Harmonization authorized representative

The International Conference on Harmonization (ICH), representing FDA, EU, and Japanese regulatory authorities, produced guidance in 2000 on the manufacmre of active pharmaceutical ingredients (APIs) that included computer validation expectations. Not too surprisingly, essential principles were unchanged compared to computer vahdation for fiitished dmg products. The key topics covered were ... 

Payne, 1990 Sacks and Noguera, 1991). All those authors used a spherical-harmonic expansion to represent tip wavefunctions in the gap region, which is a natural choice. The spherical-harmonic expansion is used extensively in solid-state physics as well as in quantum chemistry for describing and classifying electronic states. In problems without a magnetic field, the real spherical harmonics are preferred, as described in Appendix A. 

All the above-mentioned legal treatises apply to the European Economic Area (EEA this comprises the 27 EU member states plus Liechtenstein, Iceland, and Norway—Switzerland chose by referendum not to join the EEA, but has certain Swiss-EU bilateral agreements). Switzerland acts as the representative of the European Free Trade Association, which is an observer in the ICH (International Conference on Harmonization) process, accepts ICH guidelines, but is not part of the European Economic Area. There is a legal obligation for the Swiss competent authority, Swiss Agency for Therapeutic Products (Swissmedic), to take account of decisions/authorizations in other territories that have equivalent medicinal product control. 

We point out that similar analyses and results have been performed and obtained also by other authors [33, 35, 38 0]. The spectral lines at 86meV and 123 meV excitation energy in the theoretical spectrum correspond to excitation of the modes V6 and vi, respectively. The first spacing deviates from the harmonic frequency of mode V6 in Table 3 because of the JT effect, while the second coincides with that of mode vi because of the linear coupling scheme adopted. For higher excitation energies the lines represent an intricate mixture of the various modes because of the well-know nonseparability of modes in the multi-mode dynamical JT effect. Overall, the excitation of the various modes can be characterized as moderately weak. The total JT stabilization energy amounts to 930 cm and is dominated by the contribution of mode ve- The barrier to pseudorotation is of the order of 10 cm only, consistent with the fact that the theoretical spectrum of Fig. 3 is obtained within the LVC scheme (see Sect. 2.1 above). 

Six parties to ICH represent the regulatory bodies and research-based industry in the three regions, Europe, Japan, and the United States, where the vast majority of new medicines are currently developed. These Six Parties are directly involved in the decision making process and were selected as they represent the regulatory bodies and the research-based industry in the European Union, Japan, and the United States. However, the Conference, its preparations, and follow-up activities are conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonization can be utilized worldwide. The Six Parties are as follows ... 

The ICH was formed in 1989 (Secard International Conference on Harmonization, 1994 Worden, 1995). It provides a forum for discussions about the internationally varied technical requirements for product registration and identifies where modification and mutual acceptance of research and development procedures could lead to more economical use of resources. Ostensibly harmonizing only between the United States, the European Union and Japan, several other national regulatory authorities send representatives to these meetings, and the ICH lead is thus followed widely around the globe. 

---