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regulations

Based on its latest report, data and analytics company — GlobalData — has revealed that North Americans are the least informed about the General Data Protection Regulation (GDPR). more

News

In this online exclusive, Alex Aves, marketing executive, Rephine, looks at blockchain in more detail including how it may benefit the pharmaceutical sector. more

Opinion

The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented changes to the licence for valproate medicines — Epilim, Depakote and generics used to treat epilepsy and bipolar disorder — in the interest of public safety. more

News

Pharmaceutical companies are unwittingly putting production processes at risk of contamination by fitting mechanical seals which fail to comply with EU regulations. says John Smiddy, European Sales and Technical Support Director for AESSEAL. more

Opinion

The International Society for Cellular Therapy (ISCT) has stated its support of the US Food and Drug Administration’s (FDA’s) new comprehensive Regenerative Medicine Policy Framework. more

News

ABPI responds positively to a letter in the Financial Times from health secretary, Jeremy Hunt, and business secretary, Greg Clark, which lays out plans for the regulation of medicines in the UK after the country leaves the European Union. more

News

Arvato Systems has been tasked with the implementation and operation of the Medication Verification IT platform for the Austrian Medicines Verification Organisation (AMVO). more

News

The Food and Drug Administration (FDA), under new commissioner Scott Gottlieb, will be taking more of an active role in the issues surrounding drug prices, according to various US news sources. more

News

Shabbir Dahod, president and CEO of TraceLink, highlights insights to take from DSCSA to help with EU FMD. more

News

According to a new study published in JAMA, institutions and organisations can play a role in the relationships between doctors and the drug industry and this may affect which drugs are prescribed to patients. more

News

On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation. more

News

Torben Vogt, pharma director at Videojet Technologies, talks to EPM about implementing coding and marking systems for serialisation. more

Opinion

Michael Gove, former cabinet minister and Conservative politician, highlighted EU regulations on clinical trials for new drugs as something that, in his opinion, holds back UK businesses. more

News

Dr. Andreas Nixdorf, business development manager, extractables and leachables testing at SGS - Life Sciences, examines new developments in safety, toxicity and E&L standards for single use manufacturing. more

News

EPM catches up with Kevin Lawler, vice president of worldwide sales at Pelican BioThermal to discuss all things cold chain. more

News

Leslie Morgan, CEO of Durbin talks about industry regulations, Managed Access Programmes and the future of pharma more

Opinion

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Image: Jimmie48 Photography

Maria Sharapova has failed a drugs doping test at the Australian Open. Changes in regulations mean meldonium, once a prescription drug taken by the athlete, has now been banned more

Opinion

Farzad Henareh, Stericycle ExpertSolutions, discusses taking responsibility for product safety, regulation and classification more

Opinion

Robert Gaertner, director strategy, Veeva QualityDocs Europe, looks at the way that digitisation has changed life sciences and what the future holds, including technology development and upcoming regulatory requirements more

Opinion

Professor Sam Salek, School of Medical and Life Sciences, University of Hertfordshire, calls for a “universal framework” to speed up the disjointed decision-making process around the commissioning of new drugs more

Opinion