FORUM INSTITUT
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Curse RMP and PSUR in life-cycle management
RMP and PSUR in
life-cycle management:
An art, not a miracle
2020-03-26 2020-03-26 Maritim Hotel Godesberger Allee 53175 Bonn info.bon@maritim.de +49 228 8108-0 +49 228 8108-811

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

Insights into RMP and PSUR preparation, assessment and regulatory management

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
  • RMP management in the post-authorisation phase
  • 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

This distinguishes our event

100%
Overall impression: 100% of the participants’ feedback was very good or good. (November 2018)
100%
Course content: 100% of the participants’ feedback was very good or good. (November 2018)
90%
Practical benefit: 90% of the participants’ feedback was very good or good.
100%
100% of the participants say that the course met their expectations. (November 2018)

Aims and objectives

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

After completing the seminar, you will:
  • be able to understand and handle your RMP correctly according to the current guidelines;
  • be familiar with the tasks and duties of a QPPV in the lifecycle of a marketing authorisation;
  • know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer;
  • be able to handle EU assessment reports and understand their impact on RMPs and PSURs;
  • 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 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.
Your speakers
Dr. Martin Huber
-requested- Senior Expert Pharmacovigilance, Bonn, Germany

Dr. Sabine Jeck-Thole
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

Dr. Harriet Palissa
Senior Expert Pharmacovigilance, Bonn, Germany

Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, Germany


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Our international course portfolio

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses for the healthcare industry.

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Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you. Our list of abbreviations can be freely downloaded here.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 01.2019 - 12.2019) produced a result of 1.6 (where 1 is the highest grade and 6 the lowest).

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