February 2010 Dr Carolyn Tucek-Szabo recently published an article on First in Man clinical trials in Australia in the Association of Regulatory and Clinical Scientists (ARCS) monthly journal in the October issue 2009. This article was based on a session held at the ARCS 18th Annual Scientific Congress held in Sydney, Australia in 2009. Please find the article here. February 2010 May Ling Chan recently attended the first Partnerships in Clinical Trials Asia Pacific conference and contributed a conference report which has been published recently on actmagazine.com. Her take on the conference and the pros and cons of including the Asia-Pacific region in global clinical trial programs are also featured in a blog by the same magazine. Please click on the article and blog to read more. January 2010 Dr. Emmanuelle Voisin was recently interviewed by Vivek Roychowdhury from ExpressPharma about building an affordable, innovative drug development chain, from discovery to market with the skilled people & partners of India. To read more about this insightful interview, please follow this link. December 2009 The regulation of medicines and medical devices in Australia is set for a major transition in 2010. With in vitro diagnostics to be regulated as a subset of medical devices in line with the Global Harmonisation Task Force, a risk based regulatory framework for cell and tissue therapies, and the Australian regulatory authority’s (TGA, Therapeutic Goods Administration) ongoing business process reform project, the regulation of medicinal products is further aligning itself with the European drug and device regulatory frameworks. 2010 will be the year of e-CTD and the AUSPAR: dossiers for new medicines will be increasingly submitted to the TGA in electronic format, and the AUSPAR (similar to the European Public Assessment Report) will be standard. Sponsors will also need to plan and negotiate the TGA’s more formal pre-submission process. With a proven track record in Europe, well established NESS/e-CTD solution services, and an experienced local Australian office, Voisin Consulting continues to be well placed to assist our clients in bringing their products to the Australian market in the most efficient and cost-effective manner. For further information please contact the Australian team. December 2009 The European Medicines Agency will have a new look and will no longer use the acronym “EMEA”. In an overhaul of its corporate identity, the visual appearance and importantly, the website and email addresses will change on 8 December 2009. From that date onwards, the address of the public website will be www.ema.europa.eu and e-mail addresses will take the form name.surname@ema.europa.eu. For further information, please see the attached press release.