Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Francesca Bruce

Senior Writer

Francesca writes about a broad range of policy and regulatory topics, including intellectual property rights. However, her main areas of expertise are pricing and reimbursement and how medicines may or may not make it to patients. She writes about developments in Europe and is also expanding coverage in emerging markets, including Latin America and the Middle East. Francesca writes for Pink Sheet, Scrip and In Vivo.

Latest From Francesca Bruce

EU Substances Of Human Origin Regulation Set To Pass Final Milestones

New regulation on  substances of human origin (SoHO) will help improve Europe’s “strategic autonomy” and improve access to such substances, say industry representative.

Europe Biologics

EU HTA Regulation: Draft Conflicts Of Interest Rules Fail To Consider Orphan Drugs

Coupled with a recent top court ruling, the draft implementing act on CoIs under the Health Technology Assessment Regulation show a general trend towards stricter conflicts of interest rules.

Europe Health Technology Assessment

‘Pivotal’ Regulation On EU Joint Clinical Assessments Extends Dossier Deadlines

Despite changes, industry remains concerned over the EU implementing regulation that sets out procedures for joint clinical assessments.

Europe Health Technology Assessment

Joint Clinical Assessments Of ATMPs Add To Ethical Concerns Over Need For Randomized Trials

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.

Europe Drug Approval Standards

European Commission Dangles Conditional Approval Reprieve For PTC Therapeutics’ Translarna

Scientific questions from member state experts and a recent court ruling on impartiality in the drug approval process prompted the European Commission to query the EMA’s negative opinion on PTC’s Translarna.

Europe Drug Review

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

South America Colombia
See All
UsernamePublicRestriction

Register