S1B(R1) – Training on Testing for Carcinogenicity of Pharmaceuticals

Home / Guidelines & Products

S1B(R1) – Training on Testing for Carcinogenicity of Pharmaceuticals

Further to the ICH Management Committee’s endorsement of the S1B(R1) IWG Concept Paper in March 2024, the S1B(R1) IWG was established to share experiences regarding ongoing implementation efforts for the new S1B(R1) weight of evidence (WoE) approach for carcinogenicity assessments, to develop potential best practices, and to provide counsel to parties regarding implementation issues.

Further information can be found in the S1B(R1) IWG Concept Paper.

Endorsed Documents

S1B(R1) IWG Concept Paper

S1B(R1) Work Plan

Ongoing public consultations

No results found.

S1B(R1) Implementation Working Group

Rapporteur

Dr. Andrew GoodwinFDA, United States

Regulatory Chair

Dr. Christine SiezenEC, Europe

Experts

EC, EuropeDr. Karen Van Malderen

EFPIADr. Thomas Nolte

EFPIADr. John Vahle

FDA, United StatesDr. Calvin Lee Elmore

Health Canada, CanadaDr. Alisa Vespa

JPMADr. Kenjiro Tsubota

MHLW/PMDA, JapanDr. Jihei Nishimura

MHLW/PMDA, JapanDr. Kumiko Ogawa

MHLW/PMDA, JapanDr. Takeshi Toyoda

NMPA, ChinaDr. Tao Sun

PhRMADr. Jose Lebron

Swissmedic, SwitzerlandDr. Tania Cavaliero

TITCK, TürkiyeDr. Şilan Çatak

Rapporteur Supporter

Alternate

Dr. Geoffrey EbereHealth Canada, Canada

Dr. Elisabeth KlenkeSwissmedic, Switzerland

Dr. Volkan TümerTITCK, Türkiye

Related guidelines

Harmonised

S1C – Dose Selection for Carcinogenicity Studies of Pharmaceuticals

In Process

S1C – Dose Selection for Carcinogenicity Studies of Pharmaceuticals

Pre-harmonisation

S1C – Dose Selection for Carcinogenicity Studies of Pharmaceuticals

Harmonised

S1A – Need for Carcinogenicity Studies of Pharmaceuticals

In Process

S1A – Need for Carcinogenicity Studies of Pharmaceuticals

Pre-harmonisation

S1A – Need for Carcinogenicity Studies of Pharmaceuticals

Harmonised

S1B – Testing for Carcinogenicity of Pharmaceuticals

In Process

S1B – Testing for Carcinogenicity of Pharmaceuticals

Pre-harmonisation