Adverse Event Terminology and Coding Working Group Sept 2017 - PowerPoint PPT Presentation

Adverse Event Terminology and Coding Working Group Sept 2017 Working Group Chair: H. Ishikawa Office of Standards and Guidelines Development Pharmaceuticals and Medical Devices Agency

Member list Australia: TGA Japan: PMDA Pamela Carter Hiroshi Ishikawa (Chair) Jorge Garcia Mari Shirotani Brazil: ANVISA Tsutomu Makino Maria Gloria Vicente Madoka Murakami Adriana Moufarrege Miho Sato Guilherme Antonio Marques Buss Takako Niwa Canada: Health Canada Kaori Ogawa Mary Raphael MHLW European Union: Miki Oota Jean-François Roche (EC) Noriaki Tokunaga Tony Sant (UK, MHRA) US: FDA Claudius Griesinger (EC/JRC) Nancy Pressly Graham Nash (UK, MHRA) Evan Jacobs Tim Raemaekers (EC/JRC) Singapore: HSA Robin Seidel (BfArM) Wong Woei Jiuang Russia: Roszdravnadzor AHWP: Aysylu Valeeva Sasikala Devi Thangavelu Elena Astapenko Gulnar Berkimbayeva 2 WHO: Anita Sands Nursultan Kalamov

Recent Meetings • Apr 5 th , 2017 16 th Teleconference • June 13 th – 16 th , 2017 4 th Face to Face meeting in Ispra, Italy • July 6 th , 2017 17 th Teleconference Coming Meetings • Oct 11 th , 2017 18 th Teleconference • Nov 28 th – Dec 1 st , 2017 5 th Face to Face meeting in Moscow, Russia 3

Adverse Event Reporting PATIENT DEVICE/COMPONENTS Medical Device Component Problem (Annex F) (Annex A) What was the problem Which components Patient at device level? were involved Problem (Annex E) What were the probable causes of the problem Cause What adverse Investigation events happened (Annex B-D) at patient level 4

Title: IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes Annex F Annex E Annex B - D Annex A Main Body: published on April 10 th in 2017 revised with the addition of Annexes Main Body B, C and D, and presented to MC as proposed final document (Edition 2) Annex A (Medical Device Problem): published with mapping on April 10 th in 2017 Annex B – D (Cause Investigation): presented to MC as proposed final document Annex E (Patient Problem): under discussion Annex F (Component): to be discussed after Annex E takes shape 5

Annex B-D: Cause Investigation Terms and Codes • Based on FDA terms and ISO terms • Consist of IMDRF codes, terms and definitions • 3 annexes Annex B: Type of Investigation (1 level) (e.g., Testing of Actual/Suspected Device, Testing of Device from Same Lot/Batch, Trend Analysis) Annex C: Investigation Findings (3 levels) (e.g., Biological Problem Identified, Cytotoxicity Problem Identified, Microbial Contamination) Annex D: Investigation Conclusion (2 levels) (e.g., Cause Traced to Device Design, Cause Traced to Manufacturing, Quality Control Deficiency) 6

Annex B: Type of Investigation 7

Annex C: Investigation Findings 8

Annex D: Investigation Conclusion 9

Annex E : Patient Problem • Based on FDA terms and refers to MedDRA • Consists of IMDRF codes, terms and definitions • JRC contributed the results of their own research on “the patient problem nomenclatures” at F2F in Ispra, and now organizing the structure of Annex E with mapping to MedDRA terms • Communicating with MedDRA, SNOMED and ICD closely 10

2017 Work Plan (as of July 2017) 2017 2018 Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep MC f2f MC TC MC f2f MC TC MC f2f Medical Device Problem MC approval WG f2f WG f2f FD Publish Moscow Cause Investigation MC approval FD Publish MC review Patient Problem Public Consultation MC review Components Public Consultation Maintenance phase Deadline

Thank you! 12