RMP and PSUR in life-cycle management: An art, not a miracle
Insights into RMP and PSUR preparation, assessment and regulatory management
- 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
Aims and objectivesThis 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.
- Overview of EU regulatory requirements for pharmacovigilance documents
- Role of RMPs and PSURs and life-cycle alignment
- The RMP in the initial marketing authorisation application phase
- RMP requirements
- Regulatory handling of RMP updates and authority's perspective on GVP Module V revision 2
- Significant changes in RMPs and safety concerns
11:10 Coffee break
- Safety concerns and industry perspective on GVP Module V revision 2
- Impact of EU assessment reports on RMPs and PSURs
- Effective global management
- Strategic planning and project coordination
- Harmonisation of RMPs and PSURs
- RMP Harmonisation Project (HarP)
- Role of RMP and PSURs in the context of QPPV tasks and duties
- Interdisciplinary responsibilities
- Quality management aspects
15:15 Coffee break
- Principles, planning and preparation of educational material
- Practical exercise
- EU perspective on additional risk minimisation measures - evaluation of their effectiveness
17:00 Seminar ends
Senior Expert Pharmacovigilance German PRAC member
EU QPPV and Head Regional Pharmacovigilance; Sabine Jeck-Thole, MD is Boehringer Ingelheim’s (BI) European Qualified Person for Pharmacovigilance (QPPV) and Head Regional Pharmacovigilance. Sabine has joined BI in April 2013 as Head Risk Management, Therapeutic Area of Metabolism & Virology. Prior to joining BI Sabine was working as TA Safety Lead for immunology and transplant at Novartis Pharma in Basel / Switzerland. She started her carreer in pharmaceutical industry as drug safety physician at Solvay Pharmaceuticals in Hannover/Germany. She has more than 15 years of research and clinical experience in anesthesia and intensive care and is a certified member of the German Board of Anesthesia and Intensive Care Medicine. Sabine received her medical training at the University of Marburg/Germany and at Medical Schools in London/UK.
Senior Expert Pharmacovigilance
Senior Pharmacovigilance Writer; Tiziana von Bruchhausen specialised over the last 10 years in pharmacovigilance and gained extensive hands-on experience with the EU Pharma Package. She worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies, covering various roles in a contract research organization and as a freelance writer. She is currently working as a senior pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on RMPs, PSURs and their assessment reports. Tiziana is an active volunteer at the European Medical Writers Association (EMWA), where she chairs the Pharmacovigilance Special Interest Group Committee. She was Vice President of EMWA in 2017 and has taken over the Presidency in May 2018.
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