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The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 4 of the ICH Process in November 2012 and now enters the implementation period (Step 5).
The ICH S10 Guideline on Photosafety Evaluation of Pharmaceuticals reached Step 2 of the ICH Process in November 2012 and now enters the consultation period (Step 3).
In November 2012, the SC endorsed the revision of both the S1 Concept Paper and Business Plan to provide clarification concerning how the prospective data gathering period should be integrated in the normal ICH Step process.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in San Diego, California, USA on November 10-15, 2012.
“ICH makes progress on ongoing reform and adopts Guidelines for safety reporting”.
The MedDRA Management Board met in San Diego, CA, USA on 10-11 November 2012.
For Eighth Year in a Row, No Increase in MedDRA Subscription Rates.
In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.