The European Medicines Agency (EMA) has published a guide to implementing IDMP data standards that will be ”a game changer” for the life sciences sector. Remco Munnik, who has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, provides the inside track on the implications for life sciences companies.
Post-Brexit, the UK’s MHRA is looking to join Project Orbis, a global program to speed up patient access to innovative cancer treatments. This article looks at the implications of Project Orbis for commercialization in the UK and the key considerations for industry in considering the project as a pathway.
Donald Macarthur and Dr. Meriem Bouslouk-Marx discuss post-approval findings of national committees in Europe charged with deciding the best strategy to use a new COVID-19 vaccine in their populations.
Can private sector serve public interests in battling rare diseases?
How the unfolding of notable infringement claim could alter commercial approaches for players in wider CBD treatment field.
Laura Barrell, Senior Associate at VWV, outlines how the UK is emerging from the trials of Brexit and COVID to take a leading international role in the future of pharma and healthcare.
Sam Pearce, SVP, Head of Europe and International at Jazz Pharmaceuticals, talks about joining the company during a transformative period and how she is working to foster a bold and collaborative culture to expand Jazz’s footprint in Europe and beyond.
There is considerable variation in the regulatory approach to medical cannabis between European countries. Yet, despite the complexity, there are clear routes to market, reports Peter Kohut.
On December 24, 2020, the UK finally agreed a Trade and Cooperation Agreement (TCA) with the EU. Cliodhna McDonough offers some initial thoughts on the implications of the TCA on the life sciences sector.
EU tasked with translating bold declarations into reality.
Must find common ground between digitalization and protection laws.
Must maintain trust in face of customary, non-pandemic challenges.
Universal strategy push elicits range of constituency views.
Orphan drug incentives set to remain in place in Europe.
Christine Phillips looks at how an increase in protectionism across the EU member states with respect to foreign direct investment impacts the life sciences sector.
Budget battle threatens efforts to bolster Europe’s pharma strategy.
Andrew Hood and Cliodhna McDonough look at the key issues necessary to support business and the community in developing a long-term and sustainable response to the challenges highlighted by COVID-19.
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Stephanie Hill looks at the efforts made by patient solutions providers in the UK to build and support services outside the hospital environment during the pandemic.
Pandemic sparks call for European manufacturing renaissance.
Industry prospects at mercy of public discourse, policy shifts.
Pandemic fallout could spell fundamental business and policy shifts.
Ali Mosawi writes about the misconceptions of Iraq's often inhospitable landscape, the essential role of international expertise in driving growth, and how the sector has adapted to meet the challenges of the COVID-19 pandemic.
With coronavirus a stark backdrop, European initiative pushes for “fair” drug prices to spur investment in pharma innovation.
Medical devices manufacturers and pharma companies alike should review their compliance strategies as the EU Medical Device Regulation Date of Application approaches.
