Pharmacovigilance Inspection Readiness
Strategies for successful PV (remote) inspections in Germany, Europe and worldwide
- Be prepared for global on-site, remote, and hybrid GVP inspections
- Firsthand information from experts
- Officially certified to the ISO 9001 and ISO 21001 standards
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
This advanced one-day online course provides a practical framework for successfully managing pharmacovigilance inspections in Europe and globally, from long-term readiness planning through to CAPA follow-up.
Your speakers
Angela Hartmann
Senior Expert Pharmacovigilance, Darmstadt
Audit, Inspection, Deviation and CAPA Manager;
Ms Hartmann has many years of experience in drug safety in international pharmaceutical companies, including…
Your speaker
Angela Hartmann
Senior Expert Pharmacovigilance, Darmstadt
Audit, Inspection, Deviation and CAPA Manager;
Ms Hartmann has many years of experience in drug safety in international pharmaceutical companies, including case handling, process management, pharmacovigilance database management, global literature research, clinical trials, audits and inspections.
Per-Holger Sanden
Merck Healthcare KGaA
Inspection Management Lead
Per-Holger Sanden is an experienced and dedicated physician with extensive expertise in pharmaceutical quality assurance and process optimisation. Since…
Your speaker
Per-Holger Sanden
Merck Healthcare KGaA
Inspection Management Lead
Per-Holger Sanden is an experienced and dedicated physician with extensive expertise in pharmaceutical quality assurance and process optimisation. Since 2016, he has led Inspection Management at Merck Healthcare KGaA, coordinating over 160 inspection teams worldwide across GCP, GVP, and GLP. As a pragmatic troubleshooter, he combines in-depth knowledge with a passion for quality risk management and an interest in computer system validation.
Dr. Kimberley Sherwood
-requested-
Senior Expert Pharmacovigilance, Bonn
Deputy Head of Risk Assessment Procedures and Pharmacovigilance Inspections;
After completing her PhD in Pharmaceutical Microbiology, Dr Sherwood began…
Your speaker
Dr. Kimberley Sherwood
-requested-
Senior Expert Pharmacovigilance, Bonn
Deputy Head of Risk Assessment Procedures and Pharmacovigilance Inspections;
After completing her PhD in Pharmaceutical Microbiology, Dr Sherwood began her career as a scientific associate in the pharmaceutical industry in the fields of medical writing, regulatory affairs, and pharmacovigilance. Since 2007, she has been working for a national authority, where she is responsible for pharmacovigilance inspections. She is a member of the Paul Ehrlich Society for Chemotherapy (PEG), and member of the Pharmacovigilance Inspectors Working Group (PhV IWG).
What to Expect
- Regulatory framework, objectives, and inspection formats
- Governance, quality oversight, and strategic planning for GVP inspection readiness
- Preparing for on-site, remote and hybrid inspections
- People, processes, document management, communication and training
- Inspection findings, reports and CAPA follow-up
- Inspection expectations in Germany, the EU, and other global regions
Who Should Attend
This course will be conducted in English.
This online seminar is designed for experienced professionals working in pharmacovigilance, quality management and regulatory functions who contribute to the preparation or management of PV inspections.
It is particularly relevant for EU QPPVs, local QPPVs, Heads of Pharmacovigilance, PV Quality Managers, inspection-readiness leads and other professionals responsible for global or regional PV oversight.
Objective of the Event
Pharmacovigilance inspections test more than the existence of procedures. They test whether a company can demonstrate control of its PV system, explain its decisions and respond effectively when issues are identified.
This online course provides a structured, practical approach to inspection readiness across regions. You will explore regulatory expectations, planning strategies and common inspection challenges, including remote and hybrid inspection formats. A dedicated EU authority case study illustrates how inspection practice can translate regulatory requirements into demanding questions, document requests and findings.
After attending the course, you will be able to:
- develop and maintain a risk-based inspection-readiness plan.
- organise effective preparation for on-site, remote, and hybrid inspections.
- manage roles, communication and documentation during an inspection.
- respond constructively to findings and establish effective follow-up measures.
- adapt global preparation activities to local inspection expectations.
Your Benefit
This seminar helps you turn inspection readiness from a last-minute exercise into a sustainable part of your PV quality system.
You will gain practical ideas for preparing people, processes and documents, test elements of an inspection-readiness plan in a workshop; and discuss your questions with experts who bring authority and industry perspectives together.
