Outsourcing & Vendor Oversight in Regulatory Affairs
Practical half-day training to strengthen vendor selection, performance management and oversight.
- Practical framework for RA outsourcing
- Tools and methods for vendor selection & maintenance
- All the essentials in just half a day
- Officially certified according to ISO 9001 and 21001
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
FROM 9:00-13:00 CET
Booking details
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
FROM 9:00-13:00 CET
Overview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a day
Your speaker
Stephan Hütter
CENCORA PharmaLex GmbH, Mannheim, GERMANY
Director Global Program Management / Regional Lead LATAM
Your speaker
Stephan Hütter
CENCORA PharmaLex GmbH, Mannheim, GERMANY
Director Global Program Management / Regional Lead LATAM
What to Expect
- Foundations of outsourcing in regulatory affairs
- Vendor selection & risk assessment
- Set-up & management of outsourced processes
- Maintaining oversight & ongoing compliance
Who Should Attend
- RA professionals new to outsourcing who need a practical framework for vendor selection and oversight.
- RA professionals with outsourcing experience who want to update and deepen their know-how.
- QA, PV, project management, procurement and other adjacent functions supporting the management of outsourced regulatory activities.
A solid background in EU marketing authorisation processes is required.
Objective of the Event
This half-day seminar provides a practical introduction to outsourcing and vendor oversight in regulatory affairs. Based on a structured, step-by-step approach, you learn how to decide when outsourcing makes sense, how to select and qualify vendors in a risk-based way, and how to set up governance, communication and performance management for outsourced RA activities.
The seminar also addresses how to maintain effective oversight throughout the collaboration - including monitoring parameters, change control, and regular vendor reviews (up to audit and requalification).
By the end, you will have a clear framework and concrete steps to strengthen compliance and reliability in day-to-day vendor management.
Your Benefit
- You get a clear decision logic for what to outsource in regulatory affairs.
- You learn a lean, risk-based approach to vendor selection and qualification.
- You can set up a governance system fast.
- You improve ongoing oversight and compliance via monitoring, change control and vendor reviews.
Programme
9:00 - 13:00 CET
09:00
09:15
Stephan Hütter
- Reasons for outsourcing
- When and what to outsource
- Pros and cons of outsourcing
- Global vs local RA outsourcing
10:15
Stephan Hütter
- Vendor selection & qualification
- Risk assessment & categorisation of outsourced activities
10:45
11:00
Stephan Hütter
- Setting up performance measurement & KPIs
- Governance structures
- Establishing a communication & escalation plan (regular governance meetings, reports, documentation)
- Budget monitoring & suitable tracking tools
- Systems & tools
11:45
Stephan Hütter
- Monitoring parameters
- Change control
- Regular vendor review, audit and requalification
12:15
Stephan Hütter
13:00
Introduction and technical warm-up
09:15
Foundations of Outsourcing in Regulatory Affairs
Foundations of Outsourcing in Regulatory Affairs
Stephan Hütter
- Reasons for outsourcing
- When and what to outsource
- Pros and cons of outsourcing
- Global vs local RA outsourcing
10:15
Step One: Vendor Selection and Risk Assessment
Step One: Vendor Selection and Risk Assessment
Stephan Hütter
- Vendor selection & qualification
- Risk assessment & categorisation of outsourced activities
Coffee break
11:00
Step Two: Set-up & Management of Outsourced Processes
Step Two: Set-up & Management of Outsourced Processes
Stephan Hütter
- Setting up performance measurement & KPIs
- Governance structures
- Establishing a communication & escalation plan (regular governance meetings, reports, documentation)
- Budget monitoring & suitable tracking tools
- Systems & tools
11:45
Step Three: Maintaining Oversight & Ongoing Compliance
Step Three: Maintaining Oversight & Ongoing Compliance
Stephan Hütter
- Monitoring parameters
- Change control
- Regular vendor review, audit and requalification
Final Discussion & Wrap-up
End
More Options
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Simply register for the seminar clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€290 + local VAT rather than €390 + local VAT).
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de