Dr. Judy Harrison is the Chief Medical Officer of the MedDRA MSSO with responsibility for overall medical strategy. She sits on the ICH M1 “Points to Consider" Working Group and is an MSSO representative on the ICH MedDRA Management Board. Dr. Harrison has a particular interest in teaching and has conducted face-to-face training courses for many hundreds of MedDRA users as well as delivering training via webinars and videocasts.
Dr. Harrison frequently speaks on MedDRA-related topics at DIA meetings and she has authored a number of journal articles on MedDRA. Dr. Harrison has over 25 years’ experience in clinical research and pharmacovigilance in the pharmaceutical industry including positions at Bayer in the UK and Schering-Plough Research Institute in the US. She established her own independent consulting company, Harrison Clinical Consulting, in 1999 and joined the MSSO in 2004.
She is currently the chair of a Data Safety Monitoring Board for the US National Institutes of Health. Dr. Harrison is on the faculty as an Adjunct Assistant Professor at Rutgers, The State University of New Jersey where she is an instructor for the Master’s in Clinical Trial Sciences program.
Dr. Harrison received her undergraduate degree from the University of Cambridge and her medical degree from the University of Oxford.
Patrick Revelle is the Director of the MedDRA Maintenance and Support Services Organization (MSSO). Mr. Revelle is responsible for the maintenance, delivery and support services for MedDRA around the world. Mr. Revelle reports to a Management Board made up of regulators and industry representatives from Japan, Europe and the United States. Mr. Revelle has been with the MedDRA MSSO project since its inception in November 1998 and has served as the Program Manager since November 2003.
Mr. Revelle’s formal education is in Computer Science (B.S. Loyola College, 1982) and worked for several years developing and implementing software systems for the US Department of Defense prior to joining the MSSO.
David W. Richardson, M.D. is an independent consultant to the MedDRA MSSO. He is involved in conducting face-to-face courses in the US as well as online Webinars. In addition, he provides assistance on other terminology maintenance and development projects.
Dr. Richardson has a wealth of experience in clinical and pharmaceutical medicine. In addition to his time spent as a practicing neurologist, he has had a long career in the pharmaceutical industry working in the areas of clinical research and drug safety/pharmacovigilance. Dr. Richardson has worked for several companies including Johnson & Johnson, Abbott Labs and Solvay Pharmaceuticals.
Dr. Richardson is an experienced teacher and presenter and he has held faculty appointments at several prestigious institutions including the University of Pennsylvania. His additional interests include medical writing, course development and health information technology.
Dr. Richardson has a bachelor's degree in biology from Harvard University and a medical degree (M.D.) from the University of Pennsylvania. He completed residency and fellowship training in neurology at the University of Pennsylvania as well. Dr. Richardson is a licensed physician and is also board-certified in his specialty of adult neurology.
Dr. Anna Zhao-Wong is the Deputy Director and the Manager of Terminology Development and Services of the Maintenance and Support Services Organization (MSSO). She has led MedDRA development projects, such as the expansion of medication error and medical device adverse event terms in MedDRA, and provides medical support of terminology maintenance. Additionally, as one of the MSSO trainers, Dr. Zhao-Wong has conducted face-to-face and webinar training courses for participants from regulatory authorities and the biopharmaceutical industry.
Dr. Zhao-Wong received her MD from Beijing Medical University and PhD from the Uniformed Services University of the Health Sciences. She joined the MSSO in the year 2000.
Dr. Zhao-Wong can conduct training classes in English and Mandarin Chinese.
Jane Knight works part-time for the MSSO as an Instructor and Clinical Associate. Jane delivers the range of MSSO courses and webinars, within Europe.
In her long experience working with MedDRA, Jane has converted legacy databases, established a centralised coding process for both Drug Safety and Clinical Data and has successfully overseen the outsourcing of coding activities to an offshore service provider. She currently maintains her coding skills up-to-date through part-time coding consultancy work
As an active member of the Association for Clinical Data Management (ACDM) and a member of their training committee, Jane founded the Coding & Dictionaries Special Interest Group which she chaired for 5 years. She has given presentations at a range of European conferences including ACDM, DIA, IIR and the MSSO MedDRA User Group. She was a guest speaker at the 2012 Beijing FDA Pharmacovigilance training.