This online course will:
- familiarise you with the regulatory framework, objectives and formats of on-site, remote, and hybrid pharmacovigilance inspections.
- enable you to develop and maintain a risk-based inspection-readiness plan.
- help you manage inspection findings and establish effective CAPA follow-up.
- provide you with practical insights into differing inspection expectations in Germany, Europe, and other global regions.
Programme
09:00-17:00 CE(S)T
You may dial in 30 min before the session
08:45 - 09:00
You are welcome to log in a little earlier to test the audio and camera before the event begins.
09:00
FORUM Institut
09:15
Dr Kimberley Sherwood
- Legal basis
- Inspection objectives
- Inspection types
- On-site vs remote vs hybrid inspections
09:45
Per-Holger Sanden
- Strategies for GVP inspection readiness: Long term and short term
- Long term strategy: Quality management and inspection readiness plan
- Short term strategy: Logistics, communication and training
- Preparation of a GVP inspection
- Remote inspection
- Post inspection activities
- Success factors
10:45 - 11:00
11:00
Per-Holger Sanden
11:45
Per-Holger Sanden, Angela Hartmann
12:15 - 13:00
13:00
Per-Holger Sanden, Angela Hartmann
13:30
Dr Kimberley Sherwood
- Communication with the companies
- Inspection plan and scope
- Which are the most important documents?
- Current developments: Inspection questionnaire and remote inspections
- Frequent findings
- Possible consequences for companies
14:30
Angela Hartmann, Per-Holger Sanden
- PV Inspections in Europe
- PV Inspections in North and Latin America
- PV Inspections in Africa and MENA
- PV Inspections in APAC
- Discussion round
15:45 - 16:00
16:00
Angela Hartmann
- Main inspection phase
- Communication pathways: Intern and with the inspector
- Post inspection activities: Report and CAPA management
16:30
All speakers
- On-site, remote, and hybrid inspections
- Differences across regions
- Your own questions
17:00
08:45 - 09:00
Technical warm-up
Technical warm-up
You are welcome to log in a little earlier to test the audio and camera before the event begins.
Welcome and introduction
09:15
Pharmacovigilance inspections - fundamentals
Pharmacovigilance inspections - fundamentals
Dr Kimberley Sherwood
- Legal basis
- Inspection objectives
- Inspection types
- On-site vs remote vs hybrid inspections
09:45
Strategic planning and preparation for GVP inspections
Strategic planning and preparation for GVP inspections
Per-Holger Sanden
- Strategies for GVP inspection readiness: Long term and short term
- Long term strategy: Quality management and inspection readiness plan
- Short term strategy: Logistics, communication and training
- Preparation of a GVP inspection
- Remote inspection
- Post inspection activities
- Success factors
Coffee break
Continuation: Strategic planning and preparation of a GVP inspection
Avoiding common inspection pitfalls
Lunch break
Workshop: Your inspection readiness plan
13:30
EU authority case study: Inspection practice in Germany
EU authority case study: Inspection practice in Germany
Dr Kimberley Sherwood
- Communication with the companies
- Inspection plan and scope
- Which are the most important documents?
- Current developments: Inspection questionnaire and remote inspections
- Frequent findings
- Possible consequences for companies
14:30
Global inspection perspectives: What changes across regions?
Global inspection perspectives: What changes across regions?
Angela Hartmann, Per-Holger Sanden
- PV Inspections in Europe
- PV Inspections in North and Latin America
- PV Inspections in Africa and MENA
- PV Inspections in APAC
- Discussion round
Coffee break
16:00
Inspection and follow-up
Inspection and follow-up
Angela Hartmann
- Main inspection phase
- Communication pathways: Intern and with the inspector
- Post inspection activities: Report and CAPA management
16:30
Panel discussion
Panel discussion
All speakers
- On-site, remote, and hybrid inspections
- Differences across regions
- Your own questions
Seminar ends
Downloads
Request the documents using our form.
Brochure: Qualification Course Head of Pharmacovigilance
Link list: Drug Safety Navigator
Brochure: Qualification Course Head of Pharmacovigilance
Further Informations
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.
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.
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.
Customer Testimonials
What satisfied participants say
Our Recommendations
Further Information
Checklist for Medical Writing in PV
Necessary PV documents, contents and a medical writing checklist as a short overview.
In-house seminars
Our programmes are also available for in-house training. Just contact us!
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de