Serialisation expert, Christoph Krähenbühl, 3C Integrity, deconstructs the final draft Delegated Act to summarise the key actions required by pharma manufacturers in implementing serialisation programmes
John Welch, Butterworth Laboratories, urges pharmaceutical manufacturers to prepare sooner rather than later for the impending changes to elemental impurities requirements
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
Oliver Wright, solicitor at law firm LHS, says a new high court ruling means improved transparency and a clearer framework for companies operating under regulation by the Health Research Authority
Inna Demidova, head of regulatory affairs for Russia and CIS at ELC Group, looks at the upcoming regulatory requirements in the world’s fastest growing market.
