The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized international medical terminology that is used by regulatory authorities and the biopharmaceutical industry for regulatory communication and the evaluation of data pertaining to medicinal products for human use. This webinar will describe the features of MedDRA, and the relevant regulations concerning its use. In addition, it will provide an overview of coding with MedDRA and the applications of the terminology in data retrieval and analysis.
What You’ll Learn
o You will learn about the scope, structure, characteristics, and maintenance of MedDRA, and how it is used to share safety information about medical products worldwide
o You’ll learn about coding (data entry) with MedDRA and the MedDRA Term Selection: Points to Consider document
o You’ll learn about data analysis with MedDRA and the MedDRA Data Retrieval and Presentation: Points to Consider document, including the use of Standardised MedDRA Queries (SMQs) in safety signal detection
Who Should Attend
Clinical Data Managers (Beginner to Advanced)
Participation Benefits: This webinar will present a comprehensive overview of MedDRA and its applications as an international regulatory standard in all phases of the clinical development cycle.
Judy Harrison, MD
Chief Medical Officer, MedDRA MSSO
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 20 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 the 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.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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