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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

French Patients To Get Pre-Approval Access To Bayer’s Vitravki

Patients in France are to receive Bayer’s Vitravki through an early access scheme pending the product's EU-wide marketing authorization.
France United States

EU ‘Big Data’ Report: Big Opportunities – And Big Challenges

EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug regulatory system can make full use of the rapidly increasing volume and complexity of data being gathered across multiple settings in the healthcare area.

Europe Regulation

UK Industry Skeptical Of Govt’s No-Deal Brexit Filing Expectations

The BioIndustry Association’s latest Brexit webinar looked at issues such as companies’ drug filing strategies in a no-deal scenario as well as the costs that industry is likely to incur as a result of changes to regulatory processes.

United Kingdom Brexit

Australia Considers Identifying Drugs Filed For Approval

The Therapeutic Goods Administration wants to know whether, and how, it should disclose the fact that a medicine has been accepted for regulatory review. It has put several options to stakeholders, including disclosure for all medicines or only certain kinds, or keeping the current practice of “neither confirm nor deny.”
Approvals Drug Review

BIA ‘Reassured’ On Post-Brexit SPC Regime But Data Exclusivity Concerns Remain

The government has said it is prepared to discuss the terms of supplementary protection certificates under a UK-only regime if there is a no-deal Brexit, but concerns also linger over the start dates for regulatory data protection.

Brexit Intellectual Property

UK's NICE Rejects US Industry Attack On Its HTA Methods

The National Institute for Health and Care Excellence does not agree with assertions by the US pharmaceutical industry that its HTA process are “rigid” and “fail to recognize the full value of innovative medicines.”

Pricing Debate Reimbursement
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