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International Conference Steering Committee

Harmonisation activities are overseen by a steering committee comprising representatives of each of the six parties, together with observers from the WHO, the European Eree Trade Association (EFTA) and Canada. The Committee meet at least twice each year, with the location rotating between the three regions. The committee also organises major international conferences on harmonisation that are held every 2 years. [Pg.37]

ICH Steering Committee, 1997, ICH Harmonised Tripartite guideline, Impurities Guideline for Residual Solvents, Q3C. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. [Pg.81]

ICH Steering Committee 2002, International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Impurities in new drugs substances ICH Steering Committee, 1997. [Pg.212]

It was agreed, from the start, that the focus for discussions of tripartite harmonisation should be an international conference or series of conferences. The Steering Committee recognised the importance of ensuring that the process of harmonisation is carried out in an open and transparent manner and that ICH discussions and recommendations are presented in open forums. [Pg.553]

International Conference on Harmonization (ICH) Steering Committee (1994), ICH harmonized tripartite guideline, Stability testing of new drug substances and products, ICH, Geneva. [Pg.676]

International Steering Committee, Rare Earth and Actinide Chemistry Conferences (1986-1990)... [Pg.531]

The International Conference on Harmonisation differs from many other harmonization initiatives in that it has a recognized status and is backed by a commitment on the part of both industry and regulators, to facilitate greater harmonization of technical requirements in the three regions. Commitment to these objectives, set out in the Terms of Reference, was re-affirmed by the Steering Committee in a statement issued following the meeting held in Tokyo, October 1990. [Pg.760]

S. Ye J. D. Cohen, In Multinational Arabidopsis Steering Committee (MASC) 18th International Conference on Arabidopsis Research, Beijing, China, 2007. [Pg.102]

International Conference on Harmonisation Steering Committee. Revised Guidance on Impurities in new drug substances, Federal Register 68 (2003), 6924-6925. [Pg.676]

International Conference on Harmonisation, Steering Committee, Future of ICH— Revised 2000. ... [Pg.179]

In November 1991, in Brussels, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held. A new topic was proposed to, and accepted by, the ICH Steering Committee. This was the thorny issue of tripartite mutual acceptance of foreign data. It was assigned the prefix E5 (efficacy, fifth topic approved) but was to be one of the slowest to be resolved - as the reader by now will appreciate, slowly resolved because of its complexity, not... [Pg.241]

The Committee was informed by the Secretariat that WHO continued to be an observer to the International Conference on Harmonisation (ICH) process, steering committee and global cooperation group. It serves as a link between the ICH and non-ICH parties. Concern was raised about the future status of WHO in ICH due to the lack of resources in WHO. During discussion, the Committee expressed concerns about the universal applicability of the so-called global standards and recommended that attempts by ICH and WHO to reconcile these standards should continue. [Pg.5]

The Sixth International Conference on Harmonisation will take place in Japan in the last quarter of 2003. In the meantime, the next ICH Steering Committee meeting was held in Tokyo, Japan, in May 2001. The priority before that was continuing work on the implementation of the CTD along with the principles and work plan defined by the ICH Steering Committee . [Pg.645]

International Conference on Harmonisation Steering Committee. Photostability Testing of New Drug Substances and Products, Federal Register 62(95), 27115-27 (1996). [Pg.169]

Several new developments on QT/QTc prolongation assessment have occurred recently. The most important includes the publication of the new International Conference of Harmonisation (ICH), Step 4 guidance, issued on May 12, 2005 entitled The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. It contains relevant information obtained from the ICH Steering Committee, as well as information discussed at the Qctober 2003 Food and Drug Administration (FDA) and Drug Information Association (DIA)... [Pg.977]

The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. International consensus conference on atopic dermatitis II (ICCAD II) clinical update and current treatment strategies. Br J Dermatol 2003 148(Suppl 63) 3-10. [Pg.1791]

International Conference on Harmonization Steering Committee. Q3A(R2) Impurities in New Drug Substances (Revised Guideline), Federal Register, Vol, 68, No. 68, p. 6924-6925, 2003. [Pg.161]


See other pages where International Conference Steering Committee is mentioned: [Pg.333]    [Pg.333]    [Pg.39]    [Pg.342]    [Pg.342]    [Pg.559]    [Pg.222]    [Pg.84]    [Pg.7]    [Pg.48]    [Pg.964]    [Pg.2968]    [Pg.438]    [Pg.84]    [Pg.21]    [Pg.171]    [Pg.209]    [Pg.343]    [Pg.488]    [Pg.230]   
See also in sourсe #XX -- [ Pg.552 ]




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Steer

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