2024-04-22 2024-04-22 , online online, 1,190 € plus tax Dr. Martin Huber https://forum-institut.com/seminar/24112051-rmp-and-psur-in-lifecycle-management-an-art-not-a-miracle/referenten/24/24_11/24112051-course-rmp-and-psur-in-life-cycle-management_huber-martin.jpg RMP and PSUR in lifecycle management: An art, not a miracle

Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!

Topics
  • The role of RMP and PSUR in the drug lifecycle
  • Writing pharmacovigilance documents
  • QPPV oversight
  • Impact of EU assessment reports on RMPs and PSURs
  • Effective global management and harmonisation of RMPs and PSURs
  • Additional risk minimisation measures
  • If already published: GVP-Moduls XVI (Rev 3)


Who should attend
This course will be conducted in English.

This online seminar is aimed at pharmaceutical professionals who already have a good understanding of PSUR and RMP and would like to deepen, broaden, and update their knowledge. The course is suitable for both global and local PV functions.

More than 3 years' pharmacovigilance experience or previous attendance at an RMP and PSUR seminar is recommended.
Aims and objectives
This seminar deepens your knowledge in RMP and PSUR preparation, assessment and regulatory management.

The update of "GVP Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators" is expected in summer 2024. The FORUM Institute and our speakers guarantee that we will incorporate all updates into the training in an understandable way!

By attending this seminar, you will refresh your knowledge of the current European guidelines according to EMA Modules V and XVI. You will also learn new aspects of safety concerns and best practices for additional risk minimisation measures.

Take a look at pharmacovigilance documents from a QPPV perspective and benefit from our speakers' many years of experience with global authorities or in writing and harmonising RMP and PSUR!
Your benefit

After completing the online seminar, you will

  • understand how safety concerns evolve through the lifecycle and impact RMPs and PSURs.
  • know how to deal with EU assessment reports and understand their impact on RMPs and PSURs.
  • have mastered tips and tricks for strategic global management and be able to coordinate harmonisation and writing projects.
  • know how to plan, prepare and implement additional risk minimisation measures.

Course RMP and PSUR in life-cycle management

RMP and PSUR in lifecycle management: An art, not a miracle

The advanced course in Risk Management

Benefits
  • RMP and PSUR for PV experts
  • Interactive and hands-on online format
  • Experts with different professional backgrounds
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 24112051

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

06/11/2024

06/11/2024

Period

09:00-17:00 CET
You may dial in 30 min before the session

09:00-17:00 CET
You may dial in 30 min before the session
Venue

online

online

Fee
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!

Topics

  • The role of RMP and PSUR in the drug lifecycle
  • Writing pharmacovigilance documents
  • QPPV oversight
  • Impact of EU assessment reports on RMPs and PSURs
  • Effective global management and harmonisation of RMPs and PSURs
  • Additional risk minimisation measures
  • If already published: GVP-Moduls XVI (Rev 3)


Who should attend
This course will be conducted in English.

This online seminar is aimed at pharmaceutical professionals who already have a good understanding of PSUR and RMP and would like to deepen, broaden, and update their knowledge. The course is suitable for both global and local PV functions.

More than 3 years' pharmacovigilance experience or previous attendance at an RMP and PSUR seminar is recommended.

Aims and objectives

This seminar deepens your knowledge in RMP and PSUR preparation, assessment and regulatory management.

The update of "GVP Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators" is expected in summer 2024. The FORUM Institute and our speakers guarantee that we will incorporate all updates into the training in an understandable way!

By attending this seminar, you will refresh your knowledge of the current European guidelines according to EMA Modules V and XVI. You will also learn new aspects of safety concerns and best practices for additional risk minimisation measures.

Take a look at pharmacovigilance documents from a QPPV perspective and benefit from our speakers' many years of experience with global authorities or in writing and harmonising RMP and PSUR!

Your benefit

After completing the online seminar, you will

  • understand how safety concerns evolve through the lifecycle and impact RMPs and PSURs.
  • know how to deal with EU assessment reports and understand their impact on RMPs and PSURs.
  • have mastered tips and tricks for strategic global management and be able to coordinate harmonisation and writing projects.
  • know how to plan, prepare and implement additional risk minimisation measures.

Detailed programme

09:00-17:00 CET
You may dial in 30 min before the session

08:45

Technical warm-up
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00

Welcome and introduction

09:15

Dr Tiziana von Bruchhausen

Regulatory activities in medical writing within medicinal product's lifecycle
  • Overview of EU regulatory requirements for pharmacovigilance documents
  • Role of pharmacovigilance documents in the lifecycle

09:45

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

10:30 Coffee break


10:45

Dr Tiziana von Bruchhausen, Dr Martin Huber

Cross-link between different documents about "important" (PBRER/Clinical Overview)

11:15

Anika Staack

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

11:45

Dr Martin Huber

RMP harmonisation
  • The HaRP project

12:15 Lunch break


13:15

Dr Tiziana von Bruchhausen

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

13:45

Anika Staack

Global regulatory aspects of RMP and PSUR assessment
  • Examples of feedback from some global authorities (FDA, EMA, China, SwissMedic) to RMPs and PSURs/PBRERs

14:15

Anika Staack

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

15:00 Coffee break


15:15

Dr Martin Huber

Additional risk minimization measures
  • EU perspective on regulatory requirements
  • Effectiveness evaluation

16:00

Anika Staack

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

16:45

All speakers

What you have always wanted to ask

17:00 Seminar ends


Further information

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.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

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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
List of abbreviations

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

Details
Abbreviations, Glossary
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality

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.