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Implementation of Falsified Medicines Directive: Supply Chain Assurance

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Over recent years the Pharmaceutical Industry has moved to more global strategies for R&D, Manufacturing and sourcing of its ingredients.

Dates: Tuesday 18 June 2025
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:

£700.00 excl. VAT – £840.00 incl. VAT per delegate

Type: Pharmaceutical

About this course

Over recent years the pharmaceutical industry has moved to more global strategies for R&D, manufacturing and sourcing of its ingredients. The growth of outsourcing, often to countries with less mature pharmaceutical industry understanding and regulatory systems, has also been significant as companies seek to lower their costs of operating.

In parallel, significant public health issues have occurred related to the supply chain of excipients (e.g. Glycerol), APIs (e.g. Heparin) and counterfeiting of finished medicinal products. The response from the European Commission and FDA has been to propose new legislation to mitigate the risks.

This course will cover the proposals from the regulators, the responses from the pharmaceutical industry, its suppliers of excipients and APIs, and related associations, along with good industry practices for ‘end to end’ supply chain assurance.

What You Will Learn

  • FDA initiatives and views on supply chain assurance
  • EU initiatives and views on supply chain assurance
  • What has gone wrong – case study
  • Views and proposals from excipient and API suppliers
  • Examples of industry practices for supply chain assurance
  • Key steps to combat the counterfeiter
  • The risks to the company, the industry, the patient

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