Meet the MSSO Training Staff
Instructor: Judy Harrison, M.D.
Judy Harrison, M.D. is an independent consultant to the MedDRA Maintenance and Support Services Organization (MSSO) and her responsibilities as a Senior Medical Officer include terminology development, training, and providing general medical support. Dr. Harrison has conducted face-to-face training courses for many hundreds of MedDRA subscribers and has also presented webinar training sessions. She is a member of the ICH M1 "Points to Consider" Working Group.
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 20 years’ experience in clinical research and pharmacovigilance in the pharmaceutical industry including positions at Bayer in the U.K. and Schering-Plough in the U.S.
She is currently the chair of a Data Safety Monitoring Board for the National Institutes of Health. Dr. Harrison is on the faculty as an Adjunct Assistant Professor at the University of Medicine and Dentistry of New Jersey.
Dr. Harrison received her undergraduate degree from the University of Cambridge and her medical degree from the University of Oxford.
Instructor: Patricia Mozzicato, M.D.
Dr. Patricia Mozzicato’s career with MedDRA began in the late 1990s when, as a drug safety physician at Bristol-Myers Squibb, she helped their drug safety department switch from a legacy adverse event terminology to MedDRA. Part of her responsibilities at the time of the transition was to train all relevant BMS staff in MedDRA coding and analysis; this was before the MSSO had an established training program, making Dr. Mozzicato one of the very first MedDRA trainers.
While at BMS, she used MedDRA in routine pharmacoviglance activities, including individual case safety reports, PSURs, responses to regulatory queries, etc. Because of her early experience using MedDRA on live safety data, she was frequently invited to speak at DIA and other biopharmaceutical conferences to share her “lessons learned” with others who were still in transition to the new terminology.
In 2001, Dr. Mozzicato joined the MSSO and, within a few months, founded the MSSO Medical Team, consolidating all of the medical staff into a cohesive unit. She also developed several training courses and assisted many organizations – small and large – in their transition to MedDRA by guiding them through data conversion, helping establish coding conventions, and providing training.
Dr. Mozzicato is currently the Chief Medical Officer of the MSSO. She sits on the ICH M1 “Points to Consider” Working Group and on the CIOMS Working Group for Standardised MedDRA Queries (SMQs). She attends the ICH MedDRA Management Board meetings as an MSSO representative. She continues to provide MedDRA training and has a particular interest in training safety physicians about the terminology.
Dr. Mozzicato graduated from Tufts University School of Medicine and is Board Certified in Anatomic and Clinical Pathology and in Neuropathology.
Instructor: Ann Setser, BSN,MEd
Ann Setser, RN, is an independent consultant to the MedDRA MSSO working part-time on terminology development and training. At the National Cancer Institute Center for Cancer Research, Ann coordinated and supervised the execution of Phase 1 and 2 cancer treatment trials. She recently retired from the NCI where her responsibilities included oversight of the Common Terminology Criteria for Adverse Events (CTCAE), the Adverse Event Reporting System, and the development and presentation of educational materials to support both. She served as a domain expert for multiple working groups including Case Report Form Standardization; Structured Protocol Representation; Cancer Electronic Health Record, and other technology systems for data collection and analysis. In 2009 Ann was Project Officer for the NCI initiative to revise CTCAE to be fully MedDRA compliant.
Ann earned a Bachelor’s of Science, Nursing from Southwest Missouri University and a Master’s Degree in Education from Drury University, Springfield, MO.
Instructor: Anna Zhao-Wong, M.D. Ph.D
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 M.D. from Beijing Medical University and Ph.D. 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.
Instructor: Jane Knight, MSc, RGN
Jane Knight works part-time for the MSSO in addition to a full time position as Coding Group Manager in a global pharmaceutical company. As an MSSO instructor, Jane delivers the range of MSSO courses and webinars, within Europe.
During her 11 years’ experience working with MedDRA, Jane has converted legacy databases, established a centralized coding process for both Drug Safety and Clinical data and has successfully overseen the outsourcing of coding activities to an offshore service provider.
As an active member of the Association for Clinical Data Management, (ACDM) in the UK, 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 and is currently a member of the EFPIA MedDRA topic group.
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 Education.
Instructor: Tomás Moraleda, M.D.
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 for more than 12 years, gaining wide expertise in the MedDRA terminology.
Dr. Moraleda can conduct training classes in English and Spanish.
Instructor: Dr. Med. Eva-Beate Rump
Dr. Eva Rump started to work for the 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 is 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 organization. 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.
Instructor: Philippe Thouvay, M.D.
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 US (DIA, Washington, 2005).
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)
Over the past two years, he has delivered MedDRA training sessions in English and French on behalf of the MSSO to many European regulatory authorities and pharmaceutical industry personnel.
Dr. Thouvay can conduct training classes in English and French.