2022-03-23 2022-03-23 , Online Online, 1.090,- € zzgl. MwSt. Dr. Martin Huber https://www.forum-institut.de/seminar/22032052-rmp-and-psur-in-life-cycle-management-an-art-not-a-miracle/referenten/22/22_03/22032052-online-course-rmp-and-psur-in-life-cycle-management_huber-martin.jpg RMP and PSUR in life-cycle management: An art, not a miracle

Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.

Topics
  • Role of RMP and PSUR and life cycle alignment
  • Insights in pharmacovigilance writing and QPPV oversight
  • Impact of EU assessment reports on RMPs and PSURs
  • Effective global management and harmonisation of RMPs and PSURs
  • Additional risk minimisation measures
Aims and objectives
This seminar provides insights in particular into RMP and PSUR preparation, assessment and regulatory management.

After completing the online seminar, you will
  • be familiar with the pharmacovigilance requirements in the life cycle of a medicinal product,
  • understand how safety concerns evolve in the life cycle and impact RMPs and PSURs,
  • be able to handle EU assessment reports and understand their impact on RMPs and PSURs,
  • know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer,
  • be familiar with the tasks and duties of a QPPV in the life cycle of a marketing authorization and
  • have a good understanding of the planning, preparation and management of additional risk minimisation measures.

Insights into the global management of pharmacovigilance documents round off this seminar.
Who should attend

This online seminar is intended for those working in the pharmaceutical industry already having profound knowledge of pharmacovigilance writing (with a focus on PSUR and RMP). QPPVs and people responsible for national pharmacovigilance are also invited to join the intensive discussion.

Online-Course RMP and PSUR in life-cycle management

RMP and PSUR in life-cycle management: An art, not a miracle

Benefits
  • Interactive online format
  • Take away practical hints and tips
  • Ask the experts!
  • We are following the IMI quality criteria

Webcode 22032052

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Termin

23.03.2022

23.03.2022

Zeitraum

09:00-17:00 online seminarYou may di...

09:00-17:00 online seminar
You may dial in 30 min. before the session
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

Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.

Topics
  • Role of RMP and PSUR and life cycle alignment
  • Insights in pharmacovigilance writing and QPPV oversight
  • Impact of EU assessment reports on RMPs and PSURs
  • Effective global management and harmonisation of RMPs and PSURs
  • Additional risk minimisation measures
Aims and objectives

This seminar provides insights in particular into RMP and PSUR preparation, assessment and regulatory management.

After completing the online seminar, you will

  • be familiar with the pharmacovigilance requirements in the life cycle of a medicinal product,
  • understand how safety concerns evolve in the life cycle and impact RMPs and PSURs,
  • be able to handle EU assessment reports and understand their impact on RMPs and PSURs,
  • know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer,
  • be familiar with the tasks and duties of a QPPV in the life cycle of a marketing authorization and
  • have a good understanding of the planning, preparation and management of additional risk minimisation measures.

Insights into the global management of pharmacovigilance documents round off this seminar.

Who should attend

This online seminar is intended for those working in the pharmaceutical industry already having profound knowledge of pharmacovigilance writing (with a focus on PSUR and RMP). QPPVs and people responsible for national pharmacovigilance are also invited to join the intensive discussion.

Detailed programme

09:00-17:00 online seminar
You may dial in 30 min. before the session
The times for breaks at online seminars are scheduled individually.

09:00

Introduction & Technical warm-up

09:10

Dr Tiziana von Bruchhausen

Regulatory activities in medical writing within medicinal product's lifecycle
  • Overview of EU regulatory requirements for pharmacovigilance documents
  • Role of RMPs and PSURs and life-cycle alignment

09:35

Dr Tiziana von Bruchhausen, Dr Martin Huber

Essentials to fix safety concerns in the RMP
  • RMP requirements
  • Authority's perspective on GVP Module V revision 2
  • Significant changes in RMPs and safety concerns
  • Industry perspective on GVP Module V revision 2
  • How guidance evolves along with accumulation of experience

10:15

Dr Sabine Jeck-Thole, Dr Martin Huber

Class discussion: What means "important" in the context of RMP risks? Revision of the list of safety concerns

10:55 Coffee break


11:15

Dr Tiziana von Bruchhausen, Dr Martin Huber

Specific guidance considerations with regard to RMP and PSUR of C19 vaccines

11:45

Dr Harriet Palissa

Focus of RMPs and PSURs
  • Timetables within the centralized procedure
  • RMP Harmonisation Project (HarP) with regards to DC-MRP Procedures

12:15

Dr Tiziana von Bruchhausen, Dr Sabine Jeck-Thole

Regulatory aspects of RMP and PSUR assessment
  • Impact of EU assessment reports on RMPs and PSURs: possible requests from final assessment reports; possible outcomes?
  • Harmonisation: vision or reality?

12:45

Dr Tiziana von Bruchhausen

RMPs and PSURs: Global management
  • Effective global management
  • Strategic planning and project coordination

12:55 Lunch break


14:10

Dr Sabine Jeck-Thole

Global PV activities: QPPV oversight
  • Role of RMP and PSURs in the context of QPPV tasks and duties
  • Interdisciplinary responsibilities
  • Quality management aspects

14:40 Coffee break


15:00

Dr Harriet Palissa, Dr Martin Huber

Additional risk minimisation measures (Focus on Educational materials)
  • EU perspective on additional risk minimisation measures - evaluation of their effectiveness
  • National implementation of Educational Materials in Germany

16:00

Dr Sabine Jeck-Thole

Practical exercise: Planning, preparation and implementation (incl. tracking) of additional risk minimization measures (e.g. educational material and DHPC)

16:40

What you have always wanted to ask

17:00 Seminar ends


Questions?

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 to s.wittemann@forum-institut.de

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good. (March 2020)

Course content: 100% of the participants’ feedback was very good or good. (March 2020)

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Go forward

Technical requirements

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

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Technical requirements
List of abbreviations

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

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Abbreviations, Glossary
Quality guaranteed!

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

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More on our quality criteria

Testimonials

Comments of participants (March 2020)
Since I am relatively new to the field, I wanted to learn more about RMP and PSUR life cycle management in general. I learned many things that I can use for my daily work. The seminar met my expectations.


My expectations were to have an open discussion on these matters and to check if we, as a company, are aligned with the other companies. these were fully met.


My initial expectations were about the identification of the important safety concerns according to the new GVP module V rev.2 and the identification of the additional PV activities and their possible effectiveness measures. All topics were discussed with a high level of detail.


The interaction between speakers and the content; was very lively.


The great interactions.

This is what participants in (November 2018) liked most about the event.
Topics, interactive presentations.