Webinar: Re-inventing the Pharma Supply Chain: A Blueprint for Success

Advancing root-and-branch change as the only saviour for Pharma supply chains of the future

The (Bio)Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

In response, regulators are demanding tightened controls on the global supply, manufacture, movement and storage of goods intended for human consumption. FDA has produced an important report titled “Pathway to Global Product Safety and Quality” and the European Medicines Agency (EMA) is consulting on radical tightening of Good Distribution Practice (GDP) Guidelines, as follow-on to the Falsified Medicines Directive. We are therefore entering a new era of collaboration from the regulators, whereby they plan to harness technology and networks to share information relating to dysfunction in the supply chain – there will be less and less places to hide as we move forward; also, demands for traceability (pedigree) have now reached fever pitch and regulatory timetables have been put into place to force the pace. The pressure is on for change…