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The MedDRA Management Committee noted that 1 March 2019 marked the 20th anniversary of the first release of MedDRA, which now has over 5,700 subscribing organisations in over 125 countries using 12 language translations.
The International Council for Harmonisation (ICH) met in Amsterdam, the Netherlands from 1 – 6 June 2019. The meeting marked ICH’s largest biannual meeting to-date, bringing together almost 500 participants from ICH’s sixteen Members and twenty-eight Observers.
The International Council for Harmonisation (ICH) met in Amsterdam, the Netherlands from 1 – 6 June 2019. The meeting marked ICH’s largest biannual meeting to-date, bringing together almost 500 participants from ICH’s sixteen Members and twenty-eight Observers.
MedDRA celebrates its 20th Anniversary. The MedDRA Management Committee noted that 1 March 2019 marked the 20th anniversary of the first release of MedDRA.
The ICH E8(R1) draft Guideline on General Considerations for Clinical Studies reached Step 2b of the ICH Process in May 2019 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the Expert Working Group.
The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.
ICH is conducting a Call for Expression of Interest for ICH Training Associates with a view to exploring the possibility of contracting appropriate accredited non-profit training organisations/institutions.
In 2018 Lenita Lindström-Gommers (ICH Assembly Chair, EC, Europe) and Theresa Mullin (ICH Management Committee Chair, FDA, United States) authored an article regarding ICH’s organisational reforms published in Clinical Pharmacology & Therapeutics.