Stijn Lagaert at LC Patents explains how The European Union member states provide supplementary protection certificates, which may extend the patent life of certain human and veterinary pharmaceuticals for up to five years.
Regulatory guidance for extractables and leachables exists, but only provides general recommendations for ensuring patient safety. Diane Paskiet, Laura Stubbs and Heike Kofler at West Pharmaceutical Services provide an overview of extractable and leachable science.
Patrick Jackson at Vindon Scientific and Dr Carol Barker at XCellR8 provide an insight into how in pharmaceutical research and development, cell culture has an increasing number of cutting-edge roles, including a contribution to reduced attrition rates.
Colin Hayward at Premier Research highlights differences and similarities in the paediatric regulatory compliance strategies and priorities of companies in both EU countries and the US.
Sonja Polan at Life Science Austria discusses how service providers such as good clinical practice specialists help pharma or biotech companies and clinical trial units in Austria.
Dr Jérôme Freissmuth at Robert Bosch GmbH discusses how present developments of new devices are increasingly focused on patients’ needs. They give top priority to simplified handling, reduced pain, continuous documentation and facilitated adherence to medication intervals.
Answering Pharma’s Need for Outsourcing to Process ‘Intensification’ Technology for the Future of Biopharmaceutical Production
Fritjof Linz at DSM Biologics discusses how application of technologies brings down its manufacturing costs through process intensification to offer shorter and more efficient scale-up of (bio)pharmaceuticals, speeding up development, better managing manufacturing volumes and driving down total costs.