Strategies for Compliant Pharma Sourcing

How regulators, producers and users are meeting the
challenges of globalisation

Objective

The 3rd EFCG Pharma Business Conference, held in Lisbon in May 2008, formed an important milestone in the discussions on the full implementation and enforcement of the new API-related legislation and on the possibilities to protect the patients in EU member states against counterfeit APIs and excipients.

The 4th EFCG Pharma Business Conference in Brussels, Belgium, from 13-14 May 2009 will bring together the key policy and decision makers and major industry stakeholders to discuss the latest regulatory and legislative initiatives that are expected to have a large impact on the global trading and sourcing of pharma raw materials. Furthermore, key proposals for excipients certification and risk classification will be presented.

The topics to be presented and discussed will include:

  • The draft EU Directive on "counterfeit medicines"
  • Aspects of international cooperation on API inspections
  • Customs' view regarding control of API import into Europe
  • The API manufacturing situation in China
  • High-level Panel Discussion on APIs
  • Risk classification approaches for excipients
  • A proposed European Excipients Certification scheme

The conference will include discussions on key aspects of controlling the manufacture and distribution of the widely used Common Excipients with special focus on a European certification scheme. These substances contribute by far the largest weight and volume in most pharmaceutical finished dosage forms.

Target Group

The conference addresses the ingredients supply chains for human and for veterinary medicines, from the producer of raw materials to the user of raw materials.

The conference is designed to promote an inter-disciplinary dialogue by selecting issues that are common to different company functions that may in part have conflicting agendas.

We plan to bring together (senior) pharma business executives, Qualified Persons, QA, RA and purchasing managers as well as EU regulators and inspectors. Executives in general management positions will be able to better understand the issues at stake as a result of the increasing enforcement of compliance and quality.