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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.

Latest From Ian Schofield

How To Avoid Regulatory Mistakes: Experts Put To The Test

Target product profiles, database locks, infarct size as a surrogate endpoint, and changes in the manufacturing process featured in a session of this year’s TOPRA Symposium on dealing with tricky regulatory questions.

Europe United States

Equitable Access To Vaccines To Figure In Global Pandemic Treaty

Amid growing concern over the new Omicron variant of the coronavirus, member states of the WHO are gathering this week to discuss the negotiation of a convention on future pandemic preparedness and response, with access to medical countermeasures on the agenda. A parallel WTO ministerial meeting that would have discussed the proposed TRIPS IP waiver has been postponed until further notice.

Coronavirus COVID-19 Vaccines

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

Comirnaty mRNA Vaccine First To Get EU Clearance For Under-12s

The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.

Europe Coronavirus COVID-19

EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers

Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.

Europe Drug Review

Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds

The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.

Europe Switzerland
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