by clicking the arrows at the side of the page, or by using the toolbar.
by clicking anywhere on the page.
by dragging the page around when zoomed in.
by clicking anywhere on the page when zoomed in.
web sites or send emails by clicking on hyperlinks.
Email this page to a friend
Search this issue
Index - jump to page or section
Archive - view past issues
GRC Professional : GRC Spring 2012
24 GRC Professional • Spring 2012 IN DEPTH The quality of the data we need from clinical trials to secure licensing of our products means that demands of researchers are very high. synchronisation with European, US and other countries' drug regulators. Like other big pharmaceutical corporations with household brands, Boehringer Ingleheim's lengthy process of drug discover y, registration a nd marketing is co-ordinated globally, while product is manufactured at sites all over the world. "To fail to show our quality assurance in doing such expensive work could be severely damaging to our business," says Dr Creek. "There are huge amounts of money riding on research." Not only must he comply with internal practices, audits and inspections for clinical research programs he manages, but also with manufacturing specifications and toxicology tests for product stability and guarantee batch-to-batch consistency. "The quality of the data we need from clinical trials to secure licensing of our products means that demands of researchers are very high," he says. Supply restrictions Peter Sharpe, Eli Lilly's Ethics & Compliance Officer, uses the company's 'Ethical Interactions with External Parties' global policy, as well as MA's Code of Conduct, authorised by the Australian Competition and Consumer Commission, to make sure materials for healthcare professionals are appropriately prepared and reviewed. "Transparency of communications around all our practices is vital," he says, citing challenges and boundaries that come with the different entities of consumer (patient), Industry review highlights risks and challenges Global accounting and consultancy firm KPMG reviewed filings of the 34 largest pharmaceutical and other life sciences companies in the world to produce an overview of their risk and disclosure in April this year. It notes the report comes at a time when the industry is experiencing the long-expected patent cliff. Between 2011 and 2014 patent protections covering $US120 billion ($A115 billion) in sales globally is expected to be lost. The upshot is an expected impact on market growth rates when drug brands are replaced with their generic names. Other industry risks include pricing pressures, including those from emerging markets(albeit counter-balanced to a large degree by volume growth opportunities for mature markets), the economic crises, European austerity measures, and healthcare reform in the US. Key findings of the overview: • Rising legal, political, personnel and scientific risk, combined with a loss of trust are the key challenges for the industry. • Loss of trust comes from perception that pharmaceutical companies put their commercial goals above the interests of governments, payers, prescribers and patients. • US companies and foreign companies filing with the US Securities Commissions disclose broadly twice as many risks as non-US filers. • Political instability, natural disasters and the risk posed by the use of information technology had the greatest increase in disclosure. • Emerging market risks are risks disclosed by more than 15% of filers for the first time. Emerging markets face a shortage of qualified staff. • Contingent legal liabilities are dominated by product liabilities, ahead of sales and marketing and patent litigation liabilities. • Large scale merger and acquisition moves in the industry are expected to be challenging. Life cycle of a drug Tracking • Monitoring and reporting of adverse events to govt Authorisation • Submission of safety, efficacy data to regulatory authority • Approvals are for specific indications only • More strict processes to gain eligibility for PBS subsidy Manufacture • Facilities and processes must comply with Good Manufacturing Practice (GMP) code • Quality assurance to licensing requirements a re m et • Audits and active surveillance by TGA Research & Development • Clinical trial registration and protocols • Trial data collection and mandatory monitoring arrangements Marketing • Compliance with industry codes (MA, ASMI, CHC) • Compliance with trade and product legislation
GRC Winter 2012
GRC Summer 2013