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MedDRA and pharmacovigilance: A regulatory perspective Charlotte Goldsmith 16th April 2018 Signal Management Coordinator Contents • How the MHRA uses MedDRA • ADR reporting…
5th DIA China Annual Meeting – Patient Safety - A Sustained Focus from Scientific Ideas to Innovative Medicines May 12-15, 2013 Beijing, China Applying MedDRA® in Clinical…
MedDRA - International standard for coding safety information International Pharmacovigilance Conference Moscow Russia 10 October 2018 Anna Zhao-Wong MD PhD MedDRA MSSO Where…
MedDRA - Terminologies Coding Dr Anamika Dutta Medical Officer MedDRA MSSO 6th Asia Pacific Pharmacovigilance Training Course Feb 26th 2020 Disclaimer and Copyright Notice…
Slide 1„Ensuring Regulatory and Pharmacovigilance Compliance“ „Ensuring Regulatory and Pharmacovigilance Compliance“ Slide 2 „Ensuring Regulatory and Pharmacovigilance…
Slide 1„Ensuring Regulatory and Pharmacovigilance Compliance“ „Ensuring Regulatory and Pharmacovigilance Compliance“ Slide 2 „Ensuring Regulatory and Pharmacovigilance…
Farmakovijilans ve MedDRA Pharmacovigilance and MedDRA FARMAKOVİJİLANS ve FARMAKOVİJİLANS UYGULAMALARI 23-24 EKİM 2003 Dr. Tomás Moraleda Agenda 1. What is MedDRA?…
9/24/2017 1 Medical Dictionary for Regulatory Activities (MedDRA) Global Summit on Regulatory Science (GSRS) Brasilia, Brazil 19 September 2017 Anna Zhao-Wong, MD, PhD @…
WHO Meeting Dubrovnik Croatia October 30 2011 Heather Morrison Marketed Health Products Directorate Health Canada MedDRA an ICH Product A Regulator’s Experience Part Two…
EMA1752342019 Inspections Human Medicines Pharmacovigilance Committees Division Important medical event terms list MedDRA version 220 MedDRA Code PT Name SOC Name 10082297…
MedDRA® TERM SELECTION: POINTS TO CONSIDER Release 3.2 Based on MedDRA version 6.1 ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactions / Adverse Events…
MedDRA ® DATA RETRIEVAL AND PRESENTATION: POINTS TO CONSIDER ICH-Endorsed Guide for MedDRA Users on Data Output Release 317 Based on MedDRA Version 220 1 March 2019 Disclaimer…
9 Regulatory Aspects of Pharmacovigilance B. D. C. Arnold Introduction Pharmaceutical companies have a responsibility to make the use of their medicines as effective and…
© 2011 ICH 1 MedDRA in pharmacovigilance ‐ industry perspective SFDA‐ICH MedDRA Workshop Beijing 13‐14 May 2011 Christina Winter MD FFPM Medical director…
MedDRA® TERM SELECTION: POINTS TO CONSIDER ICH-Endorsed Guide for MedDRA Users Release 419 Based on MedDRA Version 230 1 March 2020 Disclaimer and Copyright Notice This…
MedDRA Labeling Groupings MLGs: A Harmonised Approach to Safety Communication CIOMS MLG Exploratory Team International Society of Pharmacovigilance 18th Annual Meeting Geneva…
MedDRA Coding Basics MedDRA® trademark is owned by IFPMA on behalf of ICH MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical…
International Lung Cancer Consortium Information Research SoDr 1667 Roche Pharma_Layout 1 28.08.13 14:48 Seite 1 Volume 90, November 2015, Pages 267–273 e-print Anti-angiogenic-specific…
MedDRA® TERM SELECTION: POINTS TO CONSIDER ICH-Endorsed Guide for MedDRA Users Release 417 Based on MedDRA Version 220 1 March 2019 Disclaimer and Copyright Notice This…
MedDRA® TERM SELECTION: POINTS TO CONSIDER ICH-Endorsed Guide for MedDRA Users Release 4.16 Based on MedDRA Version 21.1 1 September 2018 Disclaimer and Copyright Notice…