimed at employees, managers and decision makers in the pharmaceutical industry who are involved in outsourcing PV and/or RA activities to external service providers, or monitoring them. It is also of interest to PV or RA service providers.

Employees in the following departments of international MAHs will benefit most from the event: pharmacovigilance, regulatory affairs, quality assurance (QA), quality control (QC) and business development.

Aims and objectives

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

When, why and what does it make sense to outsource?
Who is responsible for what?
How do I find the appropriate service provider?
What contractual agreements should I insist on?
How do I integrate the contractual partner into my QMS?
What training do my service providers need?
What is an oversight programme and which databases can/should I use?
Which KPIs are useful and how do I monitor them?
How do service provider audits work?

Your benefit

This seminar will enable you to

find and qualify the appropriate PV and RA vendors.
establish and improve your working relationships with new and existing service providers.
define the requirements for an effective (global) provider monitoring programme and know how to implement it.
set up and monitor appropriate KPIs for supplier performance.
define the key elements of supplier contracts.

Seminar Vendor Oversight & Quality Management in RA and PV

Vendor Oversight and Quality Management in RA and PV

Keeping track of your service providers

Benefits

Outsourcing and service provider oversight
Identifying appropriate vendors and KPIs
Includes examples and exercises for RA and PV
Officially certified to ISO 9001 and ISO 21001 standard

Webcode 24122054

Jetzt buchen

JETZT Buchen

Referenten

Alles auf einen Blick

Termin

04-05/12/2024

Zeitraum

Day 1: 09:00-17:00
Day 2: 09:00-13:00
You may dial in 30 min before the session starts

Veranstaltungsort

online

Downloads

Gebühr

Inhouse-Angebote

Your contact

Nadja Wolff
Conference Manager

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

Details

Topics

Legal requirements and guidelines
Local vs global outsourcing
Quality management and quality assurance in outsourcing activities
Subcontracts, SOPs, KPIs, training and auditing
Systems, budget control, the communication plan and more

Who should attend

Aims and objectives

When, why and what does it make sense to outsource?
Who is responsible for what?
How do I find the appropriate service provider?
What contractual agreements should I insist on?
How do I integrate the contractual partner into my QMS?
What training do my service providers need?
What is an oversight programme and which databases can/should I use?
Which KPIs are useful and how do I monitor them?
How do service provider audits work?

Your benefit

This seminar will enable you to

find and qualify the appropriate PV and RA vendors.
establish and improve your working relationships with new and existing service providers.
define the requirements for an effective (global) provider monitoring programme and know how to implement it.
set up and monitor appropriate KPIs for supplier performance.
define the key elements of supplier contracts.

Detailed programme

Day 1: 09:00-17:00
Day 2: 09:00-13:00
You may dial in 30 min before the session starts

08:45

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 Start of course

09:00 Welcome

09:15

Dr Monica Buchberger, Stephan Hütter

Introduction and what to expect from the seminar

09:30

Dr Monica Buchberger, Stephan Hütter

General principles of outsourcing

Reasons for outsourcing
When to outsource PV and RA
What to outsource in PV and RA
Pros and cons of outsourcing
Contractual considerations

10:45 Coffee break

11:00

Dr Monica Buchberger, Stephan Hütter

How to manage outsourcing

Essential controlling elements
What about subcontracting?
Setting up key performance indicators (KPIs)
Designing a governance structure
How to implement a communication plan
(Legal) responsibilities of the marketing authorisation holder (MAH)
Selecting the appropriate system
How to keep proper track of your budget
Developing an outsourcing programme

12:30 Lunch break

13:30

Dr Monica Buchberger

Deep dive - PV outsourcing

Good pharmacovigilance practices (GVP)
Pharmacovigilance agreements (PVAs)
Global vs local PV outsourcing
Quality management - KPIs, training and auditing
What to outsource and when
Responsibilities that remain with the MAH

15:15 Coffee break