Improved VHP to Benefit European Clinical Trials
Getting new innovative medicines to patients more quickly has become a step change easier thanks to the improved and refined Voluntary Harmonisation Procedure (VHP) for multinational clinical trials applications that the BioIndustry Association (BIA) has long campaigned for.
Steve Bates, BIA CEO, said: "This voluntary system agreed by national regulatory authorities makes running multinational clinical trials across the EU simpler and cheaper. The BIA has advocated for these changes for a number of years and is delighted that they are making a practical difference to companies.
"I want to make sure all companies are aware of this procedure and use it - especially if the proposed EU Regulation on clinical trials is delayed for any reason."
Key changes to the VHP include: A Reference National Competent Authority responsible for the scientific assessment, consolidation of questions and grounds for non-acceptance, and the reassessment of the sponsor's response in collaboration with the National Competent Authorities (NCAs) concerned by the trial and participating in the VHP. Second- wave VHP' of clinical trial applications allowing sponsors to include additional Members States following a positive VHP and taking account of the original assessment.
Alan Morrison, Vice President, International Regulatory Affairs and Safety, Amgen, and Chairman of BIA's Regulatory Affairs Advisory Committee, said: "The BIA's Regulatory Affairs Advisory Committee has campaigned to improve the
BioTek Instruments Wins Workplace Safety Award
The Vermont Safety & Health Council, and the Vermont Small Business Development Centre recently presented BioTek with the 2013 “Governor’s Award for Outstanding Workplace Safety” in the Large Business category at a ceremony in South Burlington, VT.
The award, given by Governor Peter Shumlin at the 9th Annual Vermont Workplace Safety Conference, is the highest honour given by the State in recognition of an employer’s commitment to excellence in
workplace safety and health. BioTek received the accolade for its continuous education through trainings and newsletters, formal documentation and prevention/improvement procedures, and company- wide workplace safety participation.
“Our employees are our most valuable resource, so keeping them safe is a top priority,” noted Bob Dunn, BioTek’s
Manufacturing Supervisor. “Ongoing
education and awareness at every level helps to keep BioTekkers safe every day.”
MORE INFO. 47 Eppendorf Posts Successful 2012
The Eppendorf Group performed well in fiscal year 2012, generating sales of more than €500 million for the first time. Sales increased by 8.9% year on year to €520.2 million (prior year: €477.7 million). Organic growth, after adjustment for currency effects and acquisitions, was 4.0%. Income from operations (EBIT) improved by 11.5 percent to €101.5 million (prior year: €91 million). Net income in 2012 rose to €70.6 million, which is 14% over fiscal 2011. In order to keep on developing its product portfolio, the Group increased its investments in research and development in 2012 by 10.7% to a total of €27.5 million (prior year: €24.9
million). Eppendorf also invested in expanding its international sales footprint and opened new sales companies in Korea and Russia.
“In view of the challenging market environment for our industry, we can be satisfied with how we did in fiscal 2012,” said Dr Dirk Ehlers, CEO of Eppendorf AG. “In 2012 we expanded our Cell Handling application area by acquiring the DASGIP Group, an important addition for us. Continuous development of our product portfolio, whether through research and development or through acquisitions, will remain a focus of our activities in 2013,” added Ehlers.
MORE INFO. 48 Lee Oakley
British autoclave manufacturer Priorclave has announced the appointment of Lee Oakley as Sales Director, following the company’s continued successful growth and key expansion plans into global markets.
Lee, who joined Priorclave in November 2005 had made a significant impact in developing and motivating UK distributor sales, helping increase turnover year-on-year, said the company.
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In addition to being responsible for managing and developing UK sales, primarily through an established distributor network and service support, Lee takes on responsibility for exploring new business opportunities through product development and new target markets including Europe and Africa.
MORE INFO. 49
regulatory framework for clinical trials in the EU since 2006. Greater harmonisation of clinical trial authorisation review processes and cooperation among Member States are important to provide consistency to trial approval to the ultimate benefit of both patients and the life sciences sector.
Every company should be using the VHP for multinational trials; only by building this experience can we be prepared to work effectively within the new regulatory framework when the EU clinical trials Regulation comes into force.
"We pay tribute to the dedication of Dr Hartmut Krafft, the Chair of the CTFG and VHP-Coordinator, and the leading role of the Paul-Ehrlich Institute in getting the VHP this far."
MORE INFO. 46
Priorclave Appoints New Sales Director
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