Jim Ackland has over 40 years experience in the manufacture, quality control, development and international regulatory requirements for vaccine products. This includes senior management positions in the manufacture, quality assurance and research and development at CSL Limited, Australia. From 1990 to 1999 he was Head of Regulatory Affairs for Vaccine Products at CSL Limited (Australia). From 1999 to 2005 he was Vice President/Senior Consultant for the Biologics Consulting Group (USA), an internationally recognized pharmaceutical regulatory consulting company. Jim is currently CEO of Global BioSolutions, an Australian company based in Melbourne Australia, which provides regulatory and product development advice and assistance to biotech companies. Jim has been involved in many vaccine development projects as the lead regulatory advisor/negotiator and has filed numerous successful clinical trial applications in the US (FDA IND applications), Europe (CT Applications) and in Australia (CTN/CTX applications).