2024-07-25 2024-07-25 , 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

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

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

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

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

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

Details

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.

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 test
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00 Seminar begins


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


15:30

Dr Monica Buchberger

PV case studies

16:45

Questions

17:00 End of day one


09:00 Day two begins


09:00

Stephan Hütter

Review of day one

09:15

Stephan Hütter

Deep dive - RA outsourcing
  • Global vs local RA outsourcing
  • Quality management - KPIs and SOPs
  • Roles and responsibilities to be outsourced
  • What to outsource and when
  • Responsibilities that remain with the MAH

11:00

Stephan Hütter

RA case studies

12:45

Stephan Hütter

Summary, questions and discussion

13:00 Seminar ends


Further information

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.

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