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ICH Association 2015 Annual Report (October 23 – December 31 2015) Prepared by the Management Committee With input from the ICH Secretariat INTRODUCTION The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established as a non-profit Association under Swiss law on October
ICH Q9(R1) Guideline 1 1 1 INTRODUCTION 2 Risk management principles are effectively utilized in many areas of business and government 3 including finance insurance occupational safety public health pharmacovigilance and by 4 agencies regulating these industries In the pharmaceutical sector the principles and framework
FINAL S11 Business Plan Endorsed: 10 November 2014 -2- 2 Planning What are the main deliverables? A Q&A document will be developed to clarify ICH Q11 selection principles and thereby achieve more consistency in the outcomes of starting material (and control) proposals The IWG will develop the Q&A based on information already available
Members: Founding Regulatory: EC Europe; MHLW/PMDA Japan; FDA United States Founding Industry: EFPIA; JPMA; PhRMA Standing Regulatory: Swissmedic Switzerland
ICH E9 (R1) Addendum: Statistical Principles for Clinical Trials Plans for December 2015 ICH Meeting • Progress towards finalization of the Step 1 Technical Document and progress the drafting of the technical appendix • Feedback from regional discussions both with statisticians and non?statisticians
2 ICH 20 YEARS OF SERVICE TO THE HYDROPOWER SECTOR I am proud to announce that 2015 marked the 20th anniversary of the International Centre for Hydropower (ICH) and another year in which ICH experienced growth ICH had courses in an all-time record of 16 countries in the course of the past year
as a foundation or resource document that is independent of yet supports other ICH Quality documents and complements existing quality practices requirements standards and guidelines within the pharmaceutical industry and regulatory environment
At Step 2 of the ICH Process a consensus draft text or guideline agreed by the appropriate ICH Expert Working Group is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation according to national or regional procedures Note:
The programme has four inter-related packages - Generate Your Business Idea (GYB) Start Your Business (SYB) Improve Your Business (IYB) and Expand Your Business (EYB) The ILO implements the programme using a three-tier structure comprising Master Trainers Trainers and the end beneficiaries – potential and existing entrepreneurs
ience Management System (ORMS 2015 1) and the WHO corporate risk management policy and process It also encompasses WHO responsibilities under the In - ternational Health Regulations 2 (2005) and other inter-national treaties as the United Nations lead agency for health and the Health Cluster and as a member of the
INTERAGENCY COMMISSION ON HOMELESSNESS ANNUAL REPORT 2015 3 Overview The Interagency Commission on Homelessness (ICH) was established by Montgomery County Council in 2014 and began its work in 2015 to promote efforts to prevent and end homelessness in Montgomery County
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