2021-12-05 2022-04-06 , Online Online, 1.090,- € zzgl. MwSt. Dr. Susanne Enslin https://www.forum-institut.de/seminar/22042050-vendor-oversight-in-the-pharma-industry/referenten/22/22_04/22042050-online-course-vendor-oversight-ra_enslin-susanne.jpg Vendor Oversight in the Pharma Industry

Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme. Save your place today.

Topics
  • Local vs global outsourcing
  • Quality management and quality assurance in outsourcing activities
  • How to implement an effective worldwide regulatory vendor oversight programme
  • Budget control and KPI monitoring
  • Legal, contractual and liability aspects
Aims and objectives
Many healthcare companies are choosing to outsource regulated activities in Regulatory Affairs, Pharmacovigilance and other GxP areas. They remain responsible for ensuring that the services are in compliance with contractual and regulatory requirements.

Our seminar and workshop will explain how to implement an effective regulatory vendor oversight programme in your company and how to monitor quality, KPIs, budget and compliance.
Who should attend

This seminar addresses the needs of those working in the pharma and healthcare industries. It will particularly benefit the following departments involved in outsourced regulatory activities:

  • Regulatory Affairs
  • Pharmacovigilance
  • QA and QC
  • Business Development

GxP service providers are also invited to attend this seminar to exchange experiences.

The optional workshop on day 2 will provide practical insights into operational issues and specific cases and is highly recommended for the knowledge transfer.

Online-Course Vendor Oversight RA

Vendor Oversight in the Pharma Industry

Benefits
  • Online due to the current situation
  • Meet the experts!
  • Your questions will be answered
  • We are following the IMI quality criteria

Webcode 22042050

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

05. - 06.04.2022

05. - 06.04.2022

Zeitraum

Day 1: 09:00 - 17:15Day 2: 09:00 - 1...

Day 1: 09:00 - 17:15
Day 2: 09:00 - 16:00
The seminar on the 1st day can be booked separately. The workshop on the 2nd day can only be booked in combination with the seminar.

The times for breaks at online-seminars are scheduled individually.
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Sonja Wittemann
Conference Manager

+49 6221 500-696
s.wittemann@forum-institut.de

Details

Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme. Save your place today.

Topics
  • Local vs global outsourcing
  • Quality management and quality assurance in outsourcing activities
  • How to implement an effective worldwide regulatory vendor oversight programme
  • Budget control and KPI monitoring
  • Legal, contractual and liability aspects
Aims and objectives

Many healthcare companies are choosing to outsource regulated activities in Regulatory Affairs, Pharmacovigilance and other GxP areas. They remain responsible for ensuring that the services are in compliance with contractual and regulatory requirements.

Our seminar and workshop will explain how to implement an effective regulatory vendor oversight programme in your company and how to monitor quality, KPIs, budget and compliance.

Who should attend

This seminar addresses the needs of those working in the pharma and healthcare industries. It will particularly benefit the following departments involved in outsourced regulatory activities:

  • Regulatory Affairs
  • Pharmacovigilance
  • QA and QC
  • Business Development

GxP service providers are also invited to attend this seminar to exchange experiences.

The optional workshop on day 2 will provide practical insights into operational issues and specific cases and is highly recommended for the knowledge transfer.

Detailed programme

Day 1: 09:00 - 17:15
Day 2: 09:00 - 16:00
The seminar on the 1st day can be booked separately. The workshop on the 2nd day can only be booked in combination with the seminar.

The times for breaks at online-seminars are scheduled individually.

09:00 Beginning of the seminar on day 1


09:00

Introduction and technical warm-up

09:10

Dr Susanne Enslin

Vendor oversight
  • Why outsourcing?
  • Finding the right vendor
  • Local vs global outsourcing
  • Vendor qualification
  • Risk management and risk minimisation

11:00 Coffee break


11:15

Stephan Hütter

How to implement an effective worldwide regulatory vendor oversight programme
  • Elements of a vendor oversight programme
  • Useful and necessary databases for a regulatory environment

12:45 Lunch


13:45

Stephan Hütter

Financial and performance aspects
  • Budget control
  • How to define and monitor KPIs
  • Psychological factors

15:00 Coffee break


15:15

Stephan Hütter

Monitoring collaboration in practice
  • Essential SOPs and training
  • Vendor audit: Establish a risk-based approach

16:00

Dr Dr Adem Koyuncu

Legal, contractual and liability aspects
  • Outsourcing regulated activities: Options and limitations
  • Legal and GxP obligations
  • Who is liable in cases of non-compliance?
  • Typical practical issues and challenges of vendor oversight
  • Contracts with vendors: Key elements and recommendations

17:15 End of day 1


09:00 Beginning of the workshop on day 2


09:00

Stephan Hütter

KPIs for vendor oversight

09:45

Stephan Hütter

Budget control in detail

10:30 Coffee break


10:45

Dr Susanne Enslin

Training for vendors

11:15

Dr Susanne Enslin

Risk based vendor audits
  • Points to consider
  • Creation of a long-term audit plan

12:30 Lunch


13:45

Stephan Hütter

How to set-up a vendor oversight programme

15:00 Coffee break


15:15

Dr Susanne Enslin

Finding the right vendor/different scenarios

16:00 End of the workshop


Booking options

Seminar on day 1 (may be booked seperately)

The seminar in day 1 may be booked seperately.

Dienstag, 05.04. - 09:00 bis 17:15 Uhr
Dr Susanne Enslin, Stephan Hütter, Dr Dr Adem Koyuncu
Optional Workshop on day 2

Deepen the contents of day 1 with a practical workshop. The Workshop can only be booked in combination with the seminar.

Mittwoch, 06.04. - 09:00 bis 16:00 Uhr
Dr Susanne Enslin, Stephan Hütter

Further information

Your benefits

After the seminar, you will be able to

  • find and qualify the right vendor,
  • identify the necessary elements for an effective worldwide regulatory vendor oversight programme and implement them,
  • define and monitor KPIs for vendor performance and
  • effectively oversee the important elements of vendor contracts.

Send us your questions

Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions via e-mail to Sonja Wittemann: s.wittemann@forum-institut.de

This distinguishes our events

Seminar Content: 83% of the participants' feedback was very good or good (April 2021)

Overall impression Workshop: 100% of the participants' feedback was very good or good (April 2021)

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Go forward

Technical requirements

Here you can find the technical requirements for our online events that must be met.

Details
Technical requirements
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

Testimonials

Comment of former participants (October 2019)
I liked the workshop format very much.


Expectation to gain overview on the topic from different points of views was achieved.


Very good overview!

Comment of former participants (October 2018 )
The Course Content was well picked and easy to follow. Very clear with excellent presentation slides and real examples that you can relate to.


Good interaction between participants and presents. Relevant for performing Vender oversight.

Maria Lundberg

H. Lundbeck A/S Denmark


increased knowledge + very thought provoking. Example shared. Discussion-mainly a first two presenters.