Managing CMC for global accelerated marketing approvals

In an increasingly complex global regulatory environment, proper planning and where possible, timely engagement with Health Authorities have the potential for up front resolution of potential CMC review issues. Such Health Authority interactions may facilitate faster dossier review and subsequent marketing authorization approval. In this session, a case study of a global new marketing application will be presented. Additionally, a discussion will explore the challenges, including time and resources, associated with in-country testing, which many countries require for imported products. The IFPMA position on waiver of redundant in-country testing will be presented. Success in receiving complete or partial waiver of in-country testing can be achieved, provided it is properly justified and supported by quality systems and controls in place at all stages of the manufacturing and supply chain to assure that products remain fit for their intended use

On the Limitations of Neutrino Emissivity Formula of Iwamoto

The neutrino emissivity from two and three flavour quark matter is numerically calculated and compared with Iwamoto's formula. We find that the calculated emissivity is smaller than Iwamoto's result by orders of magnitude when $p_{f}(u)+p_{f}(e)-p_{f}(d(s))$ is comparable with the temperature. We attribute it to the severe restriction imposed by momentum conservation on the phase space integral. We obtain an alternate formula for the neutrino emissivity which is valid when the quarks and electrons are degenerate and $p_{f}(u)~+~p_{f}(e)~-~p_{f}(d(s))$ is large compared to the temperature.Comment: Latex Version 2.09, 15 pages, 5 postscript figures available upon request, preprint No. IP/BBSR/93-6