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Ian Schofield

Edinburgh, U.K
Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs.  As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients. He has a degree in modern languages from the University of Bath. Outside the realm of work, Ian plays guitar in a traditional music group and also enjoys a touch of cycling and gardening. He lives by the seaside about three miles from the centre of Edinburgh.
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Latest From Ian Schofield

Spain Investigates Metamizole Risks In Expat Britons

Metamizole is in the safety spotlight again after the Spanish regulator said it was investigating reports of deaths and serious side-effects in expatriate and holidaymaking Britons caused by the painkiller. 

Drug Safety Spain

Australian Patent Reforms Target Inventive Step, Innovation Patents

Major changes are being proposed to the Australian patent system, including an end to the “innovation patent” system and a higher threshold for the “inventive step” requirement.
Intellectual Property Australia

UK Promises ‘Competitive’ Clinical Trial Process Whatever The Brexit Outcome

The UK pharmaceutical industry has welcomed government guidance on the clinical trial regulatory landscape after Brexit, as well as a report from Cancer Research UK on the need to preserve alignment with the EU’s Clinical Trial Regulation.
Clinical Trials Brexit

CJEU Ruling Could Prove Problematic For Gilead’s Truvada SPC

A ruling by the Court of Justice of the EU has attempted to clarify the situation regarding the conditions for a supplementary protection certificate, but while it may help to settle the UK case regarding Gilead’s combination HIV drug Truvada, one practitioner says the case raises more questions than it answers.
Intellectual Property Europe

UK Regulatory Changes During A Brexit Transition Period – The Government Explains All

Guidance documents on the regulation of medicines in the UK during a Brexit transition period have been published by the government, covering areas like batch release, drug approvals, and the role of the UK MHRA in the EU regulatory system.

Brexit United Kingdom

EC Proposes Specific Clinical Trial Requirements For ATMPs

A new EU draft guideline on clinical trials with ATMPs outlines a number of areas where specific requirements and safeguards might be needed when testing these often complex and novel products in humans.

Clinical Trials Europe
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