Second Workshop Announcement: Regulatory Review of Continuous ECGs

Tuesday 12 November 2013

Mortara Instrument initiated the expansion and upgrade of tools for submitting continuous ECG data to the ECG Warehouse in 2010. As part of this initiative, the FDA held a public meeting on March 12, 2012 to discuss changes in how continuous digital ECG data is gathered and submitted to the ECG Warehouse and new tools for visualizing the continuous, annotated ECG recordings. An extension of the Health Level-7 Annotated ECG standard data format was proposed for this purpose. The new data format is intended to facilitate electronic submission and sharing of ECG data from continuous recordings. 


Now that the ECG Warehouse stands ready to receive data in the proposed format, sponsors and ECG core laboratories are moving forward quickly to implement compliant solutions. As expected, through these implementation activities, several questions regarding the proper utilization of the continuous aECG Waveform Standard have surfaced. 


In order to provide answers to such implementation questions and other related issues, AMPS, LLC and Mortara Instrument, Inc. are organizing a workshop designed for representatives from sponsor organizations and ECG core laboratories who are responsible for compliance with the new Regulatory Review of Continuous ECGs.



This one day workshop will feature presentations about:


  • Why the FDA wants to review continuous ECG data
  • What is continuous ECG data, and how is it collected, analyzed, and managed
  • Clarify missions of various organizations, the data they collect, and the tools they use
  • A review of the HL7 aECG v1 Standard
  • Present changes in v2 to support continuous ECGs
  • ECG Warehouse v2: the new tools
  • Beyond ICH using aECG v2: examples from the CSRC white paper
  • Case Studies from industry leaders


Participants of the workshop will receive one free copy of the updated Mortara/AMPS xml Implementation Guide which will cover topics, including:


  • aECG v2: what's new?
  • How to submit continuous data
  • Usage of external files: for waveforms and annotations
  • Annotating Time Points and Analysis Windows
  • How to submit derived waveforms/measurements: as external files, as part of the XML
  • Examples: Beat-to-Beat Study and Extraction (ICH-E14) Study



Participants will also receive one complimentary individual lifetime license of the new AMPS Holter aECG viewer, the viewing module of the recently announced AMPS Continuous ECG Recording Suite (CER-S) a commercial value of $1,000.


The presenters will include:

  • Dr. Norman Stockbridge, Director of the Division of Cardiovascular and Renal Products in FDA's Center for Drug Evaluation and Research
  • Dr.Fabio Badilini, F.A.C.C. Chief Scientists of AMPS
  • Barry Brown, (Product Integration Manager) of Mortara Instrument
  • Dr Corina-Dana Dota, Business Area Leader for dECG systems and processes at AstraZeneca R&amp
  • Dr Robert Kleiman MD, Vice President Global Cardiology, ERT



Attendance will be strictly limited to encourage open exchange and discussion between presenters and participants.


Early bird registration fees (until Oct 31st) is $2,000 per attendee, $2,500 afterward. Additional attendees from the same companies will enjoy a fee of $500 per person. Given the high volume of inquires we are pleased to extend a discount registration to CSRC members at a rate of $1500 (additional registrants from the same organization enjoy a fee of $500 per person).; Additionally, representatives from Academic and Non-profit Research organizations will benefit a rate of $500 per person.


To reserve space and receive an invitation with workshop agenda, please contact: