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Topic: Risk Management

November 14, 2017 | London, UK Trilogy hosted a discussion on the main challenges on PBRERs and RMPs and reviewer insights, together with our speakers:
Risk Management Plans and Summary for the Lay Reader
July 12, 2016 | Frankfurt, Germany Trilogy hosted a discussion on every-day challenges involved in meeting the guideline on good pharmacovigilance practices (GVP), the challenge of writing and managing Risk...
16_Risk Management Plans_New challenges for a new era_Lisa Chamberlain James et al_TOPRA 11-6_Jun 2014_Thumbnail
Risk Management Plans – New challenges for a new era
The complexity of the new RMP, not least the summary for the lay reader, is challenging writers.
Author: Lisa Chamberlain James, Lambert A.J.M. Creuwels and Madhu Davies
Journal: TOPRA - Regulatory Rapporteur
Date: Vol.11, No.6, June 2014
15_Improving Transparency and Benefit-Risk Assessments with the New RMP_Julia Forjanic Klapproth & Lisa Chamberlain James_JCS 5-5_2013_Thumnail
Improving Transparency and Benefit/Risk Assessments with the New Risk Management Plan
Personalised health care - "shared decision-making" with patients relies on them being well informed.
Author: Julia Forjanic Klapproth and Lisa Chamberlain James
Journal: Journal for Clinical Studies
Date: Vol.5, No.5, 2013