Amplexor’s VP of strategy for life sciences Romuald Braun asks how growing pressure on regulatory data is changing the way firms manage it and what is the best bet exploiting the transformation for the benefit of their own businesses?
Alyn McNaughton, technical director for Lonza Edinburgh, Lonza Pharma & Biotech discusses the requirements and regulations surrounding serialisation legislation.
In preparations for Brexit, the EMA has redistributed the UK’s product portfolio to other EU members and is not allocating any centralised marketing authorisation applications to the MHRA. We take a closer look…
Colin Newbould, the Wasdell Group, discusses upcoming deadlines and what companies should be thinking about as the scope and requirements of track and trace legislation continue to change.
A stark warning that ‘innovation is being hindered by regulators’ has been given by the president of EPCOT International, Girish Malhotra, in the first part of CPhI Worldwide’s sixth annual report.
Earlier this month (9 August) we passed the six-month time point before all companies in Europe will be expected to comply with the falsified medicines directive (FMD).
We have now passed the six month point before the Falsified Medicines Directive (FMD) comes into force. In this online exclusive, Mark Davison, senior operations director, rfxcel insists you ACT NOW! Here are six short reflections.
Earlier this year, the European Commission proposed the introduction of a manufacturing exemption for SPCs. Here, Alexander Kritharidis, Taylor Wessing, London, who is specialising in patents law, goes into more detail…
As we are now a couple of months in after the enforcement of GDPR, we ask Robin Kerbel, CEO and co-founder from Six Degrees Medical* what the impact on the pharma sector is and what may be the wider implications of the regulation changes…
Aflex Hose — a business division of Watson-Marlow Fluid Technology Group — has emphasized the importance of using products that are within the rules and comply with regulatory bodies’ specifications.
In this online exclusive, partners from Hogan Lovells International, Andreas von Falck and Miriam Gundt (Dusseldorf), discuss recent trends in patent protection within the pharmaceutical sector.
