2023-03-24 2023-03-24 , online online, 1,190 € plus tax Angela Hartmann https://www.forum-institut.com/seminar/23042050-pharmacovigilance-inspection-readiness/referenten/23/23_04/23042050-course-pharmacovigilance-inspection-readiness_hartmann-angela.jpg Pharmacovigilance Inspection Readiness

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.

Topics
  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GvP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
  • Differences in inspection strategies between Europe and other areas in the world


Who should attend
This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current pharmacovigilance inspection strategy in Europe and how to handle (remote) inspections successfully.
Aims and objectives
In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. This Online-Course will provide insights into the current (remote) pharmacovigilance inspection strategies. In addition, the pros and cons of remote inspections from the different perspectives (authorities vs. industry) will be discussed.

After attending the online-seminar you will:
  • be able to plan and prepare for pharmacovigilance inspections according to the different requirements and
  • improve how you process findings during and after the inspection.

You are cordially invited to participate in the moderated discussion round on the topic "Differences in inspection strategies between Europe and other areas in the world" and to enter into direct exchange with the speakers and the other participants.
Your benefit

This seminar enables you to professionally prepare your pharmacovigilance inspections in accordance with the applicable requirements.Discuss your questions with experts from authorities and industry and find answers to your questions. After the seminar you will understand the current pharmacovigilance inspection strategies and will be able to improve your processes accordingly.

Course Pharmacovigilance Inspection Readiness

Pharmacovigilance Inspection Readiness

Benefits
  • Be prepared for a (remote) GvP inspection
  • Firsthand information from the experts
  • We are following the IMI quality criteria

Webcode 23042050

Book now

JETZT Buchen
Speakers

Angela Hartmann

Senior Expert Pharmacovigilance, Darmstadt

Keine ausführliche englische Beschreibung vorhanden

Per-Holger Sanden

Merck Healthcare KGaA, Darmstadt, Germany

Inspection Management Lead

Dr. Kimberley Sherwood

Senior Expert Pharmacovigilance, Bonn, Germany

Senior Expert Pharmacovigilance

Everything at a glance

Appointment

24/04/2023

24/04/2023

Period

09.00-17:15 You may dial in 30 min. ...

09.00-17:15 You may dial in 30 min. before the session

09.00-17:15 You may dial in 30 min. before the session
Venue

online

online

Downloads
BROCHURE
BROCHURE
Fee

Event - 1,190 € plus tax
The fee includes a comprehensive online documentation including the possibility to download these documents and a certificate.

Event - 1,190 € plus tax
The fee includes a comprehensive online documentation including the possibility to download these documents and a certificate.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Dr. Myriam Friedel
Conference Manager

+49 6221 500-696
m.friedel@forum-institut.de

Details

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.

Topics
  • Fundamentals: regulations, occurrence, types and aims
  • Strategic planning and preparation for a (remote) GvP inspection
  • Report, findings and follow-up measures
  • Dos and don'ts, and factors of success
  • Differences in inspection strategies between Europe and other areas in the world


Who should attend
This online seminar will be of benefit to all those working in the pharmaceutical industry who need a deep understanding of the current pharmacovigilance inspection strategy in Europe and how to handle (remote) inspections successfully.
Aims and objectives

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. This Online-Course will provide insights into the current (remote) pharmacovigilance inspection strategies. In addition, the pros and cons of remote inspections from the different perspectives (authorities vs. industry) will be discussed.

After attending the online-seminar you will:

  • be able to plan and prepare for pharmacovigilance inspections according to the different requirements and
  • improve how you process findings during and after the inspection.

You are cordially invited to participate in the moderated discussion round on the topic "Differences in inspection strategies between Europe and other areas in the world" and to enter into direct exchange with the speakers and the other participants.

Your benefit

This seminar enables you to professionally prepare your pharmacovigilance inspections in accordance with the applicable requirements.Discuss your questions with experts from authorities and industry and find answers to your questions. After the seminar you will understand the current pharmacovigilance inspection strategies and will be able to improve your processes accordingly.

Detailed programme

09.00-17:15 You may dial in 30 min. before the session

09:00

Introduction round and technical warm up

09:15

Dr Kimberley Sherwood

GPvP inspections - Fundamentals
  • Legal basis
  • Inspection objectives
  • Inspection types

09:45

Per-Holger Sanden

Strategic planning and preparation of a GPvP Inspection
  • Planning and preparation for inspections
  • Guidance and quality documents
  • Inspection readiness plan
  • Importance of the PSMF
  • Quality management related to inspections
  • Roles of various stakeholders
  • Importance & composition of the team
  • How to prepare for inspection pitfalls

10:45 Coffee break


11:00

Per-Holger Sanden

Continuation: Strategic planning and preparation of a GPvP Inspection

11:45

Per-Holger Sanden, Angela Hartmann

How to prepare for inspection pitfalls

12:15 Lunch break


13:15

Dr Kimberley Sherwood

Pharmacovigilance inspections in Germany
  • Communication with the companies
  • Inspection plan and extent
  • Which are the most important documents?
  • Current developements
  • Typical findings
  • Consequences for companies

14:15

Per-Holger Sanden, Angela Hartmann

Differences in inspection strategies between Europe and other areas in the world
  • Discussion Round

15:45 Coffee break


16:00

Angela Hartmann

Inspection and follow-up
  • Communication with the inspector
  • The value of documentation and communication
  • Dos and don'ts, and factors of success
  • Report, findings and follow-up measures
  • Resolving inspection findings

16:30

All speakers

Remote Inspections - Lecture and panel discussion

17:15

Q&A Session

17:15 Seminar ends


Objectives

Objectives

  • Network with colleagues and meet regulators
  • Share experience and ideas in a neutral environment
  • Take away practial hints and tips
  • Excellent networking possibilities
  • This expertise will benefit your company

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good. (October 2018)

Course content: 100% of the participants’ feedback was very good or good. (October 2018)

Recommendations

Market Access & Pricing in Europe

Online seminar on Market Access & Pricing in Europe - this is how you can gain access as a pharmaceutical manufacturer!

27. - 28.04.2023, Online
Details

Crash Course: Medical Device Regulation

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

18.04.2023, Online
Details

Regulatory and GMP compliance in Eastern Europe

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)...

26. - 27.04.2023, Online
Details

CMC requirements in Latin America

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, Peru and CAMCAR (Central Americ...

19.04. - 24.05.2023, Online
Details

Variations in Europe

Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this onlin...

17. - 18.04.2023, Online
Details

Go forward

Checklist for Medical Writing in PV

Necessary PV documents, contents and a medical writing checklist as a short overview.

Details
Checklist for Medical Writing in PV
e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

Details
e-Learning
Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

Details
More on our quality criteria

Testimonials


Good & clear training in pharmacovigilance inspection readiness. Clear and very good speakers.

Bita Mangin

Sanofi Aventis Groupe, Paris


Practical examples related to PV inspection requests.


Sharing of examples from recent experiences.


Possibility to hear from other companies about their inspection experiences.