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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 Industry Welcomes Moves To Speed Up Access To Innovative Drugs

A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.

France Innovation

New EU Approvals

A listing of EU centralized approvals of new active substances, including brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

European Performance Tracker Approvals

‘Unacceptable’ Medicine Shortages Lead French Senate To Set Up Task Force

Medicine shortages are under scrutiny at national and EU level. In France, a newly established Senate task force is hearing evidence from a range of stakeholders including industry and regulators.

Distribution Manufacturing

Australia Clarifies Regulatory Oversight Of Human Tissues And Cell Products

New rules on the regulation of autologous human cell and tissue products have been introduced in Australia, together with clearer definitions of biological products.

Biologics Australia

Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program

The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.
Approvals Regulation

European Pharmacopoeia Moves Forward With MAb Quality Standards

A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.

Quality Standards
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