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Wednesday, June 29 • 2:00pm - 3:15pm
#339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-532-L05-P; CME 1.25; IACET 1.25; RN 1.25

The EU pharmacovigilance (PV) legislation has introduced significant changes to the presentation of clinical trial and postmarketing information. Data relevant to the benefit-risk balance of a product must be assessed against the existing standard of care, all of which evolve over time. Documents such as the risk management plan have become increasingly complex and writing them requires strong project management and regulatory skills. This session will describe the experience of managing PV documents and regulatory feedback in this new era, explain why writing for a lay audience is challenging and why it is an important challenge for the pharmaceutical industry to embrace, and will illustrate the challenges of producing, managing, and dealing with evolving benefit-risk assessments with some concrete examples.

Learning Objectives

Describe how to manage the writing of EU-Risk Management Plans including possible challenges and hands-on solutions; Identify the importance of writing for the lay audience along with suggested approaches; Discuss synergies within the preparation of periodic safety documents including how to effectively use them with respect to continuous benefit-risk evaluation.


Sven Schirp


Periodic Reporting in Drug Safety: From Safety Updates to Continuous Benefit-Risk Evaluations
Leonardo Ebeling

The EU-Risk Management Plan from a Medical Writer’s Perspective
Sven Schirp

Writing the Lay Summary (Section VI) of Risk Management Plans: Why and How?
Lisa Chamberlain James, PhD


Sven Schirp

Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma GmbH & Co. KG
Sven Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and pharmacovigilance documents to global marketing applications. He is currently Head of Global Pharmacovilgilance Writing at Boehringer... Read More →

avatar for Lisa Chamberlain-James

Lisa Chamberlain-James

Senior Partner, Trilogy Writing &; Consulting, United Kingdom
Lisa Chamberlain James is a Senior Partner and Chief Executive Officer of Trilogy Writing & Consulting. Aside from management activities, she also leads client projects, with extensive experience in a variety of documents and a special interest in drug safety and patient information... Read More →

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm-Wrtg-MSL, Symposium