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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
ICH PRODUCTS: 70 Guidelines on technical Requirements	Safety - 15 Guidelines Quality - 24 Guidelines Efficacy - 22 Guidelines Multidisciplinary - 9 Guidelines
The OVERACHING BODY of the association, composed of all members that take decisions, regarding articles of association, rules of procedure, admission of new members, adoption of ICH guidelines, etc	Assembly
The BODY THAT OVERSEES OPERATIONAL ASPECTS of the association on behalf of all members, including administrative and financial matters and oversight of the WG	Management Committee
DECISION MAKING IN ICH Management Committee provides:	RECOMMENDATION and SELECTION of new topics for harmonisation as well as on the adoption, withdrawal or amendments of ICH Guidelines
DECISION MAKING IN ICH Assembly takes decisions:	1 By consensus 2 If consensus is absent, vote in accordance with Articles of Association, where only REGULATORY MEMBERS have the right to vote
ICH Observers (Eligibility Criteria)	1 Limited eligibility criteria for new observers 2 No duties Imposed 3 Right of Observers: - Attend ICH Meetings, but no right to vote or appoint experts in WG - Standing Observers maintain right to appoint experts in Wgs
Steps in the ICH Process for Guideline Development	Step 1 - Consensus Building Step 2 - a. ICH Parties consensus on Technical Document b. Draft guideline adoption by regulators - Endorsement by A. assembly, B. regulators Step 3 - Regulatory consultation and discussion - Sign-off by regulatory topic leaders Step 4 - Adoption of an ICH Harmonised Guideline - Adoption by regulators Step 5 - Implementation
FOUR ICH GUIDELINES:	1 Quality Guidelines 2 Safety Guidelines 3 Efficacy Guidelines 4 Multidisciplinary Guidelines
Harmonisation achievements in this area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.	Quality Guidelines
ICH has produced a comprehensive set of guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT Interval prolongation liability: the single most important cause of drug withdrawals in recent years	Safety Guidelines
The work carried out by ICH under this heading is concerned with a design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.	Efficacy Guidelines
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronics Standards for the Transfer of Regulatory Information (ESTRI)	Multidisciplinary Guidelines