Press Area

DIA 22nd Annual EuroMeeting: Diapharm pushes for a paradigm shift in the legislation for OTC products

Münster (Germany), 10 March 2010.  Due to the undifferentiated regulations in the European market for over-the-counter (OTC) medicinal products, a paradigm shift in the legislation is overdue. This point was emphasised by Dr Annemarie Jasper, manager of business development services for the pharmaceutical service provider Diapharm (www.diapharm.com) during the DIA 22nd Annual EuroMeeting in Monaco. At the largest European symposium for the pharmaceutical sector, which was attended by more than 3,000 experts from private companies, public authorities and universities, Jasper criticised the constant growth in legal regulations that are valid not only for medicinal products requiring prescriptions, but also for non-prescription OTC products.

Increased safety through accredited, cost-efficient audits: Diapharm organizes worldwide API/GMP audits

Münster (Germany), 8 March 2010.  In 2010, the pharmaceutical service provider Diapharm (www.diapharm.com) is again offering worldwide API/GMP audits of API manufacturing sites with a focus on Europe, China and India. Diapharm made this announcement on the occasion of the DIA Annual Euro Meeting in Monaco. During these trips, different active pharmaceutical ingredients (APIs) from different customers are audited for GMP compliance, grouped together by API manufacturing site and region. This audit sharing is extremely cost-efficient. "With these accredited third-party audits, we enable pharmaceutical companies to control their API production at the highest level,” explains Martin Vortkamp, who is in charge of the shared audit service at Diapharm. "The confidentiality interests of all participating companies have always highest priority.”

An innovative path: oral eubiotic certified as a medical device

Münster, Berlin (Germany), 1 March 2010.  The pharmaceutical service provider Diapharm (www.diapharm.com) and the contract manufacturer Med Pharma Service (www.medpharmaservice.de) have succeeded in developing an innovative medical device that works naturally for the regeneration of intestinal functions for non-specific diarrhoea or for diarrhoea after antibiotics therapy. Together, these two companies have brought the new medical device with the eubiotic Lactobacillus johnsonii to market. The hard capsules will be sold as a class III medical device under the trade names of selected sales partners. "The certification by the notified body is already completed, which means that the product is now marketable,” says Dr Annemarie Jasper, who manages the development project for Diapharm.

Diapharm adds Axel Turowski to its Health Food consultancy team

Münster (Germany), 17 February 2010.  In early February, Axel Turowski, who holds a graduate degree in nutritional science, joined the Health Food team at Diapharm, the pharmaceutical industry service provider (www.diapharm.com). As Manager of Regulatory Affairs, Non-Pharma, the 44-year-old advises manufacturers of food supplements on regulatory issues, for example concerning categorisation of products for optimum marketability and the EC Health Claims Regulation. Diapharm assists companies in the pharmaceutical and health products industries in the areas of regulatory affairs, clinical development, quality and business development.

3rd Annual Stability Testing Conference in London: Stability Testing in a European and Global Context

London (UK), Oldenburg (Germany), 27 November 2009:.  In November, R&D and quality-control experts from the industry and universities throughout Europe met in London to discuss how stability testing for pharmaceuticals could be made as meaningful and efficient as possible. Among the 13 key speakers at the Third Annual Stability Testing Conference were Dr Sabine Boeckle, Group Head of Analytical R&D at Hoffmann La Roche (www.roche.ch), Dr Paul Royall of the Department of Pharmaceutics at King's College, London (www.kcl.ac.uk) and Dr Sven Oliver Kruse, Head of Analytical Services and CEO of the Diapharm Service Laboratory (www.diapharm.com).

The spectre of product recalls on the doorstep of the food industry

Münster (Germany), 5 November 2009.  In 2010, multiple sales prohibitions may be imposed on food – and especially on food supplements – as advertising claims are deemed impermissible, fears Andrea Stemmer from the health care industry consultant Diapharm (www.diapharm.com). The background to this situation is the impending stepwise publication of partial lists on permitted food health claims by the EU Commission.

Dr Wilfried Dierkes new head of Clinical Project Management at Diapharm

Oldenburg, 14 September 2009.  With effect from September, Dr Wilfried Dierkes has been recruited to the Medical and Clinical Development division at Diapharm (www.diapharm.de) in Oldenburg, Germany. From now on he will be responsible for performing clinical studies and preparing clinical expert reports for the pharmaceutical service provider. Dr Wilfried Dierkes brings 17 years’ experience in the field of clinical research.

Diapharm to offer readability user testing in Romania

Bucharest (RO), Oldenburg (GE), 1 September 2009.  Diapharm Clinical Management GmbH (www.diapharm.com) is opening an office in Bucharest. From September the pharmaceutical service provider will carry out readability tests on package information leaflets for use in Romania. The new Bucharest office will be managed by Dr Ioana Schmidt. Diapharm runs other testing centres in the United Kingdom and Germany for readability user testing. Medicinal products can only be marketed in Europe once it has been demonstrated that, additionally to the safety, quality and efficacy of the medication, the enclosed instructions for use are comprehensible.

Diapharm registers another seven Herbal Medicinal Products in the UK – other countries are to follow

Münster (Germany), 30 July 2009.  In early July, Diapharm (www.diapharm.com) obtained registrations from the MHRA in the UK for two Traditional Herbal Medicinal Products (THMP) containing Devil’s claw, two containing Passion flower and one containing Black cohosh. On 30 July, the agency also granted two registrations for Feverfew products. Diapharm will not bring these products to market itself, however, but offer them to pharmaceutical manufacturers. The registration dossiers are also to be submitted in other European countries – continuing the pharmaceutical service provider's internationalisation strategy. "Already, around a quarter of all registrations in the European Union and as many as half in the UK are based on Diapharm dossiers,” explains General Manager Dr. Rainer Kolkmann. The pharmaceutical service provider is handling similar procedures in Germany, the UK, France, the Netherlands, Lithuania, Austria, Portugal, Poland, Spain, the Czech Republic and Hungary.

Moving to Diapharm: Former manager at Teva Martin Vortkamp takes over as Head of Business Development

Münster (Germany), 21 July 2009.  Diapharm (www.diapharm.com) has hired Martin Vortkamp as manager of the Business Development division. He comes to the pharmaceutical service provider from Teva, where he was responsible for the portfolio and business development of the generics manufacturer. Martin Vortkamp's role at Diapharm will include driving forward internationalisation and development of new areas of business, such as the GMP audit sector.