We are now six months passed the EU FMD deadline and various organisations like EMVO have begun to ask the authorities to take out sanctions against companies that don’t comply with the FMD regulations.
Oliver Leatham, vice president and global head of value and access at Certara, writes about the complex issues that surrounds assigning a value to new drugs.
Six months on from the Falsified Medicines Directive (FMD) Oliver Pittock, managing director at Valley Northern discusses the status of the directive and the next steps for success.
Ken Moir, VP marketing director at NiceLabel explains why labelling is an unassuming challenge for pharma manufacturers wanting to keep up with regulatory compliance.
Here, Karen Rossington and Siobhan Murphy from Contec guide readers through the implications of the EU Biocidal Products Regulation (BPR) on life science cleanroom users.
Compliance with the EU Ecodesign Directive is driving pharmaceutical manufacturing facilities’ energy consumption up, not down as intended. Jim Heemer and Hugh Reynolds of Jacobs explain the background to this anomaly.
In this whitepaper, Christoph Krähenbühl, senior director of Excellis Europe, explains the challenge new Russian traceability regulations present to the pharma industry.
Erick Gaussens, ProductLife Group’s chief scientific officer, reports on a recent pharmaceutical roundtable which examined why streamlining data management between regulatory and manufacturing needs is a pressing concern for manufacturers.
As temperature control packaging companies develop solutions that answer tighter regulations governing wide-stability products, Clive Bryant, global product and marketing director for Softbox Systems, looks at the challenges they must face.
