Publication | March 2016
The fourth edition of the Life Sciences Law Review provides an overview of legal issues of interest to pharmaceutical, biotechnology and medical device companies in 30 jurisdictions. As before, each chapter contains information on legal requirements relating to the key stages in the life cycle of a regulated product, from discovery, through the clinical development process, registration, manufacturing and promotion, plus other issues of special interest, such as pricing and reimbursement, special liability regimes, competition and commercial transactions in the context of the medical products business. Each of the chapters has been prepared by a recognised expert in the relevant jurisdiction, and the resulting work product will assist industry lawyers, regulatory affairs staff and others who need to have an understanding of the issues in each major market.
A level of resignation accompanies talk of the data sharing legislation to be introduced to the Commonwealth Parliament later this year. For some Commonwealth agency staff, it’s the result of exposure to the day-to-day reality of agency data management.
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