Jane is a Registered General Nurse with an undergraduate degree in Social with Clinical Psychology and a Masters degree in Health Psychology from the University of Kent in the UK. She is currently studying for a Masters degree in Digital Education.
A graduate of the Autonoma University of Madrid with a Degree in Medicine and Surgery, Dr. Moraleda qualified as a General Practitioner and worked in different positions within the Spanish National Health Service for more than 6 years. After joining the pharmaceutical industry, Dr. Moraleda held different positions in several companies, working mostly in fields related to clinical research. He was the Medical Director of Andrómaco Laboratories and a General Manager for Quintiles in Spain. Dr. Moraleda has been an International Medical Officer in the MSSO since its inception, gaining wide expertise in the MedDRA terminology.
Dr. Moraleda can conduct training classes in English and Spanish.
Dr. Eva Rump started to work for the Maintenance and Support Services Organization (MSSO) back in 1999 as an International Medical Officer. One of her main responsibilities as a member of the maintenance team is to ensure medical accurateness and international acceptance of the content of the terminology. An additional area of her work is the development and integration of new concepts into MedDRA (e.g., medication errors, product quality terms, device related concepts, specific vaccination complications, and clinical effects of poisoning including chemical and biological agents). In addition to regulators and pharmaceutical companies, she communicates with academic and university institutions – mainly in Europe - to help to integrate MedDRA into their systems and convert data. In her over 10 years with the MSSO, she has conducted many on-site and open training courses for MedDRA subscribers including European regulators and academic institutions in both English and German, and has also presented webinar training sessions. Dr. Rump attends and speaks at European DIA meetings and she has authored and co-authored journal articles on MedDRA.
Dr. Rump began her career in pharmaceutical research in 1984 as a clinical investigator in a Phase I unit of a German-based contract research organisation. Following this experience, Dr. Rump worked at Innovex (which merged with Quintiles in 1998), where she headed up a group of up to 25 clinical in-house monitors in the Department of Biometrics, working in close cooperation with the Data Management and Statistics Department. Her final position at Quintiles was Group Manager of Data Management. In those positions, she gained a variety of experience with different coding tasks and dictionaries such as WHO-ART, WHO-DRL, COSTART, HARTS and ICD-9/10. One of her final projects at Quintiles was working with the MedDRA implementation group, and working on the task force group for Global Coding.
Since 2002, she has been a regular member of the CIOMS Working Group for Standardised MedDRA Queries (SMQs) and acts as the point of contact for the CIOMS/WHO Working Group for Adverse Events Following Immunisation. Dr. Rump received her professional license for Medicine from the Albert – Ludwig University Freiburg, Germany. She received her doctoral degree for basic research in the field of virology.
Dr. Rump can conduct training classes in English and German.
After qualifying as a general practitioner in Paris, France, Philippe Thouvay practiced medicine for over 20 years in a village in Southwest France and was an investigator for phase IV studies. He joined Roche, in the UK, as a Drug Safety physician in 1998 and was soon responsible for MedDRA global implementation in Drug Safety while maintaining reporting ongoing activities. Key tasks were:
- Legacy data conversion to MedDRA
- Conversion to MedDRA of all type of reports (over 200 in total) including MedWatch and CIOMS reports
- Training Pharmacovigilance staff worldwide
- MedDRA Versioning
- Labeling with MedDRA
Dr. Thouvay pursued his career with Amgen, in 2005, as Head of European Union Pharmacovigilance and later rejoined Roche as Head of Data Management Services in the UK where he was also responsible for the medical meaningfulness of the Roche corporate dictionary (maintenance of the synonym list matching to MedDRA).
He has presented on numerous occasions on MedDRA in Europe (IIR Conferences, MSSO MedDRA User Group meetings, Informal MedDRA User Group meetings, ACDM in the UK, Pharmacovigilance AMIPS/DMB in France) and the USA (DIA).
Member of the EFPIA MedDRA Task Force - 2001-2008
Member of the CIOMS Working Group for Standardised MedDRA Queries (SMQs), 2005-2006
Member of the MSSO Blue Ribbon Panel on the scope of MedDRA (2003) and on CTCAE to MedDRA mapping (2006)
Dr. Thouvay can conduct training classes in English and French.
User Comments on MSSO Training
